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Naltrexone Hydrochloride

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ACTIVE PHARMA INGREDIENTS

23 API Suppliers, 9 USDMF, 7 CEP/COS, 2 EU WC, 6 KDMF, 44 NDC API, 16 Listed Suppliers, $ API Reference Price

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9 USDMF
7 CEP/COS
2 EU WC
6 KDMF
44 NDC API
16 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

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14 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

47 FDF Dossiers, 23 FDA Orange Book, 14 Europe, 4 Canada, 2 South Africa, 4 Listed Dossiers

47 FDF Dossiers
23 FDA Orange Book
14 Europe
4 Canada
2 South Africa
4 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG, CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG
CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Evonik, 1 SPI Pharma, 2 Seqens, 8 DKSH, 2 Jai Radhe Sales, 9 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 17 BASF, 1 Clariant, 18 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 10 Gangwal Chemicals, 9 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 35 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 10 Roquette, 12 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 3 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

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47 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 17 Finished Drug Prices

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2 US Medicaid Prescriptions
17 Finished Drug Prices

MARKET PLACE

15 APIs, 3 FDF Dossiers

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15 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

88 US Patents

patents
88 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM , 7 Others

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2 EDQM
7 Others

Temad Naltrexone Hydrochloride

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

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CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 6,899

MARKET PLACE

API

FDF

2INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

14DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

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GLOBAL SALES INFORMATION

US Medicaid (USD)

71,210,546

Annual Reports (USD Million)

Finished Drug Prices

228 RELATED EXCIPIENT COMPANIES

379EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Naltrexone hcl, 16676-29-2, Trexan, Depade, Antaxone, Revia

Molecular Formula

C₂₀H₂₄ClNO₄

Molecular Weight

377.9 g/mol

InChI Key

RHBRMCOKKKZVRY-ITLPAZOVSA-N

FDA UNII

Z6375YW9SF

Derivative of noroxymorphone that is the N-cyclopropylmethyl congener of NALOXONE. It is a narcotic antagonist that is effective orally, longer lasting and more potent than naloxone, and has been proposed for the treatment of heroin addiction. The FDA has approved naltrexone for the treatment of alcohol dependence.

1 2D Structure

Naltrexone Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(4R,4aS,7aR,12bS)-3-(cyclopropylmethyl)-4a,9-dihydroxy-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride

2.1.2 InChI

InChI=1S/C20H23NO4.ClH/c22-13-4-3-12-9-15-20(24)6-5-14(23)18-19(20,16(12)17(13)25-18)7-8-21(15)10-11-1-2-11;/h3-4,11,15,18,22,24H,1-2,5-10H2;1H/t15-,18+,19+,20-;/m1./s1

2.1.3 InChI Key

RHBRMCOKKKZVRY-ITLPAZOVSA-N

2.1.4 Canonical SMILES

C1CC1CN2CCC34C5C(=O)CCC3(C2CC6=C4C(=C(C=C6)O)O5)O.Cl

2.1.5 Isomeric SMILES

C1CC1CN2CC[C@]34[C@@H]5C(=O)CC[C@]3([C@H]2CC6=C4C(=C(C=C6)O)O5)O.Cl

2.2 Other Identifiers

2.2.1 UNII

Z6375YW9SF

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Antaxone

2. Celupan

3. En 1639a

4. En-1639a

5. En1639a

6. Nalorex

7. Naltrexone

8. Nemexin

9. Revia

10. Trexan

2.3.2 Depositor-Supplied Synonyms

1. Naltrexone Hcl

2. 16676-29-2

3. Trexan

4. Depade

5. Antaxone

6. Revia

7. Naltrexone (hydrochloride)

8. En-1639a

9. Nih 8503

10. Celupan

11. Nemexin

12. N-cyclopropylmethyl-noroxymorphone Hydrochloride

13. Mls000069607

14. Naltrexone Hydrochloride [usp]

15. Z6375yw9sf

16. Vivitrex

17. 17-(cyclopropylmethyl)-4,5-alpha-epoxy-3,14-dihydroxy-morphinan-6-one Hydrochloride

18. Nalorex

19. Smr000058767

20. En-1639a (as Hydrochloride)

21. En 1639a

22. (4r,4as,7ar,12bs)-3-(cyclopropylmethyl)-4a,9-dihydroxy-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride

23. Naltrexone Hydrochloride (usp)

24. (4r,4as,7ar,12bs)-3-(cyclopropylmethyl)-4a,9-dihydroxy-2,3,4,4a,5,6-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7(7ah)-one Hydrochloride

25. Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, Hydrochloride (1:1), (5alpha)-

26. Ccris 1168

27. Einecs 240-723-0

28. Unii-z6375yw9sf

29. Naltrel

30. Naltrexone.hcl

31. Naltrexone Depot

32. Prestwick_348

33. Mfcd00069324

34. (5alpha)-17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

35. Revia (tn)

36. Xr-ntx

37. (4r,4as,7ar,12bs)-3-(cyclopropylmethyl)-4a,9-dihydroxy-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one;hydrochloride

38. Opera_id_1828

39. Naltrexone Monohydrochloride

40. Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-alpha-epoxy-3,14-dihydroxy-, Hydrochloride

41. Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, Hydrochloride, (5-alpha)-

42. Schembl37713

43. Mls001076516

44. Mls002153483

45. Mls002695940

46. Cyto-205

47. Chembl1201149

48. Dtxsid50937236

49. Pti-901

50. Chebi:134687

51. Bcp08343

52. Naltrexone Hydrochloride [mi]

53. S2103

54. Vp-004

55. Akos015994597

56. Ccg-268383

57. Cs-0763

58. Hs-0003

59. Nc00693

60. 17-cyclopropylmethyl)-4,5alpha-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

61. Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-alpha-oxy-3,14-dihydoxy-, Hydrochloride

62. Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, Hydrochloride, (5alpha)-

63. Naltrexone Hydrochloride [mart.]

64. Naltrexone Hydrochloride [vandf]

65. Naltrexone Hydrochloride [who-dd]

66. Bn164635

67. Hy-76710

68. Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, Hydrochloride, (5.alpha.)-

69. N1176

70. Naltrexone Hydrochloride [green Book]

71. Sw196619-3

72. Naltrexone Hydrochloride [orange Book]

73. D02095

74. Embeda Component Naltrexone Hydrochloride

75. H10489

76. Naltrexone Hydrochloride [ep Monograph]

77. Naltrexone Hydrochloride [usp Monograph]

78. Troxyca Component Naltrexone Hydrochloride

79. 676n292

80. Contrave Component Naltrexone Hydrochloride

81. Naltrexone Hydrochloride Component Of Embeda

82. Naltrexone Hydrochloride Component Of Troxyca

83. Naltrexone Hydrochloride Component Of Contrave

84. Q27096434

85. Z1558290144

86. Naltrexone Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

87. Naltrexone Hydrochloride, European Pharmacopoeia (ep) Reference Standard

88. (5a)-17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-morphinan-6-one Hydrochloride

89. 17-(cyclopropylmethyl)-3,14-dihydroxy-4,5alpha-epoxymorphinan-6-one Hydrochloride

90. 17-cyclopropylmethyl)-4,5.alpha.-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

91. (1s,5r,13r,17s)-4-(cyclopropylmethyl)-10,17-dihydroxy-12-oxa-4-azapentacyclo[9.6.1.0^{1,13}.0^{5,17}.0^{7,18}]octadeca-7(18),8,10-trien-14-one Hydrochloride

92. (4r,4as,7ar,12bs)-3-(cyclopropylmethyl)-4a,9-dihydroxy-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydron;chloride

93. (5alpha,17r)-17-(cyclopropylmethyl)-3,14-dihydroxy-6-oxo-4,5-epoxymorphinan-17-ium Chloride

94. Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, (5.alpha.)-, Hydrochloride (1:1)

2.4 Create Date

2005-08-08

3 Chemical and Physical Properties

Molecular Formula	C₂₀H₂₄ClNO₄
Molecular Weight	377.9 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	2
Exact Mass	377.1393859 g/mol
Monoisotopic Mass	377.1393859 g/mol
Topological Polar Surface Area	70 Å²
Heavy Atom Count	26
Formal Charge	0
Complexity	621
Isotope Atom Count	0
Defined Atom Stereocenter Count	4
Undefined Atom Stereocenter Count	0
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 6
Drug Name	Naltrexone hydrochloride
PubMed Health	Naltrexone
Drug Classes	Ethanol Dependency, Opioid Dependency, Toxicology-Antidote Agent
Drug Label	Naltrexone hydrochloride, an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethy...
Active Ingredient	Naltrexone hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	25mg; 100mg; 50mg
Market Status	Prescription
Company	Accord Hlthcare; Mallinckrodt; Sun Pharma Global; Elite Labs; Barr

2 of 6
Drug Name	Revia
PubMed Health	Naltrexone
Drug Classes	Ethanol Dependency, Opioid Dependency, Toxicology-Antidote Agent
Drug Label	REVIA (naltrexone hydrochloride tablets USP), an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced...
Active Ingredient	Naltrexone hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	50mg
Market Status	Prescription
Company	Teva Womens

3 of 6
Drug Name	Vivitrol
Active Ingredient	Naltrexone
Dosage Form	For suspension, extended release
Route	Intramuscular
Strength	380mg/vial
Market Status	Prescription
Company	Alkermes

4 of 6
Drug Name	Naltrexone hydrochloride
PubMed Health	Naltrexone
Drug Classes	Ethanol Dependency, Opioid Dependency, Toxicology-Antidote Agent
Drug Label	Naltrexone hydrochloride, an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethy...
Active Ingredient	Naltrexone hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	25mg; 100mg; 50mg
Market Status	Prescription
Company	Accord Hlthcare; Mallinckrodt; Sun Pharma Global; Elite Labs; Barr

5 of 6
Drug Name	Revia
PubMed Health	Naltrexone
Drug Classes	Ethanol Dependency, Opioid Dependency, Toxicology-Antidote Agent
Drug Label	REVIA (naltrexone hydrochloride tablets USP), an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced...
Active Ingredient	Naltrexone hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	50mg
Market Status	Prescription
Company	Teva Womens

6 of 6
Drug Name	Vivitrol
Active Ingredient	Naltrexone
Dosage Form	For suspension, extended release
Route	Intramuscular
Strength	380mg/vial
Market Status	Prescription
Company	Alkermes

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Alcohol Deterrents

Substances interfering with the metabolism of ethyl alcohol, causing unpleasant side effects thought to discourage the drinking of alcoholic beverages. Alcohol deterrents are used in the treatment of alcoholism. (See all compounds classified as Alcohol Deterrents.)

Narcotic Antagonists

Agents inhibiting the effect of narcotics on the central nervous system. (See all compounds classified as Narcotic Antagonists.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Opioid Antagonists [MoA]; Opioid Antagonist [EPC]

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 90MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG

USFDA APPLICATION NUMBER - 200063

DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**