ALPHATREX

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

48 API Suppliers, 16 USDMF, 7 CEP/COS, 6 JDMF, 8 EU WC, 2 KDMF, 11 NDC API, 31 Listed Suppliers

DEVELOPMENTS

6 Drug(s) in Development

6 Drug(s) in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

DOSSIERs // Finished Dosage Formulations

146 Dossiers, 78 FDA Orange Book, 6 Europe, 3 Canada, 24 Australia, 9 South Africa, 26 Listed Dossiers

DRUG PRODUCT COMPOSITION

OINTMENT, AUGMENTED;TOPICAL - EQ 0.05% BASE, CREAM;TOPICAL - EQ 0.05% BASE;1%, CREAM;TOPICAL - EQ 0.05% BASE, OINTMENT;TOPICAL - EQ 0.05% BASE, CREAM, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, LOTION, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, OINTMENT;TOPICAL - 0.064%;0.005%, SUSPENSION;TOPICAL - 0.064%;0.005%

OINTMENT, AUGMENTED;TOPICAL - EQ 0.05% BASE
CREAM;TOPICAL - EQ 0.05% BASE;1%
CREAM;TOPICAL - EQ 0.05% BASE
OINTMENT;TOPICAL - EQ 0.05% BASE
CREAM, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
LOTION, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
OINTMENT;TOPICAL - 0.064%;0.005%
SUSPENSION;TOPICAL - 0.064%;0.005%

RELATED EXCIPIENT COMPANIES

Suppliers, 11 Roquette, 11 BASF, 8 Nanjing Well Pharmaceutical, 4 Corel Pharma Chem, 4 Lubrizol Life Science Health, 2 SPI Pharma, 2 Shandong Focus Biotechnology Co., Ltd, 2 Finar, 1 Actylis, 1 Seppic, 1 DKSH, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Zhejiang Huakang Pharmaceutical, 1 Alcedo Pharmachem, 1 Kerry, 1 Clariant, 1 Gangwal Healthcare, 1 Rochem International Inc

EXCIPIENTS BY APPLICATIONS

23 Topical, 14 Film Formers & Plasticizers, 8 Parenteral, 7 Emulsifying Agents, 6 Fillers, Diluents & Binders, 6 Solubilizers, 5 Lubricants & Glidants, 5 Thickeners and Stabilizers, 5 Coating Systems & Additives, 4 Controlled & Modified Release, 4 Taste Masking, 3 Direct Compression, 2 Granulation, 2 Surfactant & Foaming Agents, 2 Chewable & Orodispersible Aids, 1 Soft Gelatin, 1 Rheology Modifiers, 1 Co-Processed Excipients

GLOBAL SALES INFORMATION

54 US Medicaid Prescriptions, 16 Finished Drug Prices

MARKET PLACE

18 APIs, 1 DOSSIERS // FDF

PATENTS

20 US Patents

20 US Patents

ANALYTICAL SOLUTION(s)

3 EDQM Standards, 1 USP Standards, 5 Other Ref. Standards

DIGITAL CONTENT

1 Data Compilations & Company Tracker #PharmaFlow, 47 News

Product Search

API SUPPLIERS

API Suppliers

US DMFs Filed

CEP/COS Certifications

JDMFs Filed

Other Certificates

Other Suppliers

API REF. PRICE (USD / KG)

1,363

API Market Place

INTERMEDIATES

DOSSIERS // FDF

USA (Orange Book)

Europe

Canada

Australia

South Africa

Uploaded Dossiers

GLOBAL SALES (USD Million)

U.S. Medicaid

599.00

Annual Reports

FDF Market Place

EXCIPIENTS

PATENTS & EXCLUSIVITIES

USFDA Orange Book Patents

USFDA Exclusivities

DIGITAL CONTENT

Blog #PharmaFlow

News

REF STANDARD

EDQM

USP

Other Listed Suppliers

SERVICES

Also known as: Diprolene, Diprosone, 5593-20-4, Maxivate, Diprolene af, Alphatrex

Molecular Formula

C₂₈H₃₇FO₇

Molecular Weight

504.6 g/mol

InChI Key

CIWBQSYVNNPZIQ-XYWKZLDCSA-N

FDA UNII

826Y60901U

Betamethasone Dipropionate is the 17,21-dipropionate ester of betamethasone, a synthetic glucocorticoid with metabolic, immunosuppressive and anti-inflammatory actions. Betamethasone dipropionate binds to specific intracellular glucocorticoid receptors and subsequently binds to DNA to modify gene expression. The synthesis of certain anti-inflammatory proteins is induced while the synthesis of certain inflammatory mediators is inhibited. As a result, there is an overall reduction in chronic inflammation and autoimmune reactions.

