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Last Updated: February 2, 2023

VIVITROL Drug Patent Profile


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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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 15, 2029. This may change due to patent challenges or generic licensing.

Annual sales in 2019 were $220mm indicating the motivation for generic entry (peak sales were $257mm in 2016).

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

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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

DrugPatentWatch® Estimated 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.

Recent Clinical Trials for VIVITROL

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

SponsorPhase
Inventage Lab., Inc.Phase 1
Baylor College of MedicinePhase 3
University of Texas Southwestern Medical CenterPhase 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VIVITROL is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VIVITROL

Naltrexone long acting formulations and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PREVENTION OF RELAPSE TO OPIOID DEPENDENCE, FOLLOWING OPIOID DETOXIFICATION

Naltrexone long acting formulations and methods of use
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ALCOHOL DEPENDENCE

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 See Plans and Pricing See Plans and Pricing
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 See Plans and Pricing See Plans and Pricing
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 See Plans and Pricing See Plans and Pricing
Alkermes VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897-001 Apr 13, 2006 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for VIVITROL

When does loss-of-exclusivity occur for VIVITROL?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 05239989
Estimated Expiration: See Plans and Pricing

Canada

Patent: 63086
Estimated Expiration: See Plans and Pricing

China

Patent: 46353
Estimated Expiration: See Plans and Pricing

Patent: 3251597
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 40120
Estimated Expiration: See Plans and Pricing

Patent: 86269
Estimated Expiration: See Plans and Pricing

Japan

Patent: 26094
Estimated Expiration: See Plans and Pricing

Patent: 07533738
Estimated Expiration: See Plans and Pricing

Patent: 11225600
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 9976
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 70257
Estimated Expiration: See Plans and Pricing

Patent: 06137349
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0608563
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 070005722
Estimated Expiration: See Plans and Pricing

Patent: 090050111
Estimated Expiration: See Plans and Pricing

United Kingdom

Patent: 04637
Estimated Expiration: See Plans and Pricing

Patent: 98895
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country Patent Number Title Estimated Expiration
Japan 2006249440 MICROPARTICLE See Plans and Pricing
Australia 2001255463 See Plans and Pricing
Australia 3117800 See Plans and Pricing
Spain 2391315 See Plans and Pricing
Spain 2286118 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VIVITROL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 LUC00054 Luxembourg See Plans and Pricing 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 See Plans and Pricing 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
2316456 2017/059 Ireland See Plans and Pricing 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 132017000142109 Italy See Plans and Pricing PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
2316456 2017C/064 Belgium See Plans and Pricing PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.