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    Chemistry

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    Also known as: Methylphenidan, Phenidylate, Calocain, Plimasine, 113-45-1, Concerta
    Molecular Formula
    C14H19NO2
    Molecular Weight
    233.31  g/mol
    InChI Key
    DUGOZIWVEXMGBE-UHFFFAOYSA-N
    Methylphenidate
    A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE.
    1 2D Structure

    Methylphenidate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    methyl 2-phenyl-2-piperidin-2-ylacetate
    2.1.2 InChI
    InChI=1S/C14H19NO2/c1-17-14(16)13(11-7-3-2-4-8-11)12-9-5-6-10-15-12/h2-4,7-8,12-13,15H,5-6,9-10H2,1H3
    2.1.3 InChI Key
    DUGOZIWVEXMGBE-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    COC(=O)C(C1CCCCN1)C2=CC=CC=C2
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Centedrin

    2. Concerta

    3. Daytrana

    4. Equasym

    5. Hydrochloride, Methylphenidate

    6. Metadate

    7. Methylin

    8. Methylphenidate Hydrochloride

    9. Phenidylate

    10. Ritalin

    11. Ritalin Sr

    12. Ritalin-sr

    13. Ritaline

    14. Tsentedrin

    2.2.2 Depositor-Supplied Synonyms

    1. Methylphenidan

    2. Phenidylate

    3. Calocain

    4. Plimasine

    5. 113-45-1

    6. Concerta

    7. Methyl Phenidylacetate

    8. Methyl Phenidate

    9. Metilfenidato [italian]

    10. Methylphenidatum

    11. Metilfenidato [inn-spanish]

    12. Methylphenidatum [inn-latin]

    13. 4311/b Ciba

    14. Methyl Phenidyl Acetate

    15. Methyl Phenyl(piperidin-2-yl)acetate

    16. Methylin

    17. Methyl Alpha-phenyl-alpha-(2-piperidyl)acetate

    18. Alpha-phenyl-2-piperidineacetic Acid Methyl Ester

    19. Daytrana

    20. Methylphenidate Hcl

    21. Nci-c56280

    22. 2-piperidineacetic Acid, Alpha-phenyl-, Methyl Ester

    23. Methyl Alpha-phenyl-alpha-2-piperidinylacetate

    24. Chembl796

    25. 2-piperidineacetic Acid, .alpha.-phenyl-, Methyl Ester

    26. Methyl 2-phenyl-2-(piperidin-2-yl)acetate

    27. Methylfenidan

    28. Chebi:84276

    29. Metilfenidato

    30. Methylphenidylacetate Hydrochloride

    31. .alpha.-phenyl-2-piperidineacetic Acid Methyl Ester

    32. D-methylphenidate Hcl

    33. Cotempla Xr-odt

    34. Daytrana (tn)

    35. Threo-dl-methylphenidate

    36. Methyl 2-phenyl-2-piperidin-2-ylacetate

    37. Hsdb 3126

    38. Methyl (2-phenyl-2-(2-piperidyl)acetate)

    39. Prc-063

    40. Einecs 204-028-6

    41. C 4311

    42. Methylphenidate Extended Release

    43. Methylphenidate (usan/inn)

    44. Rubifen

    45. Alpha-phenyl-alpha-(2-piperidyl)acetic Acid Methyl Ester

    46. Dea No. 1724

    47. Methylphenidate [usan:inn:ban]

    48. 40572-71-2

    49. Ritalin (salt/mix)

    50. Methylin (salt/mix)

    51. Ritaline (salt/mix)

    52. Centedein (salt/mix)

    53. Centedrin (salt/mix)

    54. Centedrine (salt/mix)

    55. Schembl37178

    56. Gtpl7236

    57. Dtxsid5023299

    58. Jornay Pm (a.k.a. Hld200)

    59. Bcp18286

    60. Hy-b1091

    61. Bdbm50062912

    62. Methyl Alpha-piperid-2-ylphenylacetate

    63. Methyl Phenyl(2-piperidinyl)acetate #

    64. Cs-4657

    65. Db00422

    66. Ncgc00248587-01

    67. Ncgc00248587-03

    68. Methyl .alpha.-phenyl-2-piperidineacetate

    69. Sbi-0206868.p001

    70. Methyl .alpha.-phenyl-2-piperidine-acetate

    71. C07196

    72. D04999

    73. Phenyl-piperidin-2-yl-acetic Acid Methyl Ester

    74. Ab01563134_01

    75. 2-piperidineacetic Acid, ?-phenyl-, Methyl Ester

    76. L001307

    77. Q422112

    78. Methyl .alpha.-phenyl-.alpha.-(2-piperidyl)acetate

    79. Methyl .alpha.-phenyl-.alpha.-2-piperidinylacetate

    80. (s,2s)--phenyl-2-piperidineacetic Acid Methyl Ester

    81. Brd-a19585813-003-01-7

    2.3 Create Date
    2005-03-25
    3 Chemical and Physical Properties
    Molecular Weight 233.31 g/mol
    Molecular Formula C14H19NO2
    XLogP30.2
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count4
    Exact Mass233.141578849 g/mol
    Monoisotopic Mass233.141578849 g/mol
    Topological Polar Surface Area38.3 Ų
    Heavy Atom Count17
    Formal Charge0
    Complexity249
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count2
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 20  
    Drug NameConcerta
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelCONCERTA is a central nervous system (CNS) stimulant. CONCERTA is available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength54mg; 18mg; 27mg; 36mg
    Market StatusPrescription
    CompanyJanssen Pharms

    2 of 20  
    Drug NameDaytrana
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelDaytrana is an adhesive-based matrix transdermal system (patch) that is applied to intact skin. The chemical name for methylphenidate is -phenyl-2-piperidineacetic acid methyl ester. It is a white to off-white powder and is soluble in alcohol, ethy...
    Active IngredientMethylphenidate
    Dosage FormFilm, extended release
    RouteTransdermal
    Strength30mg/9hr (3.3mg/hr); 15mg/9hr (1.6mg/hr); 10mg/9hr (1.1mg/hr); 20mg/9hr (2.2mg/hr)
    Market StatusPrescription
    CompanyNoven Pharms

    3 of 20  
    Drug NameMetadate cd
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMETADATE CD is a central nervous system (CNS) stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by t...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormCapsule, extended release
    RouteOral
    Strength30mg; 50mg; 60mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyUcb

    4 of 20  
    Drug NameMetadate er
    PubMed HealthMethylphenidate (By mouth)
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMETADATE ER Tablets (methylphenidate hydrochloride extended-release tablets, USP) are a mild central nervous system (CNS) stimulant. METADATE ER is available as 20 mg extended-release tablets for oral administration.Methylphenidate hydrochloride is m...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength20mg
    Market StatusPrescription
    CompanyUcb

    5 of 20  
    Drug NameMethylin
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMethylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available for oral administration as tablets of 5 mg, 10 mg, and 20 mg and as extended-release tablets of 10 mg and 20 mg. Methylphenidate hydrochloride is methyl -phen...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, chewable; Solution
    RouteOral
    Strength2.5mg; 10mg/5ml; 5mg; 10mg; 5mg/5ml
    Market StatusPrescription
    CompanyMallinckrodt

    6 of 20  
    Drug NameMethylin er
    Drug LabelMethylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available for oral administration as tablets of 5 mg, 10 mg, and 20 mg and as extended-release tablets of 10 mg and 20 mg. Methylphenidate hydrochloride is methyl -phen...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength10mg; 20mg
    Market StatusPrescription
    CompanyMallinckrodt

