naltrexone - Profile

What are the generic drug sources for naltrexone and what is the scope of freedom to operate?

Naltrexone is the generic ingredient in five branded drugs marketed by Teva Pharms Usa Inc, Alkermes, Accord Hlthcare, Barr, Chartwell, Elite Labs, Novitium Pharma, Specgx Llc, Sun Pharm, Teva Womens, and Pfizer, and is included in eleven NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Naltrexone has eighteen patent family members in eleven countries.

There is one tentative approval for this compound.

Summary for naltrexone

International Patents:	18
US Patents:	2
Tradenames:	5
Applicants:	11
NDAs:	11
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for naltrexone

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for naltrexone

Constraining patent/regulatory exclusivity:

7,919,499

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.

Generic filers with tentative approvals for NALTREXONE

Applicant	Application No.	Strength	Dosage Form
		8MG/90MG	TABLET, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for NALTREXONE

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 naltrexone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa Inc	NALTREXONE	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	213195-001	Jul 6, 2023		DISCN	No	No
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006		RX	Yes	Yes	7,919,499
Accord Hlthcare