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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Queensland Health
Cerilliant
McKinsey
UBS
QuintilesIMS
Argus Health
Harvard Business School

Generated: April 27, 2018

DrugPatentWatch Database Preview

Naltrexone - Generic Drug Details

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What are the generic 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.

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

There are nineteen drug master file entries for naltrexone. One supplier is listed for this compound.
Summary for naltrexone
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
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-001 Aug 19, 2016 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-005 Aug 19, 2016 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-006 Aug 19, 2016 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer Inc TROXYCA ER naltrexone hydrochloride; oxycodone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 207621-005 Aug 19, 2016 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 ➤ Try a Free Trial ➤ Try a Free Trial
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for naltrexone

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,861,016 Apparatus and method for preparing microparticles ➤ Try a Free Trial
7,300,671 Method and apparatus for preparing microparticles using in-line solvent extraction ➤ Try a Free Trial
6,540,393 Apparatus for preparing microparticles using in-line solvent extraction ➤ Try a Free Trial
7,371,406 Preparation of injectable suspensions having improved injectability ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
UBS
Argus Health
Deloitte
Mallinckrodt
Moodys
Cerilliant
Cantor Fitzgerald
Harvard Business School

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.