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
Summary for VIVITROL
International Patents: | 18 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 45 |
Clinical Trials: | 83 |
Patent Applications: | 7,999 |
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 |
What excipients (inactive ingredients) are in VIVITROL? | VIVITROL excipients list |
DailyMed Link: | VIVITROL at DailyMed |



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
Sponsor | Phase |
---|---|
Inventage Lab., Inc. | Phase 1 |
Baylor College of Medicine | Phase 3 |
University of Texas Southwestern Medical Center | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for VIVITROL
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 |