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Chemistry

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Also known as: 35604-67-2, 2-((2-ethoxyphenoxy)methyl)morpholine hydrochloride, Viloxazine hcl, Vivalan, Emovit, Vicilan
Molecular Formula
C13H20ClNO3
Molecular Weight
273.75  g/mol
InChI Key
HJOCKFVCMLCPTP-UHFFFAOYSA-N
FDA UNII
OQW30I1332

Viloxazine Hydrochloride
A morpholine derivative used as an antidepressant. It is similar in action to IMIPRAMINE.
1 2D Structure

Viloxazine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[(2-ethoxyphenoxy)methyl]morpholine;hydrochloride
2.1.2 InChI
InChI=1S/C13H19NO3.ClH/c1-2-15-12-5-3-4-6-13(12)17-10-11-9-14-7-8-16-11;/h3-6,11,14H,2,7-10H2,1H3;1H
2.1.3 InChI Key
HJOCKFVCMLCPTP-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCOC1=CC=CC=C1OCC2CNCCO2.Cl
2.2 Other Identifiers
2.2.1 UNII
OQW30I1332
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Emovit

2. Ici-58,834

3. Ici58,834

4. Viloxazine

5. Viloxazine Hydrochloride, (r)-isomer

6. Viloxazine Hydrochloride, (s)-isomer

7. Viloxazine Oxalate (1:1)

8. Viloxazine, (+-)-isomer

9. Viloxazine, (r)-isomer

10. Viloxazine, (s)-isomer

11. Vivalan

2.3.2 Depositor-Supplied Synonyms

1. 35604-67-2

2. 2-((2-ethoxyphenoxy)methyl)morpholine Hydrochloride

3. Viloxazine Hcl

4. Vivalan

5. Emovit

6. Vicilan

7. 2-[(2-ethoxyphenoxy)methyl]morpholine Hydrochloride

8. Rac Viloxazine Hydrochloride

9. Viloxacina Clorhidrato

10. Ici 58,834

11. Viloxazine Hydrochloride [usan]

12. 2-((2-ethoxyphenoxy)methyl)morpholinehydrochloride

13. 2-[(2-ethoxyphenoxy)methyl]morpholine;hydrochloride

14. 2-((o-ethoxyphenoxy)methyl)morpholine Hydrochloride

15. Spn-812

16. Oqw30i1332

17. Qelbree

18. 2-[(2-ethoxy Phenoxy)methyl]morpholine Hydrochloride

19. Morpholine, 2-((2-ethoxyphenoxy)methyl)-, Hydrochloride

20. Morpholine, 2-[(2-ethoxyphenoxy)methyl]-, Hydrochloride

21. Ici-58834

22. Viloxazine Hydrochloride (usan)

23. Ccris 1915

24. Viloxacina Clorhidrato [spanish]

25. Einecs 252-638-6

26. Unii-oqw30i1332

27. Prestwick_734

28. Vivalan (tn)

29. Cloridrato De Viloxazina

30. 2-(2-ethoxyphenoxymethyl)tetrahydro-1,4-oxazine Hydrochloride

31. Chlorhydrate De Viloxazine

32. 2-(2-ethoxyphenoxymethyl)-2,3,5,6-tetrahydro-1,4-oxazine Hydrochloride

33. Dsstox_cid_31511

34. Dsstox_rid_97396

35. Dsstox_gsid_57722

36. Schembl300741

37. Chembl2106483

38. Dtxsid8057722

39. Glxc-25714

40. Tox21_113955

41. Viloxazine Hydrochloride [mi]

42. Akos015847050

43. At27980

44. Ccg-220828

45. Viloxazine Hydrochloride [mart.]

46. Ncgc00262964-01

47. Viloxazine Hydrochloride [who-dd]

48. Cas-35604-67-2

49. A6217

50. Ft-0675815

51. Ft-0675816

52. Ft-0675817

53. Ft-0675818

54. Ft-0675819

55. Viloxazine Hydrochloride [orange Book]

56. D02572

57. 2-(o-ethoxyphenoxymethyl)morpholine Hydrochloride

58. 604e672

59. Sr-01000872636

60. Sr-01000872636-1

61. W-110863

62. 2-(2-ethoxy-phenoxymethyl)-morpholine; Hydrochloride

63. 2-[(2-ethoxyphenoxy)-methyl]morpholine Hydrochloride

64. Q27285797

65. 2-(2-ethoxy-phenoxymethyl)-tetra-hydro-1,4-oxazine Hydrochloride

66. (+/-)-morpholine, 2-((2-ethoxyphenoxy)methyl)-, Hydrochloride

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 273.75 g/mol
Molecular Formula C13H20ClNO3
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count4
Rotatable Bond Count5
Exact Mass273.1131712 g/mol
Monoisotopic Mass273.1131712 g/mol
Topological Polar Surface Area39.7 Ų
Heavy Atom Count18
Formal Charge0
Complexity213
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Antidepressive Agents, Second-Generation

A structurally and mechanistically diverse group of drugs that are not tricyclics or monoamine oxidase inhibitors. The most clinically important appear to act selectively on serotonergic systems, especially by inhibiting serotonin reuptake. (See all compounds classified as Antidepressive Agents, Second-Generation.)


