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    Chemistry

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    Also known as: 496775-62-3, Revolade, Promacta, Eltrombopag (olamine), Unii-4u07f515lg, Sb-497115-gr
    Molecular Formula
    C29H36N6O6
    Molecular Weight
    564.6  g/mol
    InChI Key
    DJMJHIKGMVJYCW-UHFFFAOYSA-N
    FDA UNII
    4U07F515LG
    Eltrombopag
    Eltrombopag Olamine is the orally active ethanolamine salt of eltrombopag, a small-molecule, nonpeptide thrombopoietin receptor agonist with megakaryopoiesis-stimulating activity. Eltrombopag binds to and stimulates the transmembrane domain of the platelet thrombopoietin receptor (TPO-R or CD110), a member of the hematopoietin receptor superfamily. Activation of TPO-R leads to the proliferation and differentiation of cells in the megakaryocytic lineage and an increase in platelet production.
    1 2D Structure

    Eltrombopag

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-aminoethanol;3-[3-[[2-(3,4-dimethylphenyl)-5-methyl-3-oxo-1H-pyrazol-4-yl]diazenyl]-2-hydroxyphenyl]benzoic acid
    2.1.2 InChI
    InChI=1S/C25H22N4O4.2C2H7NO/c1-14-10-11-19(12-15(14)2)29-24(31)22(16(3)28-29)27-26-21-9-5-8-20(23(21)30)17-6-4-7-18(13-17)25(32)33;2*3-1-2-4/h4-13,28,30H,1-3H3,(H,32,33);2*4H,1-3H2
    2.1.3 InChI Key
    DJMJHIKGMVJYCW-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=C(C=C(C=C1)N2C(=O)C(=C(N2)C)N=NC3=CC=CC(=C3O)C4=CC(=CC=C4)C(=O)O)C.C(CO)N.C(CO)N
    2.2 Other Identifiers
    2.2.1 UNII
    4U07F515LG
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. (1,1'-biphenyl)-3-carboxylic Acid, 3'-((2z)-(1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene)hydrazino)-2'-hydroxy-

    2. Ddl-701

    3. Eltrombopag

    4. Promacta

    5. Revolade

    6. Sb-497 115

    7. Sb-497-115

    8. Sb497115

    2.3.2 Depositor-Supplied Synonyms

    1. 496775-62-3

    2. Revolade

    3. Promacta

    4. Eltrombopag (olamine)

    5. Unii-4u07f515lg

    6. Sb-497115-gr

    7. Eltrombopag Diethanolamine Salt

    8. 496775-62-3 (olamine)

    9. Eltrombopag (as Olamine)

    10. 4u07f515lg

    11. Sb-497115gr

    12. Eltrombopag Compd With 2-aminoethanol (1:2)

    13. Eltrombopag Diethanolamine Salt;sb-497115gr

    14. (z)-3'-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4h-pyrazol-4-ylidene)hydrazinyl)-2'-hydroxy-[1,1'-biphenyl]-3-carboxyiic Acid;2-aminoethan-1-ol (1:2)

    15. 3'-((2z)-2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4h-pyrazol-4-ylidene)diazanyl)-2'-hydroxybiphenyl-3-carboxylic Acid Compound With 2-aminoethanol (1:2)

    16. Promacta Olamine

    17. Eltrombopagolamine

    18. Eltrombopag Olamine [usan:jan]

    19. Promacta (tn)

    20. Sb 497115gr

    21. Schembl210183

    22. Amy267

    23. Chembl3989691

    24. Schembl16207741

    25. Schembl23458316

    26. Eltrombopag Olamine (jan/usan)

    27. Eltrombopag Olamine [jan]

    28. Eltrombopag Olamine [usan]

    29. Bcp07055

    30. Eltrombopag Olamine [mart.]

    31. Eltrombopag Olamine [who-dd]

    32. Hy-15306a

    33. Mfcd22380664

    34. S2229

    35. Akos025396658

    36. Akos037515856

    37. Ccg-270074

    38. Cs-1566

    39. Sb19102

    40. Eltrombopag Olamine [orange Book]

    41. 2-aminoethan-1-ol Hemi((e)-3'-(2-(2-(3,4-dimethylphenyl)-5-methyl-3-oxo-2,3-dihydro-1h-pyrazol-4-yl)hydrazono)-2'-oxo-2',3'-dihydro-[1,1'-biphenyl]-3-carboxylate)

    42. Ac-26286

    43. Bs-17370

    44. Ft-0773802

    45. D03978

    46. A904098

    47. Q27260489

    48. Eltrombopag Compd With 2-aminoethanol (1:2) [mi]

    49. (1,1'-biphenyl)-3-carboxylic Acid, 3'-((2z)-(1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene)hydrazino)-2'-hydroxy, Compound With 2-aminoethanol (1:2)