    7 of 20  
    Drug NameQuillivant xr
    Drug LabelQUILLIVANT XR is a powder that, after reconstitution with water, forms an extended-release oral suspension formulation of methylphenidate intended for once daily oral administration. QUILLIVANT XR contains approximately 20% immediate-release and 80%...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormFor suspension, extended release
    RouteOral
    Strength5mg/ml
    Market StatusPrescription
    CompanyNextwave Pharms

    8 of 20  
    Drug NameRitalin
    Drug LabelRitalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system (CNS) stimulant, available as tablets of 5, 10, and 20 mg for oral administration; Ritalin-SR is available as sustained-release tablets of 20 mg for oral admin...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg; 20mg
    Market StatusPrescription
    CompanyNovartis

    9 of 20  
    Drug NameRitalin la
    Drug LabelMethylphenidate hydrochloride is a central nervous system (CNS) stimulant. Ritalin LA (methylphenidate hydrochloride) extended-release capsules is an extended-release formulation of methylphenidate with a bi-modal release profile. Ritalin LA uses t...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormCapsule, extended release
    RouteOral
    Strength30mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyNovartis

    10 of 20  
    Drug NameRitalin-sr
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength20mg
    Market StatusPrescription
    CompanyNovartis

    11 of 20  
    Drug NameConcerta
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelCONCERTA is a central nervous system (CNS) stimulant. CONCERTA is available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength54mg; 18mg; 27mg; 36mg
    Market StatusPrescription
    CompanyJanssen Pharms

    12 of 20  
    Drug NameDaytrana
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelDaytrana is an adhesive-based matrix transdermal system (patch) that is applied to intact skin. The chemical name for methylphenidate is -phenyl-2-piperidineacetic acid methyl ester. It is a white to off-white powder and is soluble in alcohol, ethy...
    Active IngredientMethylphenidate
    Dosage FormFilm, extended release
    RouteTransdermal
    Strength30mg/9hr (3.3mg/hr); 15mg/9hr (1.6mg/hr); 10mg/9hr (1.1mg/hr); 20mg/9hr (2.2mg/hr)
    Market StatusPrescription
    CompanyNoven Pharms

    13 of 20  
    Drug NameMetadate cd
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMETADATE CD is a central nervous system (CNS) stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by t...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormCapsule, extended release
    RouteOral
    Strength30mg; 50mg; 60mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyUcb

    14 of 20  
    Drug NameMetadate er
    PubMed HealthMethylphenidate (By mouth)
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMETADATE ER Tablets (methylphenidate hydrochloride extended-release tablets, USP) are a mild central nervous system (CNS) stimulant. METADATE ER is available as 20 mg extended-release tablets for oral administration.Methylphenidate hydrochloride is m...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength20mg
    Market StatusPrescription
    CompanyUcb

    15 of 20  
    Drug NameMethylin
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMethylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available for oral administration as tablets of 5 mg, 10 mg, and 20 mg and as extended-release tablets of 10 mg and 20 mg. Methylphenidate hydrochloride is methyl -phen...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, chewable; Solution
    RouteOral
    Strength2.5mg; 10mg/5ml; 5mg; 10mg; 5mg/5ml
    Market StatusPrescription
    CompanyMallinckrodt

    16 of 20  
    Drug NameMethylin er
    Drug LabelMethylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available for oral administration as tablets of 5 mg, 10 mg, and 20 mg and as extended-release tablets of 10 mg and 20 mg. Methylphenidate hydrochloride is methyl -phen...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength10mg; 20mg
    Market StatusPrescription
    CompanyMallinckrodt

    17 of 20  
    Drug NameQuillivant xr
    Drug LabelQUILLIVANT XR is a powder that, after reconstitution with water, forms an extended-release oral suspension formulation of methylphenidate intended for once daily oral administration. QUILLIVANT XR contains approximately 20% immediate-release and 80%...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormFor suspension, extended release
    RouteOral
    Strength5mg/ml
    Market StatusPrescription
    CompanyNextwave Pharms

    18 of 20  
    Drug NameRitalin
    Drug LabelRitalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system (CNS) stimulant, available as tablets of 5, 10, and 20 mg for oral administration; Ritalin-SR is available as sustained-release tablets of 20 mg for oral admin...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg; 20mg
    Market StatusPrescription
    CompanyNovartis

    19 of 20  
    Drug NameRitalin la
    Drug LabelMethylphenidate hydrochloride is a central nervous system (CNS) stimulant. Ritalin LA (methylphenidate hydrochloride) extended-release capsules is an extended-release formulation of methylphenidate with a bi-modal release profile. Ritalin LA uses t...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormCapsule, extended release
    RouteOral
    Strength30mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyNovartis

    20 of 20  
    Drug NameRitalin-sr
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength20mg
    Market StatusPrescription
    CompanyNovartis

    4.2 Therapeutic Uses

    Central Nervous System Stimulants; Dopamine Uptake Inhibitors

    National Library of Medicine's Medical Subject Headings. Methylphenidate. Online file (MeSH, 2015). Available from, as of November 20, 2015: https://www.nlm.nih.gov/mesh/2015/mesh_browser/MBrowser.html

    /CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Methylphenidate is included in the database.

    NIH/NLM; ClinicalTrials.Gov. Available from, as of September 30, 2015: https://clinicaltrials.gov/search/intervention=methylphenidate

    MEDICATION (VET): Methylphenidate may be useful for diagnosing and treating cataplexy/narcolepsy or hyperactivity in dogs.

    Plumb D.C. Veterinary Drug Handbook. 8th ed. (pocket). Ames, IA: Wiley-Blackwell, 2015., p. 957

    Treatment of cocaine abuse with agonists such as methylphenidate has been attempted, but with litle success except in patients with attention deficit disorders.

    DHHS/NIDA; Research Monograph Series 88: Mechanisms of Cocaine Abuse and Toxicity p.125 (1988) DHHS Pub No. (ADM)89-1585

    For more Therapeutic Uses (Complete) data for METHYLPHENIDATE (7 total), please visit the HSDB record page.

    4.3 Drug Warning

    Methylphenidate should be used with caution in patients with hypertension. Blood pressure should be monitored at appropriate intervals in patients receiving the drug, especially those with hypertension.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2552

    Hypersensitivity reactions including rash, macular rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathologic findings of necrotizing vasculitis, and thrombocytopenic purpura may occur in patients receiving methylphenidate. Stevens-Johnson syndrome has been reported rarely. Fixed drug eruption, angioedema, anaphylactic reaction, auricular swelling, bullous conditions, pruritus, eruptions, and exanthemas have been reported in patients receiving methylphenidate, although a definite causal relationship has not been established. Erythema occurs in a majority of patients receiving methylphenidate as the transdermal system but generally causes minimal or no discomfort.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2551

    Abnormal liver function, ranging from serum aminotransferase (transaminase) elevations to hepatic coma, has been reported in patients receiving methylphenidate, although a definite causal relationship has not been established. Hepatotoxicity was associated with methylphenidate therapy in at least one patient.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2551

    The most frequent adverse effects of methylphenidate appear to be dose related and include nervousness and insomnia.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2551

    For more Drug Warnings (Complete) data for METHYLPHENIDATE (23 total), please visit the HSDB record page.

    4.4 Drug Indication

    Methylphenidate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older and for the treatment of narcolepsy.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Methylphenidate is a racemic mixture comprised of the d- and l-isomers. The d-isomer is more pharmacologically active than the l-isomer. Radioligand binding studies demonstrate that binding of methylphenidate in the brain is localized to dopamine-rich areas, in particular in the prefrontal cortex which has been demonstrated to play a prominent role in ADHD pathophysiology. In a number of animal models, methylphenidate enhances locomotor activity and induces stereotypic behaviours.

    5.2 MeSH Pharmacological Classification

    Central Nervous System Stimulants

    A loosely defined group of drugs that tend to increase behavioral alertness, agitation, or excitation. They work by a variety of mechanisms, but usually not by direct excitation of neurons. The many drugs that have such actions as side effects to their main therapeutic use are not included here. (See all compounds classified as Central Nervous System Stimulants.)