1 2D Structure

ALPHATREX

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

[2-[(8S,9R,10S,11S,13S,14S,16S,17R)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] propanoate

2.1.2 InChI

InChI=1S/C28H37FO7/c1-6-23(33)35-15-22(32)28(36-24(34)7-2)16(3)12-20-19-9-8-17-13-18(30)10-11-25(17,4)27(19,29)21(31)14-26(20,28)5/h10-11,13,16,19-21,31H,6-9,12,14-15H2,1-5H3/t16-,19-,20-,21-,25-,26-,27-,28-/m0/s1

2.1.3 InChI Key

CIWBQSYVNNPZIQ-XYWKZLDCSA-N

2.1.4 Canonical SMILES

CCC(=O)OCC(=O)C1(C(CC2C1(CC(C3(C2CCC4=CC(=O)C=CC43C)F)O)C)C)OC(=O)CC

2.1.5 Isomeric SMILES

CCC(=O)OCC(=O)[C@]1([C@H](C[C@@H]2[C@@]1(C[C@@H]([C@]3([C@H]2CCC4=CC(=O)C=C[C@@]43C)F)O)C)C)OC(=O)CC

2.2 Other Identifiers

2.2.1 UNII

826Y60901U

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Augmented Betamethasone Dipropionate

2. Beloderm

3. Betamethasone Propionate

4. Betamethasone-17,21-dipropionate

5. Diprolene

6. Diprosone

7. Maxivate

2.3.2 Depositor-Supplied Synonyms

1. Diprolene

2. Diprosone

3. 5593-20-4

4. Maxivate

5. Diprolene Af

6. Alphatrex

7. Diproderm

8. Psorion

9. Betamethasone 17,21-dipropionate

10. Rinderon Dp

11. Diprosis

12. Diprospan

13. Sch 11460

14. Sch-11460

15. S-3440

16. Betamethasone (as Dipropionate)

17. Betamethasone-17,21-dipropionate

18. Chebi:31276

19. Nsc-758415

20. Pregna-1,4-diene-3,20-dione,9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11b,16b)-

21. Beta-methasone 17,21-dipropionate

22. 826y60901u

23. [2-[(8s,9r,10s,11s,13s,14s,16s,17r)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] Propanoate

24. (11-beta,16-beta)-9-chloro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione

25. 9-fluoro-11beta-hydroxy-16beta-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl Dipropanoate

26. 9-fluoro-11.beta.,17,21-trihydroxy-16.beta.-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate

27. 9-fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate

28. Einecs 227-005-2

29. Brn 3638108

30. .beta.-methasone 17,21-dipropionate

31. Betamethasone Dipropionate (diprolene)

32. S 3440

33. Diprolene (tn)

34. Unii-826y60901u

35. Ncgc00159360-02

36. Ncgc00159443-02

37. Pregna-1,4-diene-3,20-dione, 9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11.beta.,16.beta.)-

38. Sernivo (tn)

39. Rinderon-dp (tn)

40. Betamethasone Dipropionate [usan:usp:jan]

41. Betamethasone-dipropionate

42. Dsstox_cid_2672

43. Betamethasone Diprop

44. Schembl7519

45. 9-fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate

46. Dsstox_rid_76683

47. Dsstox_gsid_22672

48. 9-fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17,21-di(propionate)

49. Betamethasone-17,21-dipropionate 100 Microg/ml In Acetonitrile

50. Chembl1200384

51. Dtxsid2022672

52. Component Of Betasone (salt/mix)

53. Component Of Alphatrex (salt/mix)

54. Amy22130

55. Zinc4212137

56. Tox21_113343

57. Bdbm50421892

58. S1688

59. Akos015969733

60. Betamethasone Dipropionate (jp17/usp)

61. Ccg-269732

62. Cs-7549

63. Ks-5303

64. Nsc 758415

65. Betamethasone Dipropionate [jan]

66. Betamethasone Dipropionate [usan]

67. Ncgc00159443-01

68. Ncgc00159443-05

69. (11beta,16beta)-9-fluoro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl Dipropanoate

70. 2-((2s,10s,11s,13s,15s,17s,1r,14r)-1-fluoro-17-hydroxy-2,13,15-trimethyl-5-oxo -14-propanoyloxytetracyclo[8.7.0.0<2,7>.0<11,15>]heptadeca-3,6-dien-14-yl)-2-o Xoethyl Propanoate