    50. (1,1'-biphenyl)-3-carboxylic Acid, 3'-((2z)-(1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene)hydrazino)-2'-hydroxy-, Compound With 2-aminoethanol (1:2)

    51. (1,1'-biphenyl)-3-carboxylic Acid, 3'-(2-(1-(3,4-dimethylphenyl)-4,5-dihydro-3-methyl-5-oxo-1h-pyrazol-4-yl)diazenyl)-2'-hydroxy-, Compd. With 2-aminoethanol (1:2)

    52. 2-aminoethan-1-ol Hemi((z)-3'-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4h-pyrazol-4-ylidene)hydrazinyl)-2'-hydroxy-[1,1'-biphenyl]-3-carboxylate)

    53. 2-aminoethanol (e)-3'-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-pyrazol-4(5h)-ylidene)hydrazinyl)-2'-hydroxy-[1,1'-biphenyl]-3-carboxylate

    54. 2-aminoethanol;3-[3-[[2-(3,4-dimethylphenyl)-5-methyl-3-oxo-1h-pyrazol-4-yl]diazenyl]-2-hydroxyphenyl]benzoic Acid

    55. 3'-[(2z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic Acid Bis-(monoethanolamine)

    56. 3'-[(2z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol4-ylidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic Acid Bis-(monoethanolamine)

    57. 3'-{(2z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4h-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic Acid 2-aminoethanol (1:2)

    2.4 Create Date
    2019-01-15
    3 Chemical and Physical Properties
    Molecular Weight 564.6 g/mol
    Molecular Formula C29H36N6O6
    Hydrogen Bond Donor Count7
    Hydrogen Bond Acceptor Count11
    Rotatable Bond Count7
    Exact Mass564.26963289 g/mol
    Monoisotopic Mass564.26963289 g/mol
    Topological Polar Surface Area207 Ų
    Heavy Atom Count41
    Formal Charge0
    Complexity822
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Indication

    Revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e. g. corticosteroids, immunoglobulins) (see sections 4. 2 and 5. 1).

    Revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e. g. corticosteroids, immunoglobulins) (see sections 4. 2 and 5. 1).

    Revolade is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4. 4 and 5. 1).

    Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5. 1).

    5 Pharmacology and Biochemistry
    5.1 FDA Pharmacological Classification
    5.1.1 Pharmacological Classes
    Increased Megakaryocyte Maturation [PE]; Increased Platelet Production [PE]; Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]; Thrombopoietin Receptor Agonist [EPC]; Thrombopoietin Receptor Agonists [MoA]; UGT1A1 Inhibitors [MoA]; UGT1A3 Inhibitors [MoA]; UGT1A4 Inhibitors [MoA]; UGT1A6 Inhibitors [MoA]; UGT1A9 Inhibitors [MoA]; UGT2B15 Inhibitors [MoA]; UGT2B7 Inhibitors [MoA]; Breast Cancer Resistance Protein Inhibitors [MoA]
    5.2 ATC Code

    B02BX05

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    11-Jan-2022
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    DOSAGE - TABLET;ORAL - EQ 100MG ACID **Federa...DOSAGE - TABLET;ORAL - EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 22291

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    DOSAGE - TABLET;ORAL - EQ 12.5MG ACID

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    DOSAGE - TABLET;ORAL - EQ 25MG ACID

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    DOSAGE - TABLET;ORAL - EQ 75MG ACID

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    DATA COMPILATION #PharmaFlow

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    FDA’s first generic approvals slump 21% in 2024; Novartis’ top seller Entresto, cancer blockbuster Tasigna lead 2024 patent cliff

    FDA’s first generic approvals slump 21% in 2024; Novartis’ top seller Entresto, cancer blockbuster Tasigna lead 2024 patent cliff