    Dopamine Uptake Inhibitors

    Drugs that block the transport of DOPAMINE into axon terminals or into storage vesicles within terminals. Most of the ADRENERGIC UPTAKE INHIBITORS also inhibit dopamine uptake. (See all compounds classified as Dopamine Uptake Inhibitors.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Central Nervous System Stimulation [PE]; Central Nervous System Stimulant [EPC]
    5.4 ATC Code

    N06BA04

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    N - Nervous system

    N06 - Psychoanaleptics

    N06B - Psychostimulants, agents used for adhd and nootropics

    N06BA - Centrally acting sympathomimetics

    N06BA04 - Methylphenidate

    5.5 Absorption, Distribution and Excretion

    Absorption

    Concerta: Methylphenidate is readily absorbed. Following oral administration of Concerta, plasma methylhphenidate concentrations reach an initial maximum at about 1 hour followed by gradual ascending concentrations over the next 5-9 hours. Mean times to reach peak plasma concentrations across all doses of Concerta occurred between 6-10 hours. Once daily dosing minimizes the fluctuations between peak and trough concentrations associated with multiple doses of immediate-release methylphenidate treatments. Depending on the doses provided, Cmax was found to range from 6.0-15.0ng/mL, Tmax ranged from 8.1-9.4h, and AUC ranged from 50.4-121.5 ngh/mL in children. When provided as Concerta, methylphenidate is released through the patented Osmotic Controlled-Release Oral Delivery (OROS) system where 22% of the dose is provided as an immediate release and 78% is provided through a gradual release. OROS is comprised of an osmotically active trilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. Within an aqueous environment, such as the stomach, the drug overcoat, which consists of 22% of the dose, dissolves within one hour, providing an initial immediate-release formulation of methylphenidate. Water then permeates through the membrane into the tablet core where the osmotically active polymer excipients expand, allowing methylphenidate to release slowly through the orifice over a period of 6-7 hours. Concerta also provides a sustained 10-12 hour effect, allowing for once-daily dosing. Biphentin: Methylphenidate is rapidly and extensively absorbed following oral administration, with peak blood levels obtained in 1-3 hours. When provided as Biphentin, methylphenidate is released through a multi-layer release delivery system (MLRTM) where 40% of the dose is provided as an immediate release and 60% is provided through a gradual release. Biphentin was designed to be an alternative to separate doses of immediate-release (IR) methylphenidate by providing a biphasic concentration-time profile when given as a single dose. The MLRTM release system allows for a sustained effect for 10-12 hours, allowing for once-daily dosing that covers the major times that ADHD impairment might occur (such as school, homework periods, during the workday, etc). Methylphenidate (immediate release): Methylphenidate hydrochloride is rapidly and extensively absorbed from the tablets following oral administration; however, owing to extensive first-pass metabolism, bioavailability is low (approx. 30%) and large individual differences exist (11-52%). In one study, the administration of methylphenidate hydrochloride with food accelerated absorption but had no effect on the amount absorbed. Peak plasma concentrations of 10.8 and 7.8 ng/mL were observed, on average, 2 hours after administration of 0.30 mg/kg in children and adults, respectively. Peak plasma concentrations showed marked variability between subjects. Both the area under the concentration-time curve (AUC), and the peak plasma concentrations (Cmax) showed dose-proportionality.

    Route of Elimination

    After oral administration of an immediate release formulation of methylphenidate, 78%-97% of the dose is excreted in the urine and 1%-3% in the feces in the form of metabolites within 48-96 hours. Only small quantities (<1%) of unchanged methylphenidate appear in the urine. Most of the dose is excreted in the urine as ritalinic acid (60%-86%), the remainder being accounted for by minor metabolites.

    Volume of Distribution

    Concerta: Plasma methylphenidate concentrations in adults decline bi-exponentially following oral administration. Biphentin: The apparent distribution volume of methylphenidate in children is approximately 20 L/kg, with substantial variability (11 to 33 L/kg). Methylphenidate (immediate release): The apparent distribution volume of methylphenidate in children was approximately 20 L/kg, with substantial variability (11-33 L/kg). The volume of distribution after an intravenous dose (Vss) is 2.23 L/kg for the racemate in healthy adult volunteers.

    Clearance

    The apparent mean systemic clearance after an oral dose is 10.2 and 10.5 L/h/kg in children and adults, respectively for a 0.3 mg/kg dose, and 0.565 L/h/kg after an intravenous dose of the racemate in healthy adult volunteers.

    Methylphenidate HCl Oral Solution is readily absorbed. Following oral administration of Methylphenidate HCl Oral Solution, peak plasma methylphenidate concentrations are achieved at 1 to 2 hours.

    NIH; DailyMed. Current Medication Information for METHYLPHENIDATE HCL ORAL SOLUTION- methylphenidate hydrochloride solution (Revised: May 2015). Available from, as of November 24, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b372d74-7ba7-437a-be8c-6e8335b78818

    Methylphenidate is readily absorbed after oral administration and reaches peak concentrations in plasma in about 2 hr.

    Brunton, L. Chabner, B, Knollman, B. Goodman and Gillman's The Pharmaceutical Basis of Therapeutics, Twelth Edition, McGraw Hill Medical, New York, NY. 2011, p. 299

    Men received 0.15 or 0.3 mg/kg of methylphenidate orally, and methylphenidate and ritalinic acid, a metabolite, were analyzed in plasma samples obtained at various times after treatment. Maximal methylphenidate concentrations in plasma were found to occur 2.2 hours after administration of either dose. The mean maximal concentration in plasma for methylphenidate was 3.5 ng/mL after 0.15 mg/kg, and 7.8 ng/mL after 0.3 mg/kg. Methylphenidate clearances were high (10.1 L/hour/kg) and variable (range: 3.6-23.2) for the 0.3 mg/kg dose. Pharmacokinetic parameters for children receiving 0.3 mg/kg were essentially the same as for the adults. Ritalinic acid plasma levels were 50-100 times greater than methylphenidate levels in normal adults. The clearance of ritalinic acid is less than that of methylphenidate. When admin to the rat, the absolute bioavailability of methylphenidate was found to be 0.19 in the rat and 0.22 in the monkey, suggesting substantial presystemic elimination of methylphenidate.

    PMID:6410043 WARGIN W ET AL; J PHARMACOL EXP THER 226 (2): 382-6 (1983)

    Neuroanatomical distribution of (14)C-labeled methylphenidate was examined in rabbit brain following intracerebroventricular administration at 15, 60, and 180 minutes after the injection. The highest levels were observed at the 1st sampling time (15 minutes) in medulla and cervical spinal cord. The pons, caudate, tegmentum, and hypothalamus also showed significant uptake of (14)C-methylphenidate.

    SHAH NS ET AL; PROG NEURO-PSYCHOPHARMACOL BIOL PSYCHIATRY 7 (1): 101-6 (1983)

    For more Absorption, Distribution and Excretion (Complete) data for METHYLPHENIDATE (7 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Methylphenidate is hepatically metabolized. More specifically, it is rapidly and extensively metabolized by carboxylesterase CES1A1. Via this enzyme, methylphenidate undergoes de-esterification to ritalinic acid (a-phenyl-2-piperidine acetic acid, PPAA), which has little to no pharmacologic activity.

    In humans, methylphenidate is metabolized primarily via deesterification to alpha-phenylpiperidine acetic acid (PPA, ritalinic acid). The metabolite has little or no pharmacologic activity.