Adrenergic Uptake Inhibitors

Drugs that block the transport of adrenergic transmitters into axon terminals or into storage vesicles within terminals. The tricyclic antidepressants (ANTIDEPRESSIVE AGENTS, TRICYCLIC) and amphetamines are among the therapeutically important drugs that may act via inhibition of adrenergic transport. Many of these drugs also block transport of serotonin. (See all compounds classified as Adrenergic Uptake Inhibitors.)


4.2 FDA Pharmacological Classification
4.2.1 Pharmacological Classes
Cytochrome P450 2B6 Inhibitors [MoA]; Cytochrome P450 2D6 Inhibitors [MoA]; Cytochrome P450 3A4 Inhibitors [MoA]; Norepinephrine Reuptake Inhibitor [EPC]; Norepinephrine Uptake Inhibitors [MoA]; Cytochrome P450 1A2 Inhibitors [MoA]

API SUPPLIERS

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Macsen Labs

India

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Cosma (C.F.M. Group)

Italy

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ChemWerth Inc

U.S.A

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Virtual BoothChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Biophore India Pharmaceuticals Pvt...

India

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Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Bachem AG

Switzerland

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Virtual BoothBachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

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Metrochem API Private Limited

India

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Zhejiang Hengkang Pharmaceutical

China

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Neuland Laboratories

India

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Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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Granules India Limited

India

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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Amsa

Italy

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Drugs in Development

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Details:

Qelbree (viloxazine HCl) is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.


Lead Product(s): Viloxazine Hydrochloride,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Qelbree

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 27, 2025

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01

Arvo
Not Confirmed
Arvo
Not Confirmed

Details : Qelbree (viloxazine HCl) is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

Product Name : Qelbree

Product Type : Miscellaneous

Upfront Cash : Inapplicable

January 27, 2025

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Details:

An agreement aims to seek regulatory approval for Qelbree, an extended-release formulation of viloxazine for ADHD in children and adults.


Lead Product(s): Viloxazine Hydrochloride,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Qelbree

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Moksha8 Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement May 07, 2024

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02

Arvo
Not Confirmed
Arvo
Not Confirmed

Details : An agreement aims to seek regulatory approval for Qelbree, an extended-release formulation of viloxazine for ADHD in children and adults.

Product Name : Qelbree

Product Type : Miscellaneous

Upfront Cash : Undisclosed

May 07, 2024

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Details:

SPN-812 is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of undefined medical condition.


Lead Product(s): Viloxazine Hydrochloride,Inapplicable

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 14, 2024

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03

Arvo
Not Confirmed
Arvo
Not Confirmed

Details : SPN-812 is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of undefined medical condition.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 14, 2024

blank

Details:

SPN-812 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): Viloxazine Hydrochloride,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 29, 2023

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04

Arvo
Not Confirmed
Arvo
Not Confirmed

Details : SPN-812 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

December 29, 2023

blank

Details:

Viloxazine is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Sleep Apnea, Obstructive.


Lead Product(s): Viloxazine Hydrochloride,AD816

Therapeutic Area: Sleep Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 31, 2023

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05

Apnimed

U.S.A
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Arvo
Not Confirmed

Apnimed

U.S.A
arrow
Arvo
Not Confirmed

Details : Viloxazine is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Sleep Apnea, Obstructive.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

March 31, 2023

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Details:

At daily flexible-dose 200 to 600mg, Phase III trial met primary endpoint showing reduction change from baseline of Adult ADHD Investigator Symptom Rating Scale total score at end of study was statistically significantly greater in adults treated with Qelbree versus placebo.


Lead Product(s): Viloxazine Hydrochloride,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Qelbree

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 29, 2022

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06

Arvo
Not Confirmed
Arvo
Not Confirmed

Details : At daily flexible-dose 200 to 600mg, Phase III trial met primary endpoint showing reduction change from baseline of Adult ADHD Investigator Symptom Rating Scale total score at end of study was statistically significantly greater in adults treated with Qe...

Product Name : Qelbree

Product Type : Miscellaneous

Upfront Cash : Inapplicable

April 29, 2022

blank

Details:

The approval of Qelbree is supported by data from an extensive development program consisting of four Phase III clinical trials that studied more than 1000 pediatric patients from the age of 6 to 17 years.


Lead Product(s): Viloxazine Hydrochloride,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Qelbree

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 02, 2021

blank

07

Arvo
Not Confirmed
Arvo
Not Confirmed

Details : The approval of Qelbree is supported by data from an extensive development program consisting of four Phase III clinical trials that studied more than 1000 pediatric patients from the age of 6 to 17 years.

Product Name : Qelbree

Product Type : Miscellaneous

Upfront Cash : Inapplicable

April 02, 2021

blank

Details:

SPN-812 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): Viloxazine Hydrochloride,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 08, 2021

blank

08

Arvo
Not Confirmed
Arvo
Not Confirmed

Details : SPN-812 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

March 08, 2021

blank

Details:

SPN-812 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): Viloxazine Hydrochloride,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 04, 2021

blank

09

Arvo
Not Confirmed
Arvo
Not Confirmed

Details : SPN-812 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

March 04, 2021

blank

Details:

If approved by the FDA, the Company is preparing for the commercial launch of SPN-812 for the treatment of ADHD in pediatric patients in the second quarter of 2021.


Lead Product(s): Viloxazine Hydrochloride,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Qelbree

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 22, 2021

blank

10

Arvo
Not Confirmed
Arvo
Not Confirmed

Details : If approved by the FDA, the Company is preparing for the commercial launch of SPN-812 for the treatment of ADHD in pediatric patients in the second quarter of 2021.

Product Name : Qelbree

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 22, 2021

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APIs

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Patents & EXCLUSIVITIES

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US Patents

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01

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PCC
Not Confirmed
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PCC
Not Confirmed

VILOXAZINE HYDROCHLORIDE

US Patent Number : 11324753

Drug Substance Claim :

Drug Product Claim :

Application Number : 211964

Patent Use Code : U-727

Delist Requested :

Patent Use Description : FOR THE TREATMENT OF A...

Patent Expiration Date : 2029-09-04

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02

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PCC
Not Confirmed
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PCC
Not Confirmed

VILOXAZINE HYDROCHLORIDE

US Patent Number : 11324753

Drug Substance Claim :

Drug Product Claim :

Application Number : 211964

Patent Use Code : U-727

Delist Requested :

Patent Use Description : FOR THE TREATMENT OF A...

Patent Expiration Date : 2029-09-04

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03

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PCC
Not Confirmed
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PCC
Not Confirmed

VILOXAZINE HYDROCHLORIDE

US Patent Number : 9662338

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 211964

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-04-02

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04

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PCC
Not Confirmed
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PCC
Not Confirmed

VILOXAZINE HYDROCHLORIDE

US Patent Number : 9603853

Drug Substance Claim :

Drug Product Claim :

Application Number : 211964

Patent Use Code : U-727

Delist Requested :

Patent Use Description : FOR THE TREATMENT OF A...

Patent Expiration Date : 2033-02-07

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05

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PCC
Not Confirmed
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PCC
Not Confirmed

VILOXAZINE HYDROCHLORIDE

US Patent Number : 11324753

Drug Substance Claim :

Drug Product Claim :

Application Number : 211964

Patent Use Code : U-727

Delist Requested :

Patent Use Description : FOR THE TREATMENT OF A...

Patent Expiration Date : 2029-09-04

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06

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PCC
Not Confirmed
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PCC
Not Confirmed

VILOXAZINE HYDROCHLORIDE

US Patent Number : 12121523

Drug Substance Claim :

Drug Product Claim :

Application Number : 211964

Patent Use Code : U-727

Delist Requested :

Patent Use Description : FOR THE TREATMENT OF A...

Patent Expiration Date : 2029-09-04

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07

arrow
PCC
Not Confirmed
arrow
PCC
Not Confirmed

VILOXAZINE HYDROCHLORIDE

US Patent Number : 9662338

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 211964

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-04-02

blank

08

arrow
PCC
Not Confirmed
arrow
PCC
Not Confirmed

VILOXAZINE HYDROCHLORIDE

US Patent Number : 9603853

Drug Substance Claim :

Drug Product Claim :

Application Number : 211964

Patent Use Code : U-727

Delist Requested :

Patent Use Description : FOR THE TREATMENT OF A...

Patent Expiration Date : 2033-02-07

blank

09

arrow
PCC
Not Confirmed
arrow
PCC
Not Confirmed

VILOXAZINE HYDROCHLORIDE

US Patent Number : 11458143

Drug Substance Claim :

Drug Product Claim :

Application Number : 211964

Patent Use Code : U-727

Delist Requested :

Patent Use Description : FOR THE TREATMENT OF A...