    A watershed moment in the journey of a drug is when it transitions from being a patented, high‐priced innovator product to an affordable generic.Through an inaugural approval, or a “first generic”,  the US Food Drug Administration (FDA) permits a manufacturer to market a generic version of a brand‐name drug — a process that, when successful, grants 180 days of exclusivity to the generic sponsor. This exclusivity is especially valuable when the drug in question is a blockbuster.In FDA’s fiscal year 2024 (i.e. from October 1, 2023 to September 30, 2024), the number of first-time generic drug approvals decreased by 21.3 percent — from 89 in FY 2023 to 70 in FY 2024, the lowest in at least nine years.Lupin emerged as a frontrunner in first generics, increasing its approvals from three in FY 2023 to seven in FY 2024, Apotex and Zydus Lifesciences from four to six, and Dr. Reddy’s from two to four. In contrast, Teva, Amneal, and Sun Pharma experienced a decline.Overall, neurology led the way with 10 approvals, while immunology saw eight, including three approvals in dermatology. Oncology and cardiology/vascular disease saw six approvals each. Ophthalmology saw five while psychiatry, and infectious diseases each contributed four approvals. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Novartis’ top seller Entresto, blockbuster Tasigna among six key drugs hit by generic rivalsIn 2024, the tide turned sharply for Novartis as it lost exclusivity for six of its drugs. Among them was its blockbuster Entresto, that has generated US$ 29.2 billion in revenue so far, including US$ 7.8 billion in 2024.A combination of sacubitril and valsartan, Entresto has transformed heart failure management. Entresto was the primary driver of Novartis’ sales growth last year. It was also one of the 10 drugs selected by the Biden administration in 2023 for Medicare price negotiations. Novartis has been fighting a fierce legal battle to protect Entresto from generic competition. In 2024, Entresto’s generic saga reached a crescendo. Alembic Pharmaceuticals, Laurus Labs, and Crystal Pharmaceutical’s generic versions of Entresto received FDA approval in May last year. But the Swiss drugmaker has noted that as of January 2025, there were no Entresto generics available in the US.Novartis’ Tasigna (nilotinib) has been a cornerstone in the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Apotex won approvals for generics of 50 mg, 150 mg, and 200 mg of nilotinib formulations, thereby offering a more affordable option for both adult and pediatric patients. Owing to the generics, Tasigna’s sales fell 10 percent in 2024.Novartis’ Mekinist (trametinib), Votrient (pazopanib), Rydapt (midostaurin), and Promacta (eltrombopag) have long been critical treatments in oncology and hematology. With generic competition hitting these key assets, Novartis is now aggressively forging deals to strengthen its pipeline. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  FDA clears first generics for Neurocrine’s Ingrezza, Supernus’s Gocovri, ALS drugsIn psychiatry, Neurocrine Biosciences’ Ingrezza (valbenazine) capsules have carved out a niche for themselves as a first-in-class treatment for tardive dyskinesia, a movement disorder that can develop as a side effect of long-term use of antipsychotic meds. Two generics for Ingrezza from India’s Zydus and Lupin bagged FDA approval, as Ingrezza sales topped US$ 2.3 billion last year.Zydus also won first generic approval for Supernus Pharmaceuticals’ Gocovri (amantadine) extended-release capsules, which is a treatment of dyskinesia in Parkinson’s disease patients receiving levodopa-based therapy.Four companies received FDA approvals for their first generics of Mitsubishi Tanabe’s patented drug Radicava (edaravone). These are Dr. Reddy’s Laboratories, Gland Pharma (a Fosun Pharmaceutical subsidiary), Hikma and Long Grove. Radicava is a drug that treats amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. Another treatment for ALS from Italfarmaco — Tiglutik (riluzole) — received a first generic when FDA okayed Alkem Laboratories riluzole oral suspension. The med helps slow disease progression. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Pfizer’s Ibrance, Gilead’s Descovy, Lilly’s Olumiant treatment come under generic pressureIn oncology, Synthon Pharmaceuticals launched its generic version of Pfizer’s Ibrance (palbociclib) tablets. Generating sales of US$ 4.4 billion in 2024, this groundbreaking CDK4/6 inhibitor is Pfizer’s best-selling cancer drug. It has transformed treatment for hormone receptor-positive, HER2-negative advanced breast cancer by halting cancer cell division and significantly extending progression-free survival when combined with endocrine therapy.Descovy, a combination of emtricitabine and tenofovir alafenamide, stands as one of the most important therapies in the fight against HIV infection and related conditions. Originally developed by Gilead Sciences, Descovy has played a pivotal role in modern antiretroviral therapy, contributing US$ 2.1 billion to Gilead’s revenue in 2024. Apotex’s first generic approval for Descovy marked its second copycat for a blockbuster drug in 2024. The other generic approval it got its hands on was for Boehringer Ingelheim’s Pradaxa (dabigatran etexilate), a blood thinner that posted sales of € 845 million (US$ 883 million) in 2023.In immunology, Eli Lilly’s Olumiant (baricitinib) has emerged as an important therapy for treating inflammatory conditions such as rheumatoid arthritis. Aurobindo Pharma bagged FDA approval for generic baricitinib tablets.Ipsen’s Somatuline Depot (lanreotide) injection, a treatment for neuroendocrine tumors and endocrine disorders that generated about € 1.07 billion (US$1.1 billion) in 2023 sales, also has a generic now, with Cipla’s subsidiary InvaGen Pharmaceuticals receiving an FDA approval. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available) FDA okays copycats for opioid withdrawal med Lucemyra, weight loss drug Qsymia, contraceptive SlyndFDA also demonstrated a focused commitment to addressing two of the nation’s biggest public health concerns — the opioid crisis and obesity. Lucemyra (lofexidine), originally developed by US WorldMeds, is a non-opioid medication indicated for mitigating symptoms associated with acute opioid withdrawal and facilitating the completion of opioid discontinuation treatment. The introduction of Indoco Remedies’ generic version is poised to expand access to this critical therapy by offering a cost-effective alternative for managing substance use disorders.Vivus’ Qsymia (phentermine/topiramate), a chronic weight management therapy, also received a first generic. Actavis’ generic for Qsymia provides a more accessible option to patients striving to lose weight. Actavis is a subsidiary of Teva.FDA also approved Lupin’s first generic version of Insud Pharma’s Slynd—a progestin‑only contraceptive containing 4 mg drospirenone for use by females of reproductive potential to prevent pregnancy. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Our viewOver the next two years, several blockbusters such as Novo Nordisk’s Ozempic (semaglutide), AstraZeneca’s Farxiga (dapagliflozin), Bristol Myers Squibb’s Revlimid (lenalidomide) and its Pfizer partnered drug Eliquis (apixaban) stand to lose their patent protection. We expect more patent litigations and some exciting innovations in the generics space.
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    NEWS #PharmaBuzz