    NIH; DailyMed. Current Medication Information for METHYLPHENIDATE HCL ORAL SOLUTION- methylphenidate hydrochloride solution (Revised: May 2015). Available from, as of November 24, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b372d74-7ba7-437a-be8c-6e8335b78818

    5.7 Biological Half-Life

    Concerta: The half-life of methylphenidate in adults following oral administration of Concerta was approximately 3.5 h. Biphentin: Methylphenidate is eliminated from plasma with a mean half-life of 2.4 hours in children and 2.1 hours in adults. Methylphenidate (immediate release): Methylphenidate is eliminated from the plasma with a mean half-life of 2.4 hours in children and 2.1 hours in adults.

    Methylphenidate ... is a racemate; /in plasma/ its more potent (+) enantimoer has a t(1/2) of approximately 6 hr, and the less potent (-) enantiomer has a t(1/2) of approximately 4 hr. Concentrations in the brain exceed those in plasma.

    Brunton, L. Chabner, B, Knollman, B. Goodman and Gillman's The Pharmaceutical Basis of Therapeutics, Twelth Edition, McGraw Hill Medical, New York, NY. 2011, p. 299

    The mean terminal half-life (t1/2) of methylphenidate following administration of 20 mg Methylphenidate HCl Oral Solution (t1/2 = 2.7 hours) is comparable to the mean terminal t1/2 following administration of Ritalin (methylphenidate hydrochloride immediate-release tablets) (t1/2 = 2.8h) in healthy adult volunteers.

    NIH; DailyMed. Current Medication Information for METHYLPHENIDATE HCL ORAL SOLUTION- methylphenidate hydrochloride solution (Revised: May 2015). Available from, as of November 24, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b372d74-7ba7-437a-be8c-6e8335b78818

    5.8 Mechanism of Action

    While its exact mechanism is unclear, methylphenidate (MPH) has been shown to act as a norepinephrine and dopamine reuptake inhibitor (NDRI), thereby increasing the presence of these neurotransmitters in the extraneuronal space and prolonging their action. There is a dose-related effect of psychostimulants on receptor stimulation, where higher doses are shown to increase norepinephrine (NE) and dopamine (DA) efflux throughout the brain which can result in impaired cognition and locomotor-activating effects. In contrast, low doses are found to selectively activate NE and DE neurotransmission within the prefrontal cortex which is an area of the brain thought to play a prominent role in ADHD pathophysiology, thereby improving clinical efficacy and preventing side effects. The lower doses used to treat ADHD are not associated with the locomotor-activating effects associated with higher doses and instead reduce movement, impulsivity, and increase cognitive function including sustained attention and working memory. Methylphenidate's beneficial effects in sustaining attention have also been shown to be mediated by alpha-1 adrenergic receptor activity. Clinical findings have shown that children with ADHD have an abnormality in the dopamine transporter gene (DAT1), the D4 receptor gene (DRD-4), and/or the D2 receptor gene that may be at least partly overcome by the dopaminergic effects of methylphenidate, suggesting a possible mode of action.

    Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

    NIH; DailyMed. Current Medication Information for METHYLPHENIDATE HCL ORAL SOLUTION- methylphenidate hydrochloride solution (Revised: May 2015). Available from, as of November 24, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b372d74-7ba7-437a-be8c-6e8335b78818

    Although the primary mechanism is largely unknown, the effects of methylphenidate appear to be mediated by blockage of the reuptake mechanism of dopaminergic neurons. In children with attention deficit disorder, methylphenidate decreases motor restlessness and enhances the ability to pay attention. In narcolepsy, methylphenidate appears to act at the cerebral cortex and subcortical structures, including the thalamus, to produce CNS stimulation, resulting in increaed motor activity, increased mental alertness, diminished sense of fatigue, brighter spirits, and mild euphoria.

    USP Convention. USPDI - Drug Information for the Health Care Professional. 17th ed. Volume I. Rockville, MD: Convention, Inc., 1997. (Plus Updates)., p. 2010

    Mode of action: Appears to exert most or all of its effect in the CNS by causing release of biogenic amines, especially norepinephrine and dopamine, from storage sites in nerve terminals. It may also slow down catecholamine metabolism by inhibiting monoamine oxidase.

    International Programme on Chemical Safety; Poisons Information Monograph: Methylphenidate Hydrochloride (PIM 344) (1998) Available from, as of October 24, 2005: https://www.inchem.org/pages/pims.html

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    14-Jan-2022
    20-Jan-2026
    KGS
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    Drugs in Development

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    A Trial to Assess How Centanafadine Interacts With Stimulants in the Body

    Details:

    Centanafadine is a small molecule drug, which is currently being evaluated in Phase I clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.


    Lead Product(s): Centanafadine,Methylphenidate,Lisdexamfetamine Dimesylate

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 02, 2026

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    01

    Otsuka Pharmaceutical

    Japan
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    BePharma
    Not Confirmed

    Otsuka Pharmaceutical

    Japan
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    BePharma
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    Lead Product(s) : Centanafadine,Methylphenidate,Lisdexamfetamine Dimesylate

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    A Trial to Assess How Centanafadine Interacts With Stimulants in the Body

    Details : Centanafadine is a small molecule drug, which is currently being evaluated in Phase I clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    January 02, 2026

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    Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia

    Details:

    Methylphenidate is a Controlled Substance drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Alzheimer Disease.


    Lead Product(s): Methylphenidate,Inapplicable

    Therapeutic Area: Neurology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Controlled Substance

    Sponsor: Alzheimer Society of Canada | Sunnybrook Research Institute | Brain Canada

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 12, 2025

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    02

    Sunnybrook Health Sciences Centre

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    Sunnybrook Health Sciences Centre

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    Lead Product(s) : Methylphenidate,Inapplicable

    Therapeutic Area : Neurology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Alzheimer Society of Canada | Sunnybrook Research Institute | Brain Canada

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia

    Details : Methylphenidate is a Controlled Substance drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Alzheimer Disease.

    Product Name : Undisclosed

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    December 12, 2025

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    Aytu BioPharma Announces Approval of the Cotempla XR-ODT(R) Manufacturing Site Transfer Prior Approval Supplement

    Details:

    Cotempla XR-ODT (methylphenidate extended-release orally disintegrating tablets) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.


    Lead Product(s): Methylphenidate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Cotempla

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 26, 2023

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    03

    Aytu BioPharma

    U.S.A
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    BePharma
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    Aytu BioPharma

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Methylphenidate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Aytu BioPharma Announces Approval of the Cotempla XR-ODT(R) Manufacturing Site Transfer Prior Appr...

    Details : Cotempla XR-ODT (methylphenidate extended-release orally disintegrating tablets) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

    Product Name : Cotempla

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    October 26, 2023

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    AWARE: Management of ADHD in Autism Spectrum Disorder

    Details:

    Amphetamine is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.


    Lead Product(s): Amphetamine Sulfate,Methylphenidate

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Miscellaneous

    Sponsor: Patient-Centered Outcomes Research Institute | University of California, Irvine | Holland Bloorview Kids Rehabilitation Hospital | Children's Hospital of Philadelphia | University of Rochester | Nationwide Children’s Hospital | Children's Hospital Medical

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 23, 2023

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    04

    Patient-Centered Outcomes Research Institute

    Country
    arrow
    BePharma
    Not Confirmed

    Patient-Centered Outcomes Research Institute

    Country
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    BePharma
    Not Confirmed
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    Lead Product(s) : Amphetamine Sulfate,Methylphenidate

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Patient-Centered Outcomes Research Institute | University of California, Irvine | Holland Bloorview Kids Rehabilitation Hospital | Children's Hospital of Philadelphia | University of Rochester | Nationwide Children’s Hospital | Children's Hospital Medical

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    AWARE: Management of ADHD in Autism Spectrum Disorder

    Details : Amphetamine is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    June 23, 2023

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    rTMS for Apathy Clinical Trial

    Details:

    Methylphenidate is a Controlled Substance drug candidate, which is currently being evaluated in clinical studies for the treatment of Alzheimer Disease.


