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:	43
Clinical Trials:	85
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

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
Element Analytics	PHASE1
Aliri Bioanalysis	PHASE1
National Institute on Drug Abuse (NIDA)	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.

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

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	6,379,703
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	7,799,345
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	5,792,477
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	6,194,006
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	6,667,061
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	6,403,114

International Patents for VIVITROL

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

Country	Patent Number	Title	Estimated Expiration
Austria	308977
Australia	773734
United Kingdom	0304637
Hong Kong	1056321
Hong Kong	1016884
China	1946353	Naltrexone long acting formulations and methods of use

Supplementary Protection Certificates for VIVITROL

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

Market Dynamics and Financial Trajectory for VIVITROL (Naltrexone Extended-Release) in the Pharmaceutical Sector

Last updated: July 27, 2025

Introduction

VIVITROL (naltrexone for extended-release injectable suspension) has established a prominent position within the pharmaceutical landscape as an innovative treatment for opioid and alcohol dependence. Its unique mechanism—delivering sustained naltrexone levels over a month—addresses critical compliance issues associated with oral therapies. As the opioid crisis persists and alcohol use disorder (AUD) remains a significant public health concern, VIVITROL's market dynamics and financial trajectory warrant meticulous analysis to inform stakeholders’ strategic decisions.

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Market Overview and Key Drivers

The global pharmaceutical market for addiction treatment is driven by diverging yet interconnected factors: rising prevalence of substance use disorders, regulatory environments, advancements in drug delivery systems, and burgeoning awareness campaigns.

Prevalence of Opioid and Alcohol Use Disorders

According to the National Institute on Drug Abuse (NIDA), over 2 million Americans suffer from opioid use disorder (OUD)—a figure projected to grow amid persistent misuse and overdose rates [1]. Concurrently, alcohol use disorder affects an estimated 15 million adults in the U.S., emphasizing the enormous demand for effective treatments like VIVITROL.

Regulatory and Reimbursement Landscape

Regulatory authorities, including the FDA, have granted VIVITROL approval for opioid dependence (2010) and alcohol dependence (2013), fueling market confidence. Reimbursement policies, particularly in the U.S., favor innovative formulations that demonstrate adherence benefits, further incentivizing payers to cover VIVITROL.

Clinical Efficacy and Patient Compliance

VIVITROL's extended-release formulation improves upon oral naltrexone's compliance challenges, reducing relapse rates by maintaining therapeutic plasma concentrations for up to a month. This clinical advantage positions it favorably over alternative therapies, driving physician adoption.

Market Competition and Product Landscape

While VIVITROL represents a leading injectable option, it faces competition from other pharmacotherapies such as mandatorily absorbed oral medications, implantable devices, and emerging digital therapeutics. Companies like Alkermes, the manufacturer of VIVITROL, maintain a competitive edge through ongoing clinical trials and pharmacovigilance, yet market contest remains fierce.

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Market Segmentation and Regional Dynamics

United States

The U.S. dominates VIVITROL’s market share, owing to extensive insurance coverage, high prevalence of OUD and AUD, and robust healthcare infrastructure. The Substance Abuse and Mental Health Services Administration (SAMHSA) emphasizes medications-assisted treatment (MAT) with medications like VIVITROL, positioning it as a frontline intervention.

Europe and Asia-Pacific

Regulatory approvals in Europe (EMA approval 2013) and emerging markets in Asia offer growth opportunities. However, cultural acceptance, healthcare system differences, and pricing policies influence market penetration.

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Financial Trajectory and Revenue Analysis

Historical Revenue Trends

Since its FDA approval in 2010, VIVITROL has experienced steady revenue growth, propelled by increasing adoption in opioid dependence treatment protocols. Reports by Alkermes, its manufacturer, indicate revenues approximating $400 million in 2022 [2].

Growth Drivers

• Expanding Indication Approvals: Recent approvals for alcohol dependence in multiple territories broaden the addressable market.
• Increasing Prescription Volumes: Rising clinician awareness and patient acceptance result in higher prescription counts.
• Market Penetration Strategies: Strategic partnerships with healthcare systems and governmental agencies drive increased coverage and utilization.

Revenue Forecasts

Industry projections estimate a compound annual growth rate (CAGR) of 8–10% in the VIVITROL segment over the next five years, contingent on market expansion, payer coverage, and competitive dynamics [3].

Cost and Pricing Considerations

VIVITROL's premium pricing—typically around $1,000 per dose—reflects its advanced formulation. Cost containment pressures and reimbursement negotiations will influence net revenues. Economies of scale and generic competition (if delayed patent expiration) could further impact profitability.

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Market Challenges and Risks

Patent Expiry and Generic Competition

VIVITROL's patent protections are slated to expire within the next 5-7 years, risking erosion of market exclusivity and pricing power. The entry of biosimilars or generic injectables could reverberate through revenue streams.

Reimbursement and Access Barriers

Despite clinical advantages, reimbursement hurdles in certain regions and insurance exclusions limit access, constraining growth.

Patient and Physician Adoption

Overcoming stigma associated with addiction medications and ensuring prescriber awareness remain critical for volume growth.

Regulatory Changes and Public Policy

Evolving regulatory environments and shifting public health priorities can influence drug approval processes and market access strategies.

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Strategic Outlook

The future trajectory for VIVITROL hinges on several factors:

• Product Pipeline Expansion: Enhancing formulations—such as implantable or simplified delivery systems—could sustain competitive advantage.
• Market Expansion Initiatives: Penetrating emerging markets with tailored pricing strategies aligns with demographic shifts and healthcare infrastructure development.
• Clinical and Real-World Evidence: Continued data demonstrating superior compliance and outcomes will fortify VIVITROL's positioning.
• Partnerships and Licensing Deals: Collaborations with healthcare providers and governments facilitate broader access.

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Key Takeaways

• VIVITROL commands a significant share of the addiction treatment market, supported by clinical efficacy and regulatory backing.
• Market growth is driven by rising prevalence of OUD and AUD, expanding approval indications, and improved patient adherence.
• Revenue forecasts project steady growth; however, patent expirations and competitive pressures pose risks.
• Cost and reimbursement landscape influences profitability; strategic positioning is vital to capitalize on upcoming opportunities.
• Ongoing innovation, geographical expansion, and evidence generation will define the drug’s financial trajectory in the medium term.

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FAQs

1. What distinguishes VIVITROL from other addiction treatments?
VIVITROL's extended-release formulation ensures monthly dosing, improving adherence compared to daily oral medications, thus reducing relapse risk in opioid and alcohol dependence.

2. How does VIVITROL perform in clinical trials?
Clinical studies demonstrate VIVITROL significantly reduces relapse rates and supports sustained abstinence compared to placebo and some oral alternatives.

3. What is the primary time horizon for VIVITROL's patent protection?
Patent protections are expected to last until approximately 2028-2030, after which generic competition may emerge.

4. How accessible is VIVITROL across different healthcare systems?
In the U.S., coverage is robust through insurance and Medicaid; penetration in other regions varies depending on healthcare policies and economic factors.

5. What are the prospects for further indication expansion?
Ongoing research aims to evaluate VIVITROL for other behavioral and psychiatric indications, potentially broadening its therapeutic scope and market size.

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Sources
[1] National Institute on Drug Abuse (NIDA). "Understanding the Opioid Crisis". 2022.
[2] Alkermes Annual Report 2022.
[3] MarketWatch. "Pharmaceuticals: Addiction Treatment Market Growth Forecast". 2022.