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    01

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    Eltrombopag Olamine

    Drug Cost (USD) : 557,676,106

    Year : 2023

    Prescribers : 5708

    Prescriptions : 39505

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    Company : Novartis

    Eltrombopag Olamine

    Drug Cost (USD) : 454,825,188

    Year : 2022

    Prescribers : 5150

    Prescriptions : 35692

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    Company : Novartis

    Eltrombopag Olamine

    Drug Cost (USD) : 389,486,269

    Year : 2021

    Prescribers : 4960

    Prescriptions : 32978

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    04

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    Switzerland
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    Brand Name : Promacta

    Switzerland
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    Company : Novartis

    Eltrombopag Olamine

    Drug Cost (USD) : 341,789,027

    Year : 2020

    Prescribers : 4616

    Prescriptions : 31379

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    05

    Brand Name : Promacta

    Switzerland
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    Brand Name : Promacta

    Switzerland
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    Company : Novartis

    Eltrombopag Olamine

    Drug Cost (USD) : 304,352,153

    Year : 2019

    Prescribers : 4977

    Prescriptions : 31057

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    06

    Brand Name : Promacta

    United Kingdom
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    United Kingdom
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    Company : Glaxosmithkline

    Eltrombopag Olamine

    Drug Cost (USD) : 424,909

    Year : 2018

    Prescribers : 35

    Prescriptions : 72

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    07

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    Switzerland
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    Switzerland
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    Company : Novartis

    Eltrombopag Olamine

    Drug Cost (USD) : 254,107,970

    Year : 2018

    Prescribers : 4752

    Prescriptions : 29029

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    08

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    United Kingdom
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    Company : Glaxosmithkline

    Eltrombopag Olamine

    Drug Cost (USD) : 2,376,341

    Year : 2017

    Prescribers : 179

    Prescriptions : 413

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    09

    Brand Name : Promacta

    Switzerland
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    Company : Novartis

    Eltrombopag Olamine

    Drug Cost (USD) : 189,364,721

    Year : 2017

    Prescribers : 3911

    Prescriptions : 24061

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    10

    Brand Name : Promacta

    United Kingdom
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    Company : Glaxosmithkline

    Eltrombopag Olamine

    Drug Cost (USD) : 51,113,943

    Year : 2016

    Prescribers : 2229

    Prescriptions : 8487

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    Regulatory FDF Prices

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    01

    Brand Name : Revolade

    Switzerland
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    Brand Name : Revolade

    Switzerland
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    AGGSpend
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    Novartis Pharma Schweiz AG

    Eltrombopag

    Dosage Form : Filmtabl

    Dosage Strength : 75mg

    Price Per Pack (Euro) : 2993.81

    Published in :

    Country : Switzerland

    RX/OTC/DISCN : Class A

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    Brand Name : Revolade

    Switzerland
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    AGGSpend
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    Brand Name : Revolade

    Switzerland
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    AGGSpend
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    Novartis Pharma Schweiz AG

    Eltrombopag

    Dosage Form : Filmtable

    Dosage Strength : 25mg

    Price Per Pack (Euro) : 498.97

    Published in :

