You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Harvard Business School
McKesson
Merck
Johnson and Johnson
McKinsey
Colorcon

Last Updated: January 16, 2021

DrugPatentWatch Database Preview

VIVITROL Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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 are seven patents protecting this drug.

This drug has eighty-nine patent family members in twenty-eight countries.

The generic ingredient in VIVITROL is naltrexone. There are nineteen drug master file entries for this compound. Additional details are available on the naltrexone profile page.

US ANDA Litigation and 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.

Indicators of Generic Entry

< Available with Subscription >

  Start Trial

Drug patent expirations by year for VIVITROL
Drug Prices for VIVITROL

See drug prices for VIVITROL

Drug Sales Revenue Trends for VIVITROL

See drug sales revenues for VIVITROL

Recent Clinical Trials for VIVITROL

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

SponsorPhase
Ho Chi Minh City CDCPhase 2
The Wistar InstitutePhase 2
IMEA ParisPhase 2

See all VIVITROL clinical trials

Paragraph IV (Patent) Challenges for VIVITROL
Tradename Dosage Ingredient NDA Submissiondate
VIVITROL FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR naltrexone 021897 2020-06-18

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   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   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 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   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 VIVITROL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Dow
AstraZeneca
Medtronic
Express Scripts
Colorcon

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 verification 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.