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Serving hundreds of leading biopharmaceutical companies globally:

Dow
US Army
Baxter
AstraZeneca
Fish and Richardson
Express Scripts
Teva
Covington
Cantor Fitzgerald

Generated: July 17, 2018

DrugPatentWatch Database Preview

VIVITROL Drug Profile

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When do Vivitrol patents expire, and when can generic versions of Vivitrol launch?

Vivitrol is a drug marketed by Alkermes and is included in one NDA. There are sixteen patents protecting this drug.

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

The generic ingredient in VIVITROL is naltrexone. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the naltrexone profile page.
Drug patent expirations by year for VIVITROL
Generic Entry Opportunity Date for VIVITROL
Generic Entry Date for VIVITROL*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Medical Subject Heading (MeSH) Categories for VIVITROL
Synonyms for VIVITROL
(-)-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
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 (TN)
W-5099
XR-NTX
ZINC1773

US Patents and Regulatory Information for VIVITROL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 RX Yes Yes ➤ 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
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ 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 VIVITROL

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
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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Non-Orange Book US Patents for VIVITROL

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
7,510,730 Apparatus and method for preparing microparticles using in-line solvent extraction ➤ Sign Up
6,540,393 Apparatus for preparing microparticles using in-line solvent extraction ➤ Sign Up
7,371,406 Preparation of injectable suspensions having improved injectability ➤ Sign Up
6,861,016 Apparatus and method for preparing microparticles ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Medtronic
Deloitte
Accenture
Citi
Boehringer Ingelheim
Dow
AstraZeneca
Covington

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