VIVITROL Drug Patent Profile

Name: VIVITROL Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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

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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Summary for VIVITROL

International Patents:	18
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	86
Patent Applications:	2,857
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

Drug patent expirations by year for VIVITROL

Recent Clinical Trials for VIVITROL

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

Sponsor	Phase
National Institute on Drug Abuse (NIDA)	PHASE1
Cenexel JBR	PHASE1
Fast-Track Drugs & Biologics, LLC	PHASE1

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.

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Glossary

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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	7,919,499	⤷ Start Trial				⤷ 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

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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	6,395,304	⤷ Start Trial
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	7,799,345	⤷ Start Trial
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	6,537,586	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for VIVITROL

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

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Country	Patent Number	Title	Estimated Expiration
Malaysia	118174	PROCESS FOR THE PREPARATION OF MICROPARTICLES	⤷ Start Trial
Australia	5546301		⤷ Start Trial
Spain	2284776		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for VIVITROL

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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	SPC/GB17/078	United Kingdom	⤷ 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.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330
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

Market Dynamics and Financial Trajectory of VIVITROL (Naltrexone for Extended-Release Injectable Suspension)

Last updated: April 22, 2026

What is the current market position of VIVITROL?

VIVITROL is an extended-release injectable form of naltrexone produced by Alkermes. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of alcohol dependence, opioid dependence, and for mental health management. Since its approval in 2010, VIVITROL has maintained a niche in addiction treatment, particularly where adherence to oral medication is challenging.

What is the size of the VIVITROL market?

The global addiction treatment market was valued at $5.3 billion in 2021 and is projected to reach approximately $9.1 billion by 2028, growing at a compound annual growth rate (CAGR) of 8.4% (Fortune Business Insights, 2022). VIVITROL’s contribution is estimated at 8-10% of total pharmacologic treatments for alcohol and opioid dependence.

Sales Revenue (2022–2023)

Year	Revenue (USD millions)	Notes
2022	350	Steady growth driven by increased demand for injectable treatments.
2023	385	Slight uptick owing to expanded indications and formulary access.

Forecasts suggest revenues could reach $500 million by 2026, assuming continued adoption.

How does VIVITROL compare with its competitors?

Drug	Drug Class	Market Penetration (2022)	Approval Dates	Unique Selling Point
VIVITROL	Naltrexone (extended-release)	80% of injectable treatments	Approved in 2010 (FDA)	Once-monthly administration, proven adherence benefits
Vivitrol (oral)	Naltrexone (oral)	10%	1984	Cost-effective, simpler distribution
Suboxone	Buprenorphine/Naloxone	6%	2002	Partial opioid agonist, ease of use for detox
Methadone	Full opioid agonist	4%	Approved via various protocols	Long history, high efficacy but regulatory restrictions

VIVITROL holds a dominant position in injectable formulations with a 70-80% share, especially in healthcare systems emphasizing long-term adherence.

What are the drivers and barriers influencing market growth?

Drivers

Increased adoption for opioid and alcohol dependence: The opioid epidemic has increased the demand for long-acting interventions.
Regulatory endorsements: FDA approval and subsequent guidelines promote prescribing VIVITROL for opioid and alcohol use disorder.
Patient adherence advantage: Once-monthly injections mitigate compliance issues linked to daily oral medication.
Expanded indications: Ongoing research into relapse prevention and psychiatric conditions could broaden use.

Barriers

High per-dose cost: Price per injection exceeds $1,200, limiting access in certain markets.
Injection site reactions: Some patients experience discomfort, affecting acceptance.
Limited healthcare provider familiarity: Some providers prefer oral alternatives due to familiarity or reimbursement constraints.
Reimbursement challenges: Insurance coverage varies, affecting patient access.

What are the recent and upcoming regulatory and clinical developments?

FDA label expansion (2021): Clarified use in adolescent populations aged 16 and older for opioid dependence.
Ongoing trials: Research includes VIVITROL’s efficacy in preventing relapse in co-occurring psychiatric disorders and in adolescents.
EMA considerations: European approval processes are ongoing, with commercialization efforts targeting the continent.

What is the future financial trajectory?

Projected revenue growth hinges on several factors:

Market penetration expansion: Educating providers and increasing insurance reimbursement could grow sales.
New indications: Approval for additional psychiatric conditions might diversify revenue streams.
Pricing strategies: Adjustments to improve affordability could boost volume.

Assuming a conservative CAGR of 8% from 2023 to 2026, revenues may reach approximately $500 million. Market share gains depend on competitive positioning and regulatory success in new territories.

Summarized Risks and Opportunities

Risks	Opportunities
Price sensitivity and reimbursement hurdles	Broader indications and aging populations with comorbidities
Competition from emerging therapies	Partnership strategies with health systems and payers
Regulatory delays in international markets	Adoption in criminal justice and prison settings

Key Takeaways

VIVITROL maintains a solid position within the opioid and alcohol dependence markets, driven by its once-monthly dosing and adherence benefits. Revenue growth is anticipated but constrained by high costs and reimbursement issues. Expansion into new indications and markets could improve long-term outlooks. Competitive challenges include emerging therapies and provider familiarity.

FAQs

1. What factors most influence VIVITROL’s market growth?
Market growth is primarily driven by increasing demand due to the opioid epidemic, greater provider awareness, expanded indications, and improved reimbursement policies.

2. How does the cost of VIVITROL compare to oral alternatives?
A VIVITROL injection costs around $1,200-$1,300 per dose, whereas oral naltrexone is roughly $20-$50 for a monthly supply. Cost barriers affect adoption, especially outside the U.S.

3. Are there notable clinical trial developments for VIVITROL?
Yes. Trials are ongoing for relapse prevention in psychiatric comorbidities and adolescent populations, potentially broadening its approved uses.

4. How does VIVITROL’s reimbursement landscape look globally?
Reimbursement varies widely. In the U.S., Medicaid and private insurers often cover VIVITROL; in Europe and other regions, coverage is more limited and subject to national policies.

5. What is Alkermes’ strategy to increase VIVITROL’s market share?
Alkermes focuses on expanding indications, strengthening partnerships with healthcare providers and payers, and emphasizing adherence benefits to justify pricing.

References

[1] Fortune Business Insights. (2022). Addiction Treatment Market Size, Share & Industry Analysis.
[2] U.S. Food and Drug Administration. (2010). FDA approves Vivitrol to treat alcohol dependence.
[3] Fitch Solutions. (2022). Pharmaceutical Market Outlook.
[4] Alkermes Inc. Annual Reports. (2022, 2023).

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