    Lead Product(s): Methylphenidate,Inapplicable

    Therapeutic Area: Neurology Brand Name: Undisclosed

    Study Phase: UndisclosedProduct Type: Controlled Substance

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 30, 2022

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    05

    Sunnybrook Health Sciences Centre

    Country
    arrow
    BePharma
    Not Confirmed

    Sunnybrook Health Sciences Centre

    Country
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    BePharma
    Not Confirmed
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    Lead Product(s) : Methylphenidate,Inapplicable

    Therapeutic Area : Neurology

    Highest Development Status : Undisclosed

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    rTMS for Apathy Clinical Trial

    Details : Methylphenidate is a Controlled Substance drug candidate, which is currently being evaluated in clinical studies for the treatment of Alzheimer Disease.

    Product Name : Undisclosed

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    September 30, 2022

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    Adjunctive Methylphenidate ER in Patients With Schizophrenia to Improve Functional and Cognitive Outcomes

    Details:

    Methylphenidate is a Controlled Substance drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Schizophrenia.


    Lead Product(s): Methylphenidate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Controlled Substance

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 10, 2022

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    06

    The Royal Ottawa Mental Health Centre

    Country
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    BePharma
    Not Confirmed

    The Royal Ottawa Mental Health Centre

    Country
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    BePharma
    Not Confirmed
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    Lead Product(s) : Methylphenidate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Adjunctive Methylphenidate ER in Patients With Schizophrenia to Improve Functional and Cognitive O...

    Details : Methylphenidate is a Controlled Substance drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Schizophrenia.

    Product Name : Undisclosed

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    June 10, 2022

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    Assessing Cognitive Performance Among Adults With Attention Disorders Working on Treadmill

    Details:

    Methylphenidate is a Controlled Substance drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.


    Lead Product(s): Methylphenidate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: Phase II/ Phase IIIProduct Type: Controlled Substance

    Sponsor: Maccabi Healthcare Services, Israel

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 16, 2022

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    07

    Ariel University

    Country
    arrow
    BePharma
    Not Confirmed

    Ariel University

    Country
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    BePharma
    Not Confirmed
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    Lead Product(s) : Methylphenidate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase II/ Phase III

    Partner/Sponsor/Collaborator : Maccabi Healthcare Services, Israel

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Assessing Cognitive Performance Among Adults With Attention Disorders Working on Treadmill

    Details : Methylphenidate is a Controlled Substance drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.

    Product Name : Undisclosed

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    February 16, 2022

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    Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children

    Details:

    Methylphenidate is a Controlled Substance drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.


    Lead Product(s): Methylphenidate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Controlled Substance

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 03, 2021

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    08

    Purdue Pharmaceuticals L.P

    U.S.A
    arrow
    BePharma
    Not Confirmed

    Purdue Pharmaceuticals L.P

    U.S.A
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    BePharma
    Not Confirmed
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    Lead Product(s) : Methylphenidate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children

    Details : Methylphenidate is a Controlled Substance drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.

    Product Name : Undisclosed

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    August 03, 2021

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    Evaluation of the Effect Foquest® on Sleep in Children Aged 6-12 With ADHD

    Details:

    Foquest (Methylphenidate) is a Controlled Substance drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.


    Lead Product(s): Methylphenidate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Foquest

    Study Phase: Phase IVProduct Type: Controlled Substance

    Sponsor: Purdue Pharma

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 05, 2021

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    09

    Purdue Pharma

    Canada
    arrow
    BePharma
    Not Confirmed

    Purdue Pharma

    Canada
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    BePharma
    Not Confirmed
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    Lead Product(s) : Methylphenidate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Purdue Pharma

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Evaluation of the Effect Foquest® on Sleep in Children Aged 6-12 With ADHD

    Details : Foquest (Methylphenidate) is a Controlled Substance drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.

    Product Name : Foquest

    Product Type : Controlled Substance

    Upfront Cash : Inapplicable

    February 05, 2021

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    Aytu BioScience and Neos Therapeutics Announce Definitive Merger Agreement

    Details:

    Aytu adds Neos' established, multi-brand ADHD portfolio which includes Adzenys XR-ODT and Cotempla XR-ODT, enhancing Aytu's footprint in pediatrics and expanding its presence in adjacent specialty care segments.


    Lead Product(s): Methylphenidate,Inapplicable

    Therapeutic Area: Psychiatry/Psychology Brand Name: Cotempla XR-ODT

    Study Phase: Approved FDFProduct Type: Controlled Substance

    Sponsor: Aytu BioPharma

    Deal Size: $44.9 million Upfront Cash: Undisclosed

    Deal Type: Merger December 10, 2020

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    10

    Neos Therapeutics

    U.S.A
    arrow
    BePharma
    Not Confirmed

    Neos Therapeutics

    U.S.A
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    BePharma
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    Lead Product(s) : Methylphenidate,Inapplicable

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Aytu BioPharma

    Deal Size : $44.9 million

    Deal Type : Merger

    DEALS_DEV arrow-down

    Aytu BioScience and Neos Therapeutics Announce Definitive Merger Agreement

    Details : Aytu adds Neos' established, multi-brand ADHD portfolio which includes Adzenys XR-ODT and Cotempla XR-ODT, enhancing Aytu's footprint in pediatrics and expanding its presence in adjacent specialty care segments.

    Product Name : Cotempla XR-ODT

    Product Type : Controlled Substance

    Upfront Cash : Undisclosed

    December 10, 2020

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    Only 10 entries up to this point, click to access all click full view read-more
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    01

    ACTAVIS ELIZABETH

    Ireland
    BePharma
    Not Confirmed
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    ACTAVIS ELIZABETH

    Ireland
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    RLD : No

    TE Code :

    METHYLPHENIDATE

    Brand Name : METHYLPHENIDATE

    Dosage Form : TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL

    Dosage Strength : 8.6MG

    Approval Date : 2020-06-19

    Application Number : 210924

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    02

    ACTAVIS ELIZABETH

    Ireland
    BePharma
    Not Confirmed
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    ACTAVIS ELIZABETH

    Ireland
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    BePharma
    Not Confirmed
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    RLD : No

    TE Code :

    METHYLPHENIDATE

    Brand Name : METHYLPHENIDATE

    Dosage Form : TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL

    Dosage Strength : 17.3MG

    Approval Date : 2020-06-19

    Application Number : 210924

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    03

    ACTAVIS ELIZABETH

    Ireland
    BePharma
    Not Confirmed
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    ACTAVIS ELIZABETH

    Ireland
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    BePharma
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    RLD : No

    TE Code :

    METHYLPHENIDATE

    Brand Name : METHYLPHENIDATE

    Dosage Form : TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL

    Dosage Strength : 25.9MG

    Approval Date : 2020-06-19

    Application Number : 210924

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    04

    NEOS THERAPS INC

    U.S.A
    BePharma
    Not Confirmed
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    NEOS THERAPS INC

    U.S.A
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    RLD : Yes

    TE Code :

    METHYLPHENIDATE

    Brand Name : COTEMPLA XR-ODT

    Dosage Form : TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL

    Dosage Strength : 8.6MG

    Approval Date : 2017-06-19

    Application Number : 205489

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    05

    NEOS THERAPS INC

    U.S.A
    BePharma
    Not Confirmed
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    NEOS THERAPS INC

    U.S.A
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    BePharma
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    RLD : Yes

    TE Code :

    METHYLPHENIDATE

    Brand Name : COTEMPLA XR-ODT

    Dosage Form : TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL

    Dosage Strength : 17.3MG

    Approval Date : 2017-06-19

    Application Number : 205489

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    06

    NEOS THERAPS INC

    U.S.A
    BePharma
    Not Confirmed
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    NEOS THERAPS INC