71. Betamethasone Dipropionate [mart.]

72. Betamethasone Dipropionate [vandf]

73. Hy-13571

74. Pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,17,21-trihydroxy-16-beta-methyl-, 17,21-dipropionate

75. Pregna-1,4-diene-3,20-dione, 9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11beta,16beta)

76. Betamethasone Dipropionate [usp-rs]

77. Betamethasone Dipropionate [who-dd]

78. Cas-5593-20-4

79. Betamethasone Dipropionate, Augmented

80. B3166

81. Betamethasone 17,21-dipropionate [mi]

82. Betamethasone Dipropionate [green Book]

83. Betamethasone Dipropionate [orange Book]

84. D01637

85. Ab01274713-01

86. Ab01274713_02

87. Betamethasone 17.alpha.,21-dipropionate

88. Betamethasone Dipropionate [ep Monograph]

89. Betamethasone Dipropionate [usp Monograph]

90. Wynzora Component Betamethasone Dipropionate

91. Enstilar Component Betamethasone Dipropionate

92. Lotrisone Component Betamethasone Dipropionate

93. Q4897349

94. Taclonex Component Betamethasone Dipropionate

95. Betamethasone Dipropionate Component Of Enstilar

96. Betamethasone Dipropionate Component Of Taclonex

97. Betamethasone Dipropionate Component Of Wynzora

98. Brd-k58148589-001-03-6

99. Leo-90100 Component Betamethasone Dipropionate

100. Betamethasone Dipropionate Component Of Lotrisone

101. Betamethasone Dipropionate Component Of Leo-90100

102. Betamethasone-17,21-dipropionate 100 Microg/ml In Methanol

103. (11.beta.,16.beta.)-9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate

104. 9-fluoro-11.beta.-hydroxy-16.beta.-methyl-3,20-dioxo-17-(propionyloxy)pregna-1,4-dien-21-yl Propionate #

105. 9alpha-fluoro-11beta,17alpha,21-trihydroxy-16beta-methyl-1,4-pregnadiene-3,20-dione 17,21-dipropionate

106. 9alpha-fluoro-11beta,17alpha,21-trihydroxy-16beta-methyl-3,20-dioxopregna-1,4-diene- 17,21-diyl Dipropionate

107. Pregna-1,4-diene-3,20-dione, 9-fluoro-11-.beta.,17,21-trihydroxy-16-.beta.-methyl-,17,21-dipropionate

108. Pregna-1,4-diene-3,20-dione, 9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11.beta.,16.beta.)

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₂₈H₃₇FO₇
Molecular Weight	504.6 g/mol
XLogP3	3.6
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	8
Rotatable Bond Count	8
Exact Mass	504.25233168 g/mol
Monoisotopic Mass	504.25233168 g/mol
Topological Polar Surface Area	107 Å²
Heavy Atom Count	36
Formal Charge	0
Complexity	1050
Isotope Atom Count	0
Defined Atom Stereocenter Count	8
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Betamethasone dipropionate
PubMed Health	Betamethasone Dipropionate (On the skin)
Drug Classes	Corticosteroid, Strong
Drug Label	Betamethasone Dipropionate Lotion USP 0.05% (Augmented) contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a sli...
Active Ingredient	Betamethasone dipropionate
Dosage Form	Lotion; Ointment, augmented; Ointment; Lotion, augmented; Cream; Cream, augmented; Gel, augmented
Route	Topical
Strength	eq 0.05% base
Market Status	Prescription
Company	Glenmark Generics; Fougera Pharms; Actavis Mid Atlantic; Teva; Perrigo New York; Taro; Fougera; Tolmar

2 of 6
Drug Name	Diprolene
PubMed Health	Betamethasone Dipropionate, Augmented (On the skin)
Drug Classes	Corticosteroid, Very Strong
Drug Label	DIPROLENE (augmented betamethasone dipropionate) Ointment contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a...
Active Ingredient	Betamethasone dipropionate
Dosage Form	Ointment, augmented; Lotion, augmented
Route	Topical
Strength	eq 0.05% base
Market Status	Prescription
Company	Merck Sharp Dohme

3 of 6
Drug Name	Diprolene af
PubMed Health	Betamethasone Dipropionate, Augmented (On the skin)
Drug Classes	Corticosteroid, Very Strong
Drug Label	DIPROLENE AF Cream 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use in an emollient base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degre...
Active Ingredient	Betamethasone dipropionate
Dosage Form	Cream, augmented
Route	Topical
Strength	eq 0.05% base
Market Status	Prescription
Company	Merck Sharp Dohme