Patent Expiration Date : 2029-09-04

blank

10

arrow
PCC
Not Confirmed
arrow
PCC
Not Confirmed

VILOXAZINE HYDROCHLORIDE

US Patent Number : 9603853

Drug Substance Claim :

Drug Product Claim :

Application Number : 211964

Patent Use Code : U-727

Delist Requested :

Patent Use Description : FOR THE TREATMENT OF A...

Patent Expiration Date : 2033-02-07

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US Exclusivities

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Bioprocess International Europe
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Bioprocess International Europe
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VILOXAZINE HYDROCHLORIDE

Exclusivity Code : NCE

Exclusivity Expiration Date : 2026-04-02

Application Number : 211964

Product Number : 1

Exclusivity Details :

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02

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Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

VILOXAZINE HYDROCHLORIDE

Exclusivity Code : NCE

Exclusivity Expiration Date : 2026-04-02

Application Number : 211964

Product Number : 2

Exclusivity Details :

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03

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Bioprocess International Europe
Not Confirmed
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Bioprocess International Europe
Not Confirmed

VILOXAZINE HYDROCHLORIDE

Exclusivity Code : NCE

Exclusivity Expiration Date : 2026-04-02

Application Number : 211964

Product Number : 3

Exclusivity Details :

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API | Excipient name

Viloxazine Hydrochloride

Synonyms

35604-67-2, 2-((2-ethoxyphenoxy)methyl)morpholine hydrochloride, Viloxazine hcl, Vivalan, Emovit, Vicilan

Cas Number

35604-67-2

Unique Ingredient Identifier (UNII)

OQW30I1332

About Viloxazine Hydrochloride

A morpholine derivative used as an antidepressant. It is similar in action to IMIPRAMINE.

DSSTox_CID_31511 Manufacturers

A DSSTox_CID_31511 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DSSTox_CID_31511, including repackagers and relabelers. The FDA regulates DSSTox_CID_31511 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DSSTox_CID_31511 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 DSSTox_CID_31511 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.

DSSTox_CID_31511 Suppliers

A DSSTox_CID_31511 supplier is an individual or a company that provides DSSTox_CID_31511 active pharmaceutical ingredient (API) or DSSTox_CID_31511 finished formulations upon request. The DSSTox_CID_31511 suppliers may include DSSTox_CID_31511 API manufacturers, exporters, distributors and traders.

click here to find a list of DSSTox_CID_31511 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.

DSSTox_CID_31511 USDMF

A DSSTox_CID_31511 DMF (Drug Master File) is a document detailing the whole manufacturing process of DSSTox_CID_31511 active pharmaceutical ingredient (API) in detail. Different forms of DSSTox_CID_31511 DMFs exist exist since differing nations have different regulations, such as DSSTox_CID_31511 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A DSSTox_CID_31511 DMF submitted to regulatory agencies in the US is known as a USDMF. DSSTox_CID_31511 USDMF includes data on DSSTox_CID_31511's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DSSTox_CID_31511 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of DSSTox_CID_31511 suppliers with USDMF on PharmaCompass.

DSSTox_CID_31511 WC

A DSSTox_CID_31511 written confirmation (DSSTox_CID_31511 WC) is an official document issued by a regulatory agency to a DSSTox_CID_31511 manufacturer, verifying that the manufacturing facility of a DSSTox_CID_31511 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting DSSTox_CID_31511 APIs or DSSTox_CID_31511 finished pharmaceutical products to another nation, regulatory agencies frequently require a DSSTox_CID_31511 WC (written confirmation) as part of the regulatory process.

click here to find a list of DSSTox_CID_31511 suppliers with Written Confirmation (WC) on PharmaCompass.

DSSTox_CID_31511 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 DSSTox_CID_31511 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for DSSTox_CID_31511 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 DSSTox_CID_31511 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 DSSTox_CID_31511 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DSSTox_CID_31511 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of DSSTox_CID_31511 suppliers with NDC on PharmaCompass.

DSSTox_CID_31511 GMP

DSSTox_CID_31511 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 DSSTox_CID_31511 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right DSSTox_CID_31511 GMP manufacturer or DSSTox_CID_31511 GMP API supplier for your needs.

DSSTox_CID_31511 CoA

A DSSTox_CID_31511 CoA (Certificate of Analysis) is a formal document that attests to DSSTox_CID_31511's compliance with DSSTox_CID_31511 specifications and serves as a tool for batch-level quality control.

DSSTox_CID_31511 CoA mostly includes findings from lab analyses of a specific batch. For each DSSTox_CID_31511 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.

DSSTox_CID_31511 may be tested according to a variety of international standards, such as European Pharmacopoeia (DSSTox_CID_31511 EP), DSSTox_CID_31511 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DSSTox_CID_31511 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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