VIVITROL Drug Patent Profile

Which patents cover Vivitrol, and when can generic versions of Vivitrol launch?

Vivitrol is a drug marketed by Alkermes and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has eighteen patent family members in eleven 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.

DrugPatentWatch^® Generic Entry Outlook for Vivitrol

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (naltrexone), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for VIVITROL

International Patents:	18
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	83
Patent Applications:	4,888
Drug Prices:	Drug price information for VIVITROL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIVITROL
What excipients (inactive ingredients) are in VIVITROL?	VIVITROL excipients list
DailyMed Link:	VIVITROL at DailyMed

See drug prices for VIVITROL

See drug sales revenues for VIVITROL

Recent Clinical Trials for VIVITROL

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

Sponsor	Phase
Inventage Lab., Inc.	Phase 1
Baylor College of Medicine	Phase 3
University of Texas Southwestern Medical Center	Phase 2

See all VIVITROL clinical trials

Paragraph IV (Patent) Challenges for VIVITROL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIVITROL	Extended-release Injectable Suspension	naltrexone	380 mg/vial	021897	1	2020-06-18

US Patents and Regulatory Information for VIVITROL

VIVITROL is protected by two US patents.

Patents protecting 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

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

See the table below for patents covering VIVITROL around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2563086	PROCEDE ET SYSTEME D'INVESTIGATION ANONYME ETENDUE BASEE SURDES FAITS ET D'ETABLISSEMENT DE RAPPORTS A BASE DE FAITS ET D'ACCES SELECTIF AUX RESULTATS ET RAPPORTS (NALTREXONE LONG ACTING FORMULATIONS AND METHODS OF USE)
Canada	2390284	APPAREIL ET PROCEDE DE PREPARATION DE MICROPARTICULES (APPARATUS AND METHOD FOR PREPARING MICROPARTICLES)
Japan	4903344
Slovenia	1283699
Portugal	1925297
European Patent Office	1140029	PREPARATION DE MICROPARTICULES A PROFIL RETARD (PREPARATION OF MICROPARTICLES HAVING A SELECTED RELEASE PROFILE)

Supplementary Protection Certificates for VIVITROL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	132017000142109	Italy		PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
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	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	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	SPC/GB17/078	United Kingdom		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.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330