4 of 6
Drug Name	Betamethasone dipropionate
PubMed Health	Betamethasone Dipropionate (On the skin)
Drug Classes	Corticosteroid, Strong
Drug Label	Betamethasone Dipropionate Lotion USP 0.05% (Augmented) contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a sli...
Active Ingredient	Betamethasone dipropionate
Dosage Form	Lotion; Ointment, augmented; Ointment; Lotion, augmented; Cream; Cream, augmented; Gel, augmented
Route	Topical
Strength	eq 0.05% base
Market Status	Prescription
Company	Glenmark Generics; Fougera Pharms; Actavis Mid Atlantic; Teva; Perrigo New York; Taro; Fougera; Tolmar

5 of 6
Drug Name	Diprolene
PubMed Health	Betamethasone Dipropionate, Augmented (On the skin)
Drug Classes	Corticosteroid, Very Strong
Drug Label	DIPROLENE (augmented betamethasone dipropionate) Ointment contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a...
Active Ingredient	Betamethasone dipropionate
Dosage Form	Ointment, augmented; Lotion, augmented
Route	Topical
Strength	eq 0.05% base
Market Status	Prescription
Company	Merck Sharp Dohme

6 of 6
Drug Name	Diprolene af
PubMed Health	Betamethasone Dipropionate, Augmented (On the skin)
Drug Classes	Corticosteroid, Very Strong
Drug Label	DIPROLENE AF Cream 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use in an emollient base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degre...
Active Ingredient	Betamethasone dipropionate
Dosage Form	Cream, augmented
Route	Topical
Strength	eq 0.05% base
Market Status	Prescription
Company	Merck Sharp Dohme

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Anti-Inflammatory Agents

Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory Agents.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Corticosteroid [EPC]; Corticosteroid Hormone Receptor Agonists [MoA]

Find Betamethasone Dipropionate manufacturers, exporters & distributors on PharmaCompass

ALPHATREX

ALPHATREX

Synopsis

Chemistry

APIs // Active Pharmaceutical Ingredients

48 API Suppliers

16 USDMF

7 CEP/COS

6 JDMF

8 EU WC

2 KDMF

11 NDC API

31 Listed Suppliers

DEVELOPMENTS

6 Drug(s) in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

DOSSIERs // Finished Dosage Formulations

146 Dossiers

78 FDA Orange Book

6 Europe

3 Canada

24 Australia

9 South Africa

26 Listed Dossiers

DRUG PRODUCT COMPOSITION

OINTMENT, AUGMENTED;TOPICAL - EQ 0.05% BASE

CREAM;TOPICAL - EQ 0.05% BASE;1%

CREAM;TOPICAL - EQ 0.05% BASE

OINTMENT;TOPICAL - EQ 0.05% BASE

CREAM, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

LOTION, AUGMENTED;TOPICAL - EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

OINTMENT;TOPICAL - 0.064%;0.005%

SUSPENSION;TOPICAL - 0.064%;0.005%

RELATED EXCIPIENT COMPANIES

Suppliers

11 Roquette

11 BASF

8 Nanjing Well Pharmaceutical

4 Corel Pharma Chem

4 Lubrizol Life Science Health

2 SPI Pharma

2 Shandong Focus Biotechnology Co., Ltd

2 Finar

1 Actylis

1 Seppic

1 DKSH

1 Shijiazhuang Huaxu Pharmaceutical

1 Zhejiang Huakang Pharmaceutical

1 Alcedo Pharmachem

1 Kerry

1 Clariant

1 Gangwal Healthcare

1 Rochem International Inc

EXCIPIENTS BY APPLICATIONS

23 Topical

14 Film Formers & Plasticizers

8 Parenteral

7 Emulsifying Agents

6 Fillers, Diluents & Binders

6 Solubilizers

5 Lubricants & Glidants

5 Thickeners and Stabilizers

5 Coating Systems & Additives

4 Controlled & Modified Release

4 Taste Masking

3 Direct Compression

2 Granulation

2 Surfactant & Foaming Agents

2 Chewable & Orodispersible Aids

1 Soft Gelatin

1 Rheology Modifiers

1 Co-Processed Excipients

GLOBAL SALES INFORMATION

54 US Medicaid Prescriptions

CREAM, AUGMENTED;TOPICAL - EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

LOTION, AUGMENTED;TOPICAL - EQ 0.05% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons