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ACTIVE PHARMA INGREDIENTS

24 API Suppliers, 6 USDMF, 1 CEP/COS, 17 JDMF, 3 EU WC, 12 KDMF, 2 NDC API, 5 Listed Suppliers, $ API Reference Price

24 API Suppliers
6 USDMF
1 CEP/COS
17 JDMF
3 EU WC
12 KDMF
2 NDC API
5 Listed Suppliers
$ API Reference Price

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

15 FDF Dossiers, 8 FDA Orange Book, 3 Europe, 1 South Africa, 3 Listed Dossiers

15 FDF Dossiers
8 FDA Orange Book
3 Europe
1 South Africa
3 Listed Dossiers

RELATED EXCIPIENT COMPANIES

5 Actylis, 1 Finar

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5 Actylis
1 Finar

EXCIPIENTS BY APPLICATIONS

4 Parenteral, 2 Solubilizers

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4 Parenteral
2 Solubilizers

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 2 NEWS #PharmaBuzz

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1 DATA COMPILATION #PharmaFlow
2 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 6 Finished Drug Prices

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1 US Medicaid Prescriptions
6 Finished Drug Prices

MARKET PLACE

3 APIs, 2 FDF Dossiers

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3 APIs
2 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM , 1 USP , 2 Others

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2 EDQM
1 USP
2 Others

Chemwerth Epinastine Hydrochloride

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

MARKET PLACE

API

FDF

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

1,640,811

Annual Reports (USD Million)

Finished Drug Prices

6EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Epinastine hcl, 108929-04-0, Alesion, Elestat, Wal-801cl, 80012-44-8

Molecular Formula

C₁₆H₁₆ClN₃

Molecular Weight

285.77 g/mol

InChI Key

VKXSGUIOOQPGAF-UHFFFAOYSA-N

FDA UNII

GFM415S5XL

Epinastine Hydrochloride is an histamine H1 receptor antagonist without sedative activity. Epinastine hydrochloride blocks the histamine H1 receptor and inhibits the release of histamine from mast cells. This prevents the typical allergic symptoms that are caused by histamine activity on capillaries, skin, mucous membranes, and on gastrointestinal and bronchial smooth muscles. Typical histamine activities include vasodilation, bronchoconstriction, increased vascular permeability, pain, itching, and spasmodic contractions of gastrointestinal smooth muscles. Epinastine also has affinity for the histamine H2, 5-HT2, and the alpha-1, alpha-2 adrenergic receptors.

1 2D Structure

Epinastine Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2,4-diazatetracyclo[12.4.0.02,6.07,12]octadeca-1(18),3,7,9,11,14,16-heptaen-3-amine;hydrochloride

2.1.2 InChI

InChI=1S/C16H15N3.ClH/c17-16-18-10-15-13-7-3-1-5-11(13)9-12-6-2-4-8-14(12)19(15)16;/h1-8,15H,9-10H2,(H2,17,18);1H

2.1.3 InChI Key

VKXSGUIOOQPGAF-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C1C2C3=CC=CC=C3CC4=CC=CC=C4N2C(=N1)N.Cl

2.2 Other Identifiers

2.2.1 UNII

GFM415S5XL

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 3-amino-9,13b-dihydro-1h-benz(c,f)imidazo(1,5a)azepine

2. Epinastine

3. Flurinol

4. Wal 80

5. Wal 801

6. Wal 801 Cl

7. Wal 801cl

8. Wal-80 Cl

2.3.2 Depositor-Supplied Synonyms

1. Epinastine Hcl

2. 108929-04-0

3. Alesion

4. Elestat

5. Wal-801cl

6. 80012-44-8

7. Wal 801 Cl

8. Epinastine Hydrochloride [jan]

9. De-114

10. Epinastine (hydrochloride)

11. Epinastinehydrochloride

12. Gfm415s5xl

13. Wal-802-cl

14. Wal801

15. Relestat

16. 3-amino-9,13b-dihydro-1h-dibenzo[c,f]imidazo[1,5-a]azepine Hydrochloride

17. 9,13b-dihydro-1h-dibenzo[c,f]imidazo[1,5-a]azepin-3-amine Hydrochloride

18. Dsstox_cid_26502

19. Dsstox_rid_81671

20. Dsstox_gsid_46502

21. Epinastine Hydrochloride (jan)

22. Epinastine Monohydrochloride

23. Chebi:51037

24. Cas-108929-04-0

25. Ncgc00165791-02

26. Unii-gfm415s5xl

27. Flurinol

28. (13brs)-9,13b-dihydro-1h-dibenzo[c,f]imidazo[1,5-a]azepin-3-amine Hydrochloride

29. Alesion (tn)

30. Elestat (tn)

31. Mfcd00933434

32. Epinastin Hydrochloride

33. 9,13b-dihydro-1h-dibenz[cf]imidazo[1,5-a]azepine Hydrochloride

34. Wal-801cl Hcl

35. 3-amino-9,13b-dihydro-1h-dibenz(c,f)imidazo(1,5-a)azepine Monohydrochloride

36. Schembl122749

37. Chembl1200491

38. Dtxsid1046502

39. Epinastine For System Suitability

40. Hy-b0640a

41. Hms3652n21

42. Hms3885b15

43. Bcp12119

44. Ex-a1004

45. Tox21_112263

46. Tox21_500501

47. Epinastine Hydrochloride [mi]

48. S4253

49. Akos015967222

50. Tox21_112263_1

51. Ac-1491

52. Ccg-221805

53. Ks-1159

54. Lp00501

55. Epinastine Hydrochloride [mart.]

56. Ih-dibenz(c,f)imidazo(1,5-a)azepin-3-amine, 9,13b-dihydro-, Monohydrochloride

57. Epinastine Hydrochloride [usp-rs]

58. Epinastine Hydrochloride [who-dd]

59. Ncgc00165791-04

60. Ncgc00261186-01

61. 2,4-diazatetracyclo[12.4.0.02,6.07,12]octadeca-1(18),3,7,9,11,14,16-heptaen-3-amine;hydrochloride

62. Db-040850

63. Cs-0013220

64. E0799

65. Ft-0631049

66. Ft-0700527

67. Sw220223-1

68. Epinastine Hydrochloride [orange Book]

69. D01713

70. Epinastine Hydrochloride [ep Monograph]

71. F17420

72. Epinastine Hydrochloride, >=98% (hplc), Solid

73. A857231

74. J-002209

75. Q27122286

76. Epinastine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

77. 1h-dibenz(c,f)imidazo(1,5-a)azepin-3-amine, 9,13b-dihydro-, Hydrochloride (1:1)

78. 3-amino-9,13b-dihydro-1h-dibenz(c,f)imidazo(1,5-a)azepine Hydrochloride, Dl-

79. Epinastine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

80. 2,4-diazatetracyclo[12.4.0.02,6.07,12]octadeca-1(18),3,7,9,11,14,16-heptaen-3-amine;hydron;chloride

81. Epinastine Hydrochloride For System Suitability, European Pharmacopoeia (ep) Reference Standard

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₆H₁₆ClN₃
Molecular Weight	285.77 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	1
Rotatable Bond Count	0
Exact Mass	285.1032752 g/mol
Monoisotopic Mass	285.1032752 g/mol
Topological Polar Surface Area	41.6 Å²
Heavy Atom Count	20
Formal Charge	0
Complexity	378
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Elestat
PubMed Health	Epinastine (Into the eye)
Drug Classes	Ophthalmologic Agent
Drug Label	ELESTAT (epinastine HCl ophthalmic solution) 0.05% is a clear, colorless, sterile isotonic solution containing epinastine HCl, an antihistamine and an inhibitor of histamine release from the mast cell for topical administration to the eyes. Epinast...
Active Ingredient	Epinastine hydrochloride
Dosage Form	Solution/drops
Route	Ophthalmic
Strength	0.05%
Market Status	Prescription
Company	Allergan

2 of 4
Drug Name	Epinastine hydrochloride
Drug Label	Epinastine HCl ophthalmic solution, 0.05% is a clear, colorless, sterile isotonic solution containing epinastine HCl, an antihistamine and an inhibitor of histamine release from the mast cell for topical administration to the eyes.Epinastine HCl is r...
Active Ingredient	Epinastine hydrochloride
Dosage Form	Solution/drops; Solution
Route	ophthalmic; Ophthalmic
Strength	0.05%
Market Status	Tentative Approval; Prescription
Company	Tesa Pharms; Breckenridge Pharm; Apotex; Sun Pharm Inds; Sandoz

3 of 4
Drug Name	Elestat
PubMed Health	Epinastine (Into the eye)
Drug Classes	Ophthalmologic Agent
Drug Label	ELESTAT (epinastine HCl ophthalmic solution) 0.05% is a clear, colorless, sterile isotonic solution containing epinastine HCl, an antihistamine and an inhibitor of histamine release from the mast cell for topical administration to the eyes. Epinast...
Active Ingredient	Epinastine hydrochloride
Dosage Form	Solution/drops
Route	Ophthalmic
Strength	0.05%
Market Status	Prescription
Company	Allergan

4 of 4
Drug Name	Epinastine hydrochloride
Drug Label	Epinastine HCl ophthalmic solution, 0.05% is a clear, colorless, sterile isotonic solution containing epinastine HCl, an antihistamine and an inhibitor of histamine release from the mast cell for topical administration to the eyes.Epinastine HCl is r...
Active Ingredient	Epinastine hydrochloride
Dosage Form	Solution/drops; Solution
Route	ophthalmic; Ophthalmic
Strength	0.05%
Market Status	Tentative Approval; Prescription
Company	Tesa Pharms; Breckenridge Pharm; Apotex; Sun Pharm Inds; Sandoz

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Histamine H1 Antagonists

Drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. Included here are the classical antihistaminics that antagonize or prevent the action of histamine mainly in immediate hypersensitivity. They act in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. (See all compounds classified as Histamine H1 Antagonists.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Adrenergic Receptor Agonist [EPC]; Decreased Histamine Release [PE]; Histamine H1 Receptor Antagonists [MoA]; Histamine-1 Receptor Inhibitor [EPC]; Adrenergic Agonists [MoA]

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API Reference Price

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