    U.S.A
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    BePharma
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    RLD : Yes

    TE Code :

    METHYLPHENIDATE

    Brand Name : COTEMPLA XR-ODT

    Dosage Form : TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL

    Dosage Strength : 25.9MG

    Approval Date : 2017-06-19

    Application Number : 205489

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    07

    NEOS THERAPS INC

    U.S.A
    BePharma
    Not Confirmed
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    NEOS THERAPS INC

    U.S.A
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    BePharma
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    RLD : Yes

    TE Code :

    METHYLPHENIDATE

    Brand Name : COTEMPLA XR-ODT

    Dosage Form : TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL

    Dosage Strength : 34.6MG

    Approval Date : 2024-08-19

    Application Number : 205489

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    08

    MYLAN TECH VIATRIS

    U.S.A
    BePharma
    Not Confirmed
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    MYLAN TECH VIATRIS

    U.S.A
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    RLD : No

    TE Code : AB

    METHYLPHENIDATE

    Brand Name : METHYLPHENIDATE

    Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

    Dosage Strength : 10MG/9HR (1.1MG/HR)

    Approval Date : 2022-03-14

    Application Number : 206497

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    09

    MYLAN TECH VIATRIS

    U.S.A
    BePharma
    Not Confirmed
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    MYLAN TECH VIATRIS

    U.S.A
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    BePharma
    Not Confirmed
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    RLD : No

    TE Code : AB

    METHYLPHENIDATE

    Brand Name : METHYLPHENIDATE

    Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

    Dosage Strength : 15MG/9HR (1.6MG/HR)

    Approval Date : 2022-03-14

    Application Number : 206497

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    10

    MYLAN TECH VIATRIS

    U.S.A
    BePharma
    Not Confirmed
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    MYLAN TECH VIATRIS

    U.S.A
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    BePharma
    Not Confirmed
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    RLD : No

    TE Code : AB

    METHYLPHENIDATE

    Brand Name : METHYLPHENIDATE

    Dosage Form : FILM, EXTENDED RELEASE;TRANSDERMAL

    Dosage Strength : 20MG/9HR (2.2MG/HR)

    Approval Date : 2022-03-14

    Application Number : 206497

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    01

    Orion Corporation

    Finland
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
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    Regulatory Info : Approved

    Registration Country : Sweden

    Methylphenidate Hydrochloride

    Brand Name : Methylphenidate Orion

    Dosage Form : Tablet

    Dosage Strength : 18mg

    Packaging :

    Approval Date : 18-05-2020

    Application Number : 2.02E+13

    Regulatory Info : Approved

    Registration Country : Sweden

    Fermion Orion Company Banner

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    02

    Orion Corporation

    Finland
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    BePharma
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
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    Regulatory Info : Approved

    Registration Country : Sweden

    Methylphenidate Hydrochloride

    Brand Name : Methylphenidate Orion

    Dosage Form : Tablet

    Dosage Strength : 54mg

    Packaging :

    Approval Date : 18-05-2020

    Application Number : 2.02E+13

    Regulatory Info : Approved

    Registration Country : Sweden

    Fermion Orion Company Banner

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    03

    Orion Corporation

    Finland
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    BePharma
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
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    Regulatory Info : Approved

    Registration Country : Sweden

    Methylphenidate Hydrochloride

    Brand Name : Methylphenidate Orion

    Dosage Form : Tablet

    Dosage Strength : 27mg

    Packaging :

    Approval Date : 06-04-2022

    Application Number : 2.02E+13

    Regulatory Info : Approved

    Registration Country : Sweden

    Fermion Orion Company Banner

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    04

    Orion Corporation

    Finland
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    BePharma
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
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    Regulatory Info : Approved

    Registration Country : Sweden

    Methylphenidate Hydrochloride

    Brand Name : Methylphenidate Orion

    Dosage Form : Tablet

    Dosage Strength : 36mg

    Packaging :

    Approval Date : 06-04-2022

    Application Number : 2.02E+13

    Regulatory Info : Approved

    Registration Country : Sweden

    Fermion Orion Company Banner

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    05

    2Care4 Aps

    Denmark
    BePharma
    Not Confirmed
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    2Care4 Aps

    Denmark
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    BePharma
    Not Confirmed
    • fda
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    Virtual Booth Virtual Booth
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Methylphenidate Hydrochloride

    Brand Name : Equasym Depot

    Dosage Form : Capsule For Inhalation

    Dosage Strength : 40mg

    Packaging :

    Approval Date : 20-12-2017

    Application Number : 2.02E+13

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    06

    Ebb Medical Ab

    Sweden
    BePharma
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    Ebb Medical Ab

    Sweden
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    BePharma
    Not Confirmed
    • fda
    • EDQM
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    Virtual Booth Virtual Booth
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Methylphenidate Hydrochloride

    Brand Name : Methylphenidate Sandoz

    Dosage Form : Tablet

    Dosage Strength : 36mg

    Packaging :

    Approval Date : 26-06-2020

    Application Number : 2.02E+13

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    07

    Janssen-Cilag Ag

    Italy
    BePharma
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    Janssen-Cilag Ag

    Italy
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    BePharma
    Not Confirmed
    • fda
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    Flag Italy
    Virtual Booth Virtual Booth
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    Methylphenidati Hydrochloridum

    Brand Name : Concerta

    Dosage Form : Modified Release Tablet

    Dosage Strength : 27mg

    Packaging :

    Approval Date : 31/07/2003

    Application Number : 56249

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    08

    Medartuum Ab

    Sweden
    BePharma
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    Medartuum Ab

    Sweden
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    BePharma
    Not Confirmed
    • fda
    • EDQM
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    Flag Sweden
    Virtual Booth Virtual Booth
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Methylphenidate Hydrochloride

    Brand Name : Equasym Depot

    Dosage Form : Capsule For Inhalation

    Dosage Strength : 30mg

    Packaging :

    Approval Date : 13-02-2019

    Application Number : 2.02E+13

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    09

    Orifarm Ab

    Denmark
    BePharma
    Not Confirmed
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    Orifarm Ab

    Denmark
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    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Virtual Booth Virtual Booth
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Methylphenidate Hydrochloride

    Brand Name : Ritalina

    Dosage Form : Capsule For Inhalation

    Dosage Strength : 40mg

    Packaging :

    Approval Date : 20-09-2007

    Application Number : 2.01E+13

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    10

    Orifarm Ab

    Denmark
    BePharma
    Not Confirmed
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    Orifarm Ab

    Denmark
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    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Flag Denmark
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : Deregistered

    Registration Country : Sweden

    Methylphenidate Hydrochloride

    Brand Name : Concerta

    Dosage Form : Tablet

    Dosage Strength : 27mg

    Packaging :

    Approval Date : 27-08-2014

    Application Number : 2.01E+13

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    Listed Dossiers

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    01

    Cohance Lifesciences

    India
    arrow
    DCAT Week
    InterContinental NY Barclay
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : India

    Methylphenidate

    Brand Name :

    Dosage Form : Extended Release Pelle...

    Dosage Strength : 11%

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Cohance

    Portfolio PDF

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    01

    Cohance Lifesciences

    India
    arrow
    DCAT Week
    InterContinental NY Barclay
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Packaging :

    Regulatory Info :

    Methylphenidate

    Dosage : Extended Release Pelle...

