DrugPatentWatch Database Preview

VIVITROL Drug Profile

« Back to Dashboard

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 thirteen patents protecting this drug.

This drug has one hundred and thirteen patent family members in twenty-eight 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.

US ANDA Litigation and Generic Entry Outlook for Vivitrol

Vivitrol was eligible for patent challenges on December 31^st, 1968.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 19^th, 2020. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch.

Summary for VIVITROL

International Patents:	113
US Patents:	13
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	32
Clinical Trials:	63
Patent Applications:	5,869
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VIVITROL
Drug Sales Revenues:	Drug sales revenues for VIVITROL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIVITROL
DailyMed Link:	VIVITROL at DailyMed

See drug prices for VIVITROL

See drug sales revenues for VIVITROL

Generic Entry Opportunity Date for VIVITROL

NDA:

021897

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.

Recent Clinical Trials for VIVITROL

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

Sponsor	Phase
CARESTAR Foundation	Phase 4
University of California, San Francisco	Phase 4
Frances R Levin	Phase 2

See all VIVITROL clinical trials

Recent Litigation for VIVITROL

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Alkermes Pharma Ireland Limited v. Luye Pharma Group Ltd.	2019-07-17
Purdue Pharmaceutical v. Actavis Elizabeth LLC	2015-05-13

See all VIVITROL litigation

PTAB Litigation

Petitioner	Date
Amneal Pharmaceuticals LLC	2018-04-20
Luye Pharma Group Ltd.	2016-05-31

See all VIVITROL litigation

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

(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

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 (TN)

W-5099

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			Y
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006		RX	Yes	Yes			Y
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006		RX	Yes	Yes			Y
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006		RX	Yes	Yes			Y
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006		RX	Yes	Yes			Y
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006		RX	Yes	Yes			Y

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
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006

International Patents for VIVITROL

Country	Patent Number	Estimated Expiration
Denmark	1754469
Japan	2003513905
European Patent Office	3095442
Japan	2011225600
Cyprus	1110403
Russian Federation	2006137349

Supplementary Protection Certificates for VIVITROL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	2017C/064	Belgium		PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2316456	1790064-8	Sweden		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
2316456	LUC00054	Luxembourg		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; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2316456	17C1058	France		PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456	2017/059	Ireland		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