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Last Updated: October 22, 2019

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Naltrexone - Generic Drug Details

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What are the generic sources for naltrexone and what is the scope of 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 Pharm, Teva Womens, and Pfizer Inc, and is included in ten NDAs. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Naltrexone has one hundred and thirteen patent family members in twenty-eight countries.

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

Drug Prices for naltrexone

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Drug Sales Revenue Trends for naltrexone

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Recent Clinical Trials for naltrexone

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Boston Medical CenterPhase 2
University Hospital, Strasbourg, FrancePhase 2
US WorldMeds LLCPhase 2

See all naltrexone clinical trials

Recent Litigation for naltrexone

Identify potential future generic entrants

District Court Litigation
Case NameDate
Alkermes Pharma Ireland Limited v. Luye Pharma Group Ltd.2019-07-17
Purdue Pharmaceutical v. Actavis Elizabeth LLC2015-05-13

See all naltrexone litigation

PTAB Litigation
PetitionerDate
Amneal Pharmaceuticals LLC2018-04-20
Luye Pharma Group Ltd.2016-05-31

See all naltrexone litigation

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
(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
AKOS015994596
AN-12941
BCP07022
BDBM50000787
BDBM60212
BIDD:GT0405
BPBio1_000146
BRD-K88172511-003-21-1
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
D05113
DB00704
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
LS-92094
MCULE-7032963403
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
Naltrexon
Naltrexona
Naltrexona [INN-Spanish]
naltrexone (ReVia)
Naltrexone (USAN/INN)
Naltrexone [USAN:BAN:INN]
Naltrexone [USAN:INN:BAN]
Naltrexone base anhydrous
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
PDSP2_000847
Prestwick0_000116
Prestwick1_000116
Prestwick2_000116
Prestwick3_000116
PTI-555
PubChem24168
ReVia
SC-94535
SCHEMBL34681
SMP1_000206
SPBio_002071
Tox21_112007
Tox21_112007_1
UM-792
UNII-5S6W795CQM
US9107954, naltrexone
Vivitrex
Vivitrol
Vivitrol (TN)
W-5099
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
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-003 Aug 19, 2016 DISCN No No   Start Trial   Start Trial Y   Start Trial
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-002 Aug 19, 2016 DISCN No No   Start Trial   Start Trial Y   Start Trial
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Supplementary Protection Certificates for naltrexone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 2017/059 Ireland   Start Trial PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150326
2316456 2017C/064 Belgium   Start Trial PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2316456 1790064-8 Sweden   Start Trial PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REG. NO/DATE: EU/1/14/988 20150330
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Dow
McKesson
Moodys
AstraZeneca

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.