    Dosage Strength : 11%

    Brand Name :

    Approval Date :

    Application Number :

    Registration Country : India

    Cohance

    Portfolio PDF

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    02

    Strides Pharma Science

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    arrow
    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSynergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : India

    Methylphenidate

    Brand Name : Methylphenidate

    Dosage Form : Capsule

    Dosage Strength : 10MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Strides Pharma Science

    Portfolio PDF

    Product Web Link

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    02

    Strides Pharma Science

    India
    arrow
    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSynergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Packaging :

    Regulatory Info :

    Methylphenidate

    Dosage : Capsule

    Dosage Strength : 10MG

    Brand Name : Methylphenidate

    Approval Date :

    Application Number :

    Registration Country : India

    Strides Pharma Science

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    03

    Strides Pharma Science

    India
    arrow
    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSynergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : India

    Methylphenidate

    Brand Name : Methylphenidate

    Dosage Form : Capsule

    Dosage Strength : 20MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Strides Pharma Science

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    03

    Strides Pharma Science

    India
    arrow
    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSynergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Packaging :

    Regulatory Info :

    Methylphenidate

    Dosage : Capsule

    Dosage Strength : 20MG

    Brand Name : Methylphenidate

    Approval Date :

    Application Number :

    Registration Country : India

    Strides Pharma Science

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    04

    Strides Pharma Science

    India
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    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSynergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : India

    Methylphenidate

    Brand Name : Methylphenidate

    Dosage Form : Capsule

    Dosage Strength : 30MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Strides Pharma Science

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    04

    Strides Pharma Science

    India
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    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSynergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Packaging :

    Regulatory Info :

    Methylphenidate

    Dosage : Capsule

    Dosage Strength : 30MG

    Brand Name : Methylphenidate

    Approval Date :

    Application Number :

    Registration Country : India

    Strides Pharma Science

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    05

    Strides Pharma Science

    India
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    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSynergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : India

    Methylphenidate

    Brand Name : Methylphenidate

    Dosage Form : Capsule

    Dosage Strength : 40MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Strides Pharma Science

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    05

    Strides Pharma Science

    India
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    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSynergice, a Strides Pharma initiative, is a new gen B2B platform for diverse portofolio needs.

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    Virtual Booth Virtual Booth
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    Regulatory Info :

    Methylphenidate

    Dosage : Capsule

    Dosage Strength : 40MG

    Brand Name : Methylphenidate

    Approval Date :

    Application Number :

    Registration Country : India

    Strides Pharma Science

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    06

    DelNova Healthcare LLP

    India
    BePharma
    Not Confirmed
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    DelNova Healthcare LLP

    India
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    BePharma
    Not Confirmed
    • fda
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    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : India

    Methylphenidate

    Brand Name : Concerta

    Dosage Form : Extended Release Table...

    Dosage Strength : 17MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

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    06

    DelNova Healthcare LLP

    India
    BePharma
    Not Confirmed
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    DelNova Healthcare LLP

    India
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    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
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    Packaging :

    Regulatory Info :

    Methylphenidate

    Dosage : Extended Release Table...

    Dosage Strength : 17MG

    Brand Name : Concerta

    Approval Date :

    Application Number :

    Registration Country : India

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    07

    DelNova Healthcare LLP

    India
    BePharma
    Not Confirmed
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    DelNova Healthcare LLP

    India
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    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : India

    Methylphenidate

    Brand Name : Concerta

    Dosage Form : Extended Release Table...

    Dosage Strength : 54MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

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    07

    DelNova Healthcare LLP

    India
    BePharma
    Not Confirmed
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    DelNova Healthcare LLP

    India
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    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag India
    Virtual Booth Virtual Booth
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    Packaging :

    Regulatory Info :

    Methylphenidate

    Dosage : Extended Release Table...

    Dosage Strength : 54MG

    Brand Name : Concerta

    Approval Date :

    Application Number :

    Registration Country : India

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    08

    Grindeks AS

    Latvia
    BePharma
    Not Confirmed
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    Grindeks AS

    Latvia
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    BePharma
    Not Confirmed
    • fda
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    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Latvia

    Methylphenidate

    Brand Name :

    Dosage Form :

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    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Latvia

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    Grindeks AS

    Latvia
    BePharma
    Not Confirmed
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    Grindeks AS

    Latvia
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    BePharma
    Not Confirmed
    • fda
    • EDQM
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
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    09

    Grindeks AS

    Latvia
    BePharma
    Not Confirmed
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    Grindeks AS

    Latvia
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    BePharma
    Not Confirmed
    • fda
    • EDQM
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
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    Registration Country : Latvia

    Methylphenidate

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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Latvia

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    09

    Grindeks AS

    Latvia
    BePharma
    Not Confirmed
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    Grindeks AS

    Latvia
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    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
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    Registration Country : Latvia

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    10

    Grindeks AS

    Latvia
    BePharma
    Not Confirmed
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    Grindeks AS

    Latvia
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    BePharma
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Flag Latvia
    Virtual Booth Virtual Booth
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    Methylphenidate

    Brand Name :

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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Latvia

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    10

    Grindeks AS

    Latvia
    BePharma
    Not Confirmed
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    Grindeks AS

    Latvia
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    Methylphenidate

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    DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - 17.3MG

    USFDA APPLICATION NUMBER - 205489

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    DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - 25.9MG

    USFDA APPLICATION NUMBER - 205489

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    DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - 34.6MG

    USFDA APPLICATION NUMBER - 205489

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    DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - 8.6MG

    USFDA APPLICATION NUMBER - 205489

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    US drug shortages reduce 16% YoY in Q1 2025; CNS drugs, antimicrobials face highest scarcities

    US drug shortages reduce 16% YoY in Q1 2025; CNS drugs, antimicrobials face highest scarcities

