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Generated: November 18, 2018

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Naltrexone - Generic Drug Details

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What are the generic drug sources for naltrexone and what is the scope of naltrexone freedom to operate?

Naltrexone is the generic ingredient in four branded drugs marketed by Alkermes, Accord Hlthcare, Apotex Inc, Barr, Elite Labs, Fosun Pharma, Specgx Llc, Sun Pharma Global, Teva Womens, and Pfizer Inc, and is included in ten NDAs. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for naltrexone. One supplier is listed for this compound.

Medical Subject Heading (MeSH) Categories for naltrexone
Synonyms for naltrexone
(-)-Naltrexone
(-)naltrexone
(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-7,9,11(18)-trien-14-one
(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
(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
(1S,5R,13R,17S)-4-(CYCLOPROPYLMETHYL)-10,17-DIHYDROXY-12-OXA-4-AZAPENTACYCLO[9.6.1.0(1),(1)(3).0?,(1)?.0?,(1)?]OCTADECA-7(18),8,10-TRIEN-14-ONE
(4R,4aS,7aR,12bS)-3-(cyclopropylmethyl)-4a,9-bis(oxidanyl)-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one;hydrochloride
(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
(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
16590-41-3
17-(Cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxmorphinan-6-one, (5.alpha.)-
17-(Cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxymorphinan-6-one
17-(Cyclopropylmethyl)-4,5alpha-epoxy-3,14-dihydroxymorphinan-6-one
3,14-dihydroxy-17-(cyclopropylmethyl)-4,5alpha-epoxymorphinan-6-one
5S6W795CQM
88088-EP2270005A1
88088-EP2275420A1
88088-EP2298761A1
88088-EP2298776A1
88088-EP2305648A1
AB00174152_17
AB00174152-14
AK192538
AKOS015994596
AN-12941
BDBM50000787
BDBM60212
BIDD:GT0405
BPBio1_000146
BRD-K88172511-310-03-8
BRN 3596648
BSPBio_000132
C07253
CAS-16590-41-3
CCRIS 3506
Celupan
CHEBI:7465
CHEMBL19019
cid_5485201
CS-0880
cyclopropylmethyl(dihydroxy)[?]one
cyclopropylmethylnoroxymorphone
D05113
D0PG8O
DB00704
Depotrex
DQCKKXVULJGBQN-XFWGSAIBSA-N
DSSTox_CID_26313
DSSTox_GSID_46313
DSSTox_RID_81532
DTXSID4046313
EINECS 240-649-9
EN-1639A [AS HYDROCHLORIDE]
FT-0696752
GTPL1639
HMS2089O11
HS-0002
HSDB 6750
HY-76711
IBS therapy, Pain Therapeutics
Irritable bowel syndrome therapy, Pain Therapeutics
LS-92094
MCULE-7032963403
MFCD00242996
MolPort-004-920-221
Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-alpha-epoxy-3,14-dihydroxy-
Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, (5alpha)-
Morphinan-6-one,17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, (5a)-
MorViva
N-Cyclopropylmethyl-14-hydroxydihydromorphinone
N-Cyclopropylmethylnoroxymorphone
Naltrel
Naltrexon
Naltrexona
Naltrexona [INN-Spanish]
Naltrexone (low-dose), Pain Therapeutics
Naltrexone (once-monthly controlled-release, Medisorb), Alkermes
Naltrexone (polymer microcapsule depot, opioid addiction/alcohol dependency), Biotek
naltrexone (ReVia)
Naltrexone (sustained release), DAS
Naltrexone (sustained release), elbion
Naltrexone (transdermal, alcohol/opioid dependence), Syntropharma
Naltrexone (USAN/INN)
Naltrexone [USAN:BAN:INN]
Naltrexone [USAN:INN:BAN]
Naltrexone base anhydrous
Naltrexone Depot
Naltrexone depot (injectable suspension), DrugAbuse Sciences
Naltrexone depot (injectable suspension), elbion
Naltrexone hydrochloride
Naltrexone solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Naltrexonum
Naltrexonum [INN-Latin]
NCGC00024427-03
NCGC00024427-04
NCGC00024427-05
NCGC00162274-02
Nemexin
Opioid antagonists (irritable bowel syndrome), Pain Therapeutics
PDSP2_000847
PL006614
Prestwick0_000116
Prestwick1_000116
Prestwick2_000116
Prestwick3_000116
PTI-555
PTI-901
PubChem24168
ReVia
SC-94535
SCHEMBL34681
SMP1_000206
SPBio_002071
Tox21_112007
Tox21_112007_1
UM-792
UNII-5S6W795CQM
Vivitrex
Vivitrol
Vivitrol (TN)
W-5099
XR-NTX
ZINC1773

US Patents and Regulatory Information for naltrexone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 091205-001 Aug 17, 2011 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Fosun Pharma NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 075434-001 Mar 8, 2000 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for naltrexone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 ➤ Sign Up ➤ Sign Up
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 ➤ Sign Up ➤ Sign Up
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Merck
McKinsey
Argus Health
US Department of Justice
Moodys
Citi
QuintilesIMS
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.