    Country : Switzerland

    RX/OTC/DISCN : Class A

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    03

    Brand Name : Revolade

    Switzerland
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    AGGSpend
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    Brand Name : Revolade

    Switzerland
    arrow
    AGGSpend
    Not Confirmed

    Novartis Pharma Schweiz AG

    Eltrombopag

    Dosage Form : Filmtable

    Dosage Strength : 25mg

    Price Per Pack (Euro) : 997.94

    Published in :

    Country : Switzerland

    RX/OTC/DISCN : Class A

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    04

    Brand Name : Revolade

    Switzerland
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    AGGSpend
    Not Confirmed

    Brand Name : Revolade

    Switzerland
    arrow
    AGGSpend
    Not Confirmed

    Novartis Pharma Schweiz AG

    Eltrombopag

    Dosage Form : Filmtable

    Dosage Strength : 50mg

    Price Per Pack (Euro) : 997.94

    Published in :

    Country : Switzerland

    RX/OTC/DISCN : Class A

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    05

    Brand Name : Revolade

    Switzerland
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    AGGSpend
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    Brand Name : Revolade

    Switzerland
    arrow
    AGGSpend
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    Novartis Pharma Schweiz AG

    Eltrombopag

    Dosage Form : Filmtable

    Dosage Strength : 50mg

    Price Per Pack (Euro) : 1995.87

    Published in :

    Country : Switzerland

    RX/OTC/DISCN : Class A

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    06

    Brand Name : Revolade

    Switzerland
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    AGGSpend
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    Brand Name : Revolade

    Switzerland
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    AGGSpend
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    Novartis Pharma Schweiz AG

    Eltrombopag

    Dosage Form : Filmtable

    Dosage Strength : 12.5mg

    Price Per Pack (Euro) : 249.49

    Published in :

    Country : Switzerland

    RX/OTC/DISCN : Class A

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    Annual Reports

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    01

    Brand Name : Promacta/Revolade

    Eltrombopag Olamine

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    Brand Name : Promacta/Revolade

    Switzerland
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    Novartis

    Eltrombopag Olamine

    Main Therapeutic Indication : Oncology

    Currency : USD

    2020 Revenue in Millions : 1,738

    2019 Revenue in Millions : 1,416

    Growth (%) : 23

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    02

    Brand Name : Promacta/Revolade

    Eltrombopag

    arrow
    AGGSpend
    Not Confirmed

    Brand Name : Promacta/Revolade

    Switzerland
    arrow
    AGGSpend
    Not Confirmed

    Novartis

    Eltrombopag

    Main Therapeutic Indication : Oncology

    Currency : USD

    2020 Revenue in Millions : 1,738

    2019 Revenue in Millions : 1,416

    Growth (%) : 23

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    03

    Brand Name : Promacta/Revolade

    Eltrombopag

    arrow
    AGGSpend
    Not Confirmed

    Brand Name : Promacta/Revolade

    Switzerland
    arrow
    AGGSpend
    Not Confirmed

    Novartis

    Eltrombopag

    Main Therapeutic Indication : Oncology

    Currency : USD

    2021 Revenue in Millions : 2,016

    2020 Revenue in Millions : 1,738

    Growth (%) : 16

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    04

    Brand Name : Promacta/Revolade

    Eltrombopag Olamine

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    AGGSpend
    Not Confirmed

    Brand Name : Promacta/Revolade

    Switzerland
    arrow
    AGGSpend
    Not Confirmed

    Novartis

    Eltrombopag Olamine

    Main Therapeutic Indication : Oncology

    Currency : USD

    2021 Revenue in Millions : 2,016

    2020 Revenue in Millions : 1,738

    Growth (%) : 16

    blank

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    05

    Brand Name : Promacta/Revolade

    Eltrombopag

    arrow
    AGGSpend
    Not Confirmed

    Brand Name : Promacta/Revolade

    Switzerland
    arrow
    AGGSpend
    Not Confirmed

    Novartis

    Eltrombopag

    Main Therapeutic Indication : Hematology

    Currency : USD

    2022 Revenue in Millions : 2,088

    2021 Revenue in Millions : 2,016

    Growth (%) : 4

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    06

    Brand Name : Promacta/Revolade

    Eltrombopag Olamine

    arrow
    AGGSpend
    Not Confirmed

    Brand Name : Promacta/Revolade

    Switzerland
    arrow
    AGGSpend
    Not Confirmed

    Novartis

    Eltrombopag Olamine

    Main Therapeutic Indication : Hematology

    Currency : USD

    2022 Revenue in Millions : 2,088

    2021 Revenue in Millions : 2,016

    Growth (%) : 4

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    07

    Brand Name : Promacta/Revolade

    Eltrombopag Olamine

    arrow
    AGGSpend
    Not Confirmed

    Brand Name : Promacta/Revolade

    Switzerland
    arrow
    AGGSpend
    Not Confirmed

    Novartis

    Eltrombopag Olamine

    Main Therapeutic Indication : Oncology

    Currency : USD

    2023 Revenue in Millions : 2,269

    2022 Revenue in Millions : 2,088

    Growth (%) : 9

    blank

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    08

    Brand Name : Promacta/Revolade

    Eltrombopag

    arrow
    AGGSpend
    Not Confirmed

    Brand Name : Promacta/Revolade

    Switzerland
    arrow
    AGGSpend
    Not Confirmed

    Novartis

    Eltrombopag

    Main Therapeutic Indication : Oncology

    Currency : USD

    2023 Revenue in Millions : 2,269

    2022 Revenue in Millions : 2,088

    Growth (%) : 9

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    09

    Brand Name : Promacta/Revolade

    Eltrombopag Olamine/Eltrombopag

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    AGGSpend
    Not Confirmed

    Brand Name : Promacta/Revolade

    Switzerland
    arrow
    AGGSpend
    Not Confirmed

    Novartis

    Eltrombopag Olamine/Eltrombopag

    Main Therapeutic Indication : Oncology

    Currency : USD

    2024 Revenue in Millions : 2,216

    2023 Revenue in Millions : 2,269

    Growth (%) : -2

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    10

    Brand Name : Promacta

    EltroMbopag diethanolaMine salt

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    Brand Name : Promacta

    United Kingdom
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    AGGSpend
    Not Confirmed

    GlaxoSmithKline

    EltroMbopag diethanolaMine salt

    Main Therapeutic Indication : Oncology

    Currency : USD

    2014 Revenue in Millions : 24.20%

    2013 Revenue in Millions :

    Growth (%) :

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    Market Place

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    APIs

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    VietNam.png
    Oral grade Eltrombopag Olamine API needed in Vietnam [ENA20223]
    A company that focuses on manufacturing and distribution of pharmaceutical products, medicinal herbs and medical equipment is looking for suppliers of Oral grade Eltrombopag Olamine API for commercial purposes. The required quantity is 250 g, 500 g, 1 kg, 2 kg & 5 kg. The suppliers must support this enquiry with DMF, GMP & CoA.
    09 Aug 2024

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    09 Aug 2024

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    09 Aug 2024

    Oman.png
    USP/ Ph. Eur. Grade Eltrombopag Olamine API needed in Oman [ENA19636]
    A company that focuses on manufacturing and development of various finished formulation including oral solid, oral liquid & topical dosage forms is looking for suppliers of USP/ Ph. Eur. Grade Eltrombopag Olamine API for both development & commercial purposes. The required quantity 73 g for first year, 378 g for second year, 1.2 kg for third year, 1.5 kg for fourth year, 1.8 kg for fifth year, 2.2 kg for sixth year, 2.6 kg for seventh year & 2 kg for eighth year. The suppliers must support this enquiry with USDMF/ CEP, GMP & CoA.
    04 Jun 2024

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    04 Jun 2024

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    Reply Comment (8)

    04 Jun 2024

    india-flag.png
    Eltrombopag Olamine API needed in India [ENA19603]
    A CRO that provides formulation and analytical development services for OSDs, parenteral and liquid orals is looking for suppliers of Eltrombopag Olamine API. The required quantity is 1 kg for development and 30 kg for commercial purposes. The suppliers must support this enquiry with ODMF & CoA.
    29 May 2024

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    29 May 2024

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    Reply Comment (2)

    29 May 2024

    india-flag.png
    Various APIs needed in India [ENA15174]
    A company that focuses on the manufacturing of pharmaceuticals is looking for suppliers of Various APIs. The suppliers must support this enquiry with CoA. 1. Asenapine API 2. Axitinib API 3. Fesoterodine Fumarate API 4. Eltrombopag Olamine API
    30 Sep 2022

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    30 Sep 2022

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    Reply Comment (4)

    30 Sep 2022

    Kazakhstan.png
    Various APIs needed in Kazakhstan [ENA14980]
    A company that deals in various pharmaceutical products is looking for suppliers of Various APIs for commercial purpose. The suppliers must support this enquiry with CoA. 1. Ramipril (MOQ) API 2. Irbesartan (1.5 MT/ annum) API 3. Telmisartan (1.3 MT/ annum) API 4. Sacubitril + Valsartan (1.5 MT/ annum) API 5. Eltrombopag Olamine (80 kg/ annum) API 6. Telmisartan Granules SD & DC (MOQ) API 7. Meglumine (MOQ) API
    09 Sep 2022

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    09 Sep 2022

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    Reply Comment (16)

    09 Sep 2022

    Canada.png
    Eltrombopag (20 kg/ annum) API needed in Canada [ENA14362]
    A CDMO that specializes in complex oral solid dose, liquids, semi-solids and nasal sprays for pharmaceutical Rx and OTC products is looking for suppliers of Eltrombopag (20 kg/ annum) API for commercial purpose. The suppliers must support this enquiry with USDMF.
    15 Jul 2022

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    15 Jul 2022

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    Reply Comment (7)

    15 Jul 2022

    Bangladesh.png
    Various APIs needed in Bangladesh [ENA13624]
    A company that deals in various pharmaceutical products is looking for suppliers of Various APIs for commercial purpose. The suppliers must support this enquiry with CoA. 1. Pilocarpine (5 kg) API 2. Eltrombopag (2 kg) API
    13 May 2022

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    13 May 2022

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    Reply Comment (3)

    13 May 2022

    Bangladesh.png
    Eltrombopag Olamine API needed in Bangladesh [ENA13597]
    A company that deals in various pharmaceutical products is looking for suppliers of Eltrombopag Olamine API for commercial purpose. The suppliers must support this enquiry with CoA.
    10 May 2022

    Reply

    10 May 2022

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    Reply Comment (10)

    10 May 2022

    Egypt.png
    Various APIs needed in Egypt [ENA10114]
    A company that deals in various pharmaceutical products including hard gelatin capsules, tablets and dietary supplements is looking for suppliers of Various APIs for commercial purposes. The required quantity is MOQ for each. The suppliers must support this enquiry with CoA and GMP. 1. Betamethasone Sodium Phosphate API 2. Sterile Cyanocobalamin API 3. Ondansetron HCl API 4. Olsalazine API 5. Folic Acid API 6. Sodium Bicarbonate API 7. Orotic Acid API 8. Ceftolozane Sulfate API 9. Etoricoxib API 10. Thiamine API 11. Ascorbic Acid API 12. Eucalyptus Oil API 13. Eltrombopag Olamine API 14. Nicotinamide API 15. Benfotiamine API 16. Pyridoxine HCl API
    03 Apr 2021

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    03 Apr 2021

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    Reply Comment (13)

    03 Apr 2021

    VietNam.png
    Various APIs needed in Vietnam [ENA09884]
    One of the fastest growing organizations in the pharmaceutical industry is looking for suppliers of Various APIs for commercial manufacturing purposes. The suppliers must support this enquiry with GMP and DMF. 1. Apixaban (3 kg) API 2. Bupropion (25 kg) API 3. Canagliflozin (50 kg) API 4. Cyclobenzaprine HCl (10 kg) API 5. Eltrombopag Olamine (10 kg) API 6. Empagliflozin (10 kg) API 7. Lenalidomid (5 kg) API 8. Posaconazole (5 kg) API 9. Prasugrel (5 kg) API 10. Trazodone (20 kg) API
    06 Mar 2021

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    06 Mar 2021

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    Reply Comment (16)

    06 Mar 2021

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

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    US Patents

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    01

    TEVA PHARMS INC

    ELTROMBOPAG CHOLINE

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    TEVA PHARMS INC

    Israel
    arrow
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    Patent Expiration Date : 2038-11-05

    ELTROMBOPAG CHOLINE

    US Patent Number : 11072586

    Drug Substance Claim : Y

    Drug Product Claim : Y

    Application Number : 216774

    Patent Use Code : U-3937

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2038-11-05

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    TEVA PHARMS INC

    ELTROMBOPAG CHOLINE

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    Not Confirmed

    TEVA PHARMS INC

    Israel
    arrow
    AGGSpend
    Not Confirmed

    Patent Expiration Date : 2038-11-05

    ELTROMBOPAG CHOLINE

    US Patent Number : 11072586

    Drug Substance Claim : Y

    Drug Product Claim : Y

    Application Number : 216774

    Patent Use Code : U-3937

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2038-11-05

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    03

    NOVARTIS

    ELTROMBOPAG OLAMINE

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    NOVARTIS

    Switzerland
    arrow
    AGGSpend
    Not Confirmed

    Patent Expiration Date : 2028-02-01

    ELTROMBOPAG OLAMINE

    US Patent Number : 8052993*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 22291

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2028-02-01

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    04

    NOVARTIS

    ELTROMBOPAG OLAMINE

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    NOVARTIS

    Switzerland
    arrow
    AGGSpend
    Not Confirmed

    Patent Expiration Date : 2027-08-01

    ELTROMBOPAG OLAMINE

    US Patent Number : 8062665

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 22291

    Patent Use Code : U-1714

    Delist Requested :

    Patent Use Description : TREATMENT OF THROMBOCY...

    Patent Expiration Date : 2027-08-01

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    05

    NOVARTIS

    ELTROMBOPAG OLAMINE

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    NOVARTIS

    Switzerland
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    AGGSpend
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    Patent Expiration Date : 2028-02-01

    ELTROMBOPAG OLAMINE

    US Patent Number : 8828430*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 22291

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2028-02-01

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        ABOUT THIS PAGE

        Looking for 496775-62-3 / Eltrombopag API manufacturers, exporters & distributors?

        Eltrombopag manufacturers, exporters & distributors 1

        69

        PharmaCompass offers a list of Eltrombopag 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 Eltrombopag manufacturer or Eltrombopag supplier for your needs.

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

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

        API | Excipient name

        Eltrombopag

        Synonyms

        496775-62-3, Revolade, Promacta, Eltrombopag (olamine), Unii-4u07f515lg, Sb-497115-gr

        Cas Number

        496775-62-3

        Unique Ingredient Identifier (UNII)

        4U07F515LG

        About Eltrombopag

        Eltrombopag Olamine is the orally active ethanolamine salt of eltrombopag, a small-molecule, nonpeptide thrombopoietin receptor agonist with megakaryopoiesis-stimulating activity. Eltrombopag binds to and stimulates the transmembrane domain of the platelet thrombopoietin receptor (TPO-R or CD110), a member of the hematopoietin receptor superfamily. Activation of TPO-R leads to the proliferation and differentiation of cells in the megakaryocytic lineage and an increase in platelet production.

        Eltrombopag Manufacturers

        A Eltrombopag manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eltrombopag, including repackagers and relabelers. The FDA regulates Eltrombopag manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eltrombopag 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 Eltrombopag manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

        Eltrombopag Suppliers

        A Eltrombopag supplier is an individual or a company that provides Eltrombopag active pharmaceutical ingredient (API) or Eltrombopag finished formulations upon request. The Eltrombopag suppliers may include Eltrombopag API manufacturers, exporters, distributors and traders.

        click here to find a list of Eltrombopag suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

        Eltrombopag USDMF

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

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

        click here to find a list of Eltrombopag suppliers with USDMF on PharmaCompass.

        Eltrombopag JDMF

        The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

        The Eltrombopag Drug Master File in Japan (Eltrombopag JDMF) empowers Eltrombopag API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

        PMDA reviews the Eltrombopag JDMF during the approval evaluation for pharmaceutical products. At the time of Eltrombopag JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

        click here to find a list of Eltrombopag suppliers with JDMF on PharmaCompass.

        Eltrombopag KDMF

        In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

        Pharmaceutical companies submit a Eltrombopag Drug Master File in Korea (Eltrombopag KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eltrombopag. The MFDS reviews the Eltrombopag KDMF as part of the drug registration process and uses the information provided in the Eltrombopag KDMF to evaluate the safety and efficacy of the drug.

        After submitting a Eltrombopag KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Eltrombopag API can apply through the Korea Drug Master File (KDMF).

        click here to find a list of Eltrombopag suppliers with KDMF on PharmaCompass.

        Eltrombopag WC

        A Eltrombopag written confirmation (Eltrombopag WC) is an official document issued by a regulatory agency to a Eltrombopag manufacturer, verifying that the manufacturing facility of a Eltrombopag active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Eltrombopag APIs or Eltrombopag finished pharmaceutical products to another nation, regulatory agencies frequently require a Eltrombopag WC (written confirmation) as part of the regulatory process.

        click here to find a list of Eltrombopag suppliers with Written Confirmation (WC) on PharmaCompass.

        Eltrombopag 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 Eltrombopag as an active pharmaceutical ingredient (API).

        Finished drug products

        The FDA updates the NDC directory daily. The NDC numbers for Eltrombopag 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 Eltrombopag 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 Eltrombopag and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Eltrombopag NDC to their finished compounded human drug products, they may choose to do so.

        click here to find a list of Eltrombopag suppliers with NDC on PharmaCompass.

        Eltrombopag GMP

        Eltrombopag 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 Eltrombopag 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 Eltrombopag GMP manufacturer or Eltrombopag GMP API supplier for your needs.

        Eltrombopag CoA

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

        Eltrombopag CoA mostly includes findings from lab analyses of a specific batch. For each Eltrombopag 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.

        Eltrombopag may be tested according to a variety of international standards, such as European Pharmacopoeia (Eltrombopag EP), Eltrombopag JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eltrombopag 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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