    The pharmaceutical industry in the United States continued to grapple with drug shortages during the first quarter (Q1) of 2025. According to the American Society of Health‑System Pharmacists (ASHP), the total number of active shortages stood at 270 as of March 31, 2025 — only slightly below the 277 reported in September 2024, but down 16.4 percent from an all‑time high of 323 reported in Q1 2024.These numbers imply that while dramatic surges in drug shortages may have subsided, underlying vulnerabilities in manufacturing, supply chains, and raw‑material sourcing continue to frustrate efforts towards a durable resolution.A deeper analysis of these drug scarcities reveals that 41 percent of the 270 active shortages first emerged in 2022 or earlier. This implies that many of the current disruptions have become chronic in nature and are exerting pressure on pharmacy operations. View Our Interactive Dashboard on Drug Shortages So Far in 2025 (Free Excel Available)CNS drugs dominate with 49 meds in short supply; antimicrobials face shortage of 39 drugsClass‑specific analysis reveals that central nervous system (CNS) agents remained the most disrupted category, with 49 distinct CNS drugs having faced scarcities during Q1. This group spans anxiolytics (anti-anxiety drugs) such as clonazepam and flurazepam, sedatives like lorazepam and midazolam, and stimulants such as methylphenidate and lisdexamfetamine. These shortages pose two challenges — controlling seizures and managing sedation in acute care settings. After CNS agents, antimicrobials was the second‑largest category, with shortages affecting 39 drugs. Key antibacterial and anti-fungal agents such as cefotaxime sodium powder for injection, clindamycin phosphate, rifampin, and metronidazole find themselves on ASHP’s active‑shortage roster, threatening both routine hospital protocols and emergency sepsis management.Fluids and electrolytes occupied the third spot, with 29 items facing shortage in Q1 2025. Hormone agents, including insulin analogs, ranked fourth with 24 drugs in short supply.Chemotherapy medications rounded out the top five categories, with 23 antineoplastic agents (a broad class of medications used to treat cancer) flagged as actively constrained in Q1 2025. Notable shortages included azacitidine, carboplatin, methotrexate, and streptozocin. View Our Interactive Dashboard on Drug Shortages So Far in 2025 (Free Excel Available) US faces 26 new shortages; Pharmacopeia list warns of 100 vulnerable medicationsThe first quarter saw the emergence of 26 new shortage declarations, emphasizing that even drugs previously deemed reliably sourced can fall into scarcity. The US has been facing a shortage of attention deficit hyperactivity disorder (ADHD) drugs since 2022. The new shortages included ADHD transdermal patch methylphenidate, peginterferon alfa‑2a (Pegasys) used in chronic hepatitis B and C, and bacitracin ophthalmic ointment.The fragility of the pharmaceutical supply chains has been particularly evident in the aftermath of natural disasters. Hurricane Helene’s flooding at Baxter’s Marion, North Carolina, facility deeply affected IV‑solution supply lines. Baxter supplies roughly 60 percent of the US’ IV fluids and the ASHP report listed “hurricane” as the reason behind nine percent of drug shortages, as of January 2025.Regulatory and policy interventions continue to evolve. The US Pharmacopeia’s inaugural Vulnerable Medicines List, launched in 2025, identifies 100 drugs at the highest risk of future shortages, with a particular focus on injectables (comprising 71 percent of the list) and essential hospital care.Antibiotics, medications for pain management and oncology are the other drugs on the list. Although 61 percent of these vulnerable medicines were not in active shortage at the time of listing, their inclusion is intended to galvanize manufacturers and purchasing organizations to bolster inventories.Meanwhile, the Government Accountability Office in the US has called on the Department of Health and Human Services (HHS) to establish a formal coordination mechanism, warning that elimination of the HHS supply‑chain coordinator role in May 2025 risks fragmenting federal response efforts. View Our Interactive Dashboard on Drug Shortages So Far in 2025 (Free Excel Available) Global shortages mirror US patterns; Europe launches monitoring platform Globally, we notice comparable trends. For instance, Europe has rolled out the European Shortages Monitoring Platform (ESMP) this year in order to centralize shortage reporting across member states. Critical‑medicine shortages in the EU — in areas such as oncology, ADHD, and critical care analgesics — mirror US patterns. The European Medicines Agency’s shortage list currently holds 37 human drugs.According to Health Canada’s May 12, 2025 update, its Tier 3 list had 18 drug shortages that are considered to have the greatest impact on Canada’s drug supply and health‑care system. Tier 3 designation is based on medical necessity and minimal availability of alternatives.In hematology and oncology, scarcity of essential drugs like Oncaspar for acute lymphoblastic leukemia, idarubicin and lomustine for leukemias and brain tumors, anagrelide for thrombocythemia, and preservative‑free methotrexate for various malignancies underscore the impact these drug shortages can have on treatment. View Our Interactive Dashboard on Drug Shortages So Far in 2025 (Free Excel Available) Our viewThe global pharma supply chain is dealing with a fresh wave of uncertainties, especially with the likelihood of tariffs on drugs imported into the US. Analysts warn that the proposed pharmaceutical tariffs could exacerbate supply issues.Over 50 percent of drugs used in the US are manufactured abroad. Generic sterile injectable drugs — like chemotherapy medications and IV saline — are particularly vulnerable due to their complex manufacturing processes and low profit margins. Generic drugs (which account for 90 percent of prescriptions filled in the US) could face increased pressure, as many rely on raw materials from China and India. This could result in more severe drug shortages in the future. 
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    Looking for 113-45-1 / Methylphenidate API manufacturers, exporters & distributors?

    Methylphenidate manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Methylphenidate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Methylphenidate manufacturer or Methylphenidate supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Methylphenidate manufacturer or Methylphenidate supplier.

    PharmaCompass also assists you with knowing the Methylphenidate API Price utilized in the formulation of products. Methylphenidate API Price is not always fixed or binding as the Methylphenidate Price is obtained through a variety of data sources. The Methylphenidate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Methylphenidate

    Synonyms

    Methylphenidan, Phenidylate, Calocain, Plimasine, 113-45-1, Concerta

    Cas Number

    113-45-1

    About Methylphenidate

    A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE.

    Methyl 2-phenyl-2-(piperidin-2-yl)acetate Manufacturers

    A Methyl 2-phenyl-2-(piperidin-2-yl)acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methyl 2-phenyl-2-(piperidin-2-yl)acetate, including repackagers and relabelers. The FDA regulates Methyl 2-phenyl-2-(piperidin-2-yl)acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methyl 2-phenyl-2-(piperidin-2-yl)acetate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Methyl 2-phenyl-2-(piperidin-2-yl)acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Methyl 2-phenyl-2-(piperidin-2-yl)acetate Suppliers

    A Methyl 2-phenyl-2-(piperidin-2-yl)acetate supplier is an individual or a company that provides Methyl 2-phenyl-2-(piperidin-2-yl)acetate active pharmaceutical ingredient (API) or Methyl 2-phenyl-2-(piperidin-2-yl)acetate finished formulations upon request. The Methyl 2-phenyl-2-(piperidin-2-yl)acetate suppliers may include Methyl 2-phenyl-2-(piperidin-2-yl)acetate API manufacturers, exporters, distributors and traders.

    click here to find a list of Methyl 2-phenyl-2-(piperidin-2-yl)acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Methyl 2-phenyl-2-(piperidin-2-yl)acetate USDMF

    A Methyl 2-phenyl-2-(piperidin-2-yl)acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Methyl 2-phenyl-2-(piperidin-2-yl)acetate active pharmaceutical ingredient (API) in detail. Different forms of Methyl 2-phenyl-2-(piperidin-2-yl)acetate DMFs exist exist since differing nations have different regulations, such as Methyl 2-phenyl-2-(piperidin-2-yl)acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Methyl 2-phenyl-2-(piperidin-2-yl)acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Methyl 2-phenyl-2-(piperidin-2-yl)acetate USDMF includes data on Methyl 2-phenyl-2-(piperidin-2-yl)acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methyl 2-phenyl-2-(piperidin-2-yl)acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Methyl 2-phenyl-2-(piperidin-2-yl)acetate suppliers with USDMF on PharmaCompass.

    Methyl 2-phenyl-2-(piperidin-2-yl)acetate NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Methyl 2-phenyl-2-(piperidin-2-yl)acetate as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Methyl 2-phenyl-2-(piperidin-2-yl)acetate API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Methyl 2-phenyl-2-(piperidin-2-yl)acetate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Methyl 2-phenyl-2-(piperidin-2-yl)acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Methyl 2-phenyl-2-(piperidin-2-yl)acetate NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Methyl 2-phenyl-2-(piperidin-2-yl)acetate suppliers with NDC on PharmaCompass.

    Methyl 2-phenyl-2-(piperidin-2-yl)acetate GMP

    Methyl 2-phenyl-2-(piperidin-2-yl)acetate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Methyl 2-phenyl-2-(piperidin-2-yl)acetate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Methyl 2-phenyl-2-(piperidin-2-yl)acetate GMP manufacturer or Methyl 2-phenyl-2-(piperidin-2-yl)acetate GMP API supplier for your needs.

    Methyl 2-phenyl-2-(piperidin-2-yl)acetate CoA

    A Methyl 2-phenyl-2-(piperidin-2-yl)acetate CoA (Certificate of Analysis) is a formal document that attests to Methyl 2-phenyl-2-(piperidin-2-yl)acetate's compliance with Methyl 2-phenyl-2-(piperidin-2-yl)acetate specifications and serves as a tool for batch-level quality control.

    Methyl 2-phenyl-2-(piperidin-2-yl)acetate CoA mostly includes findings from lab analyses of a specific batch. For each Methyl 2-phenyl-2-(piperidin-2-yl)acetate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Methyl 2-phenyl-2-(piperidin-2-yl)acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Methyl 2-phenyl-2-(piperidin-2-yl)acetate EP), Methyl 2-phenyl-2-(piperidin-2-yl)acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Methyl 2-phenyl-2-(piperidin-2-yl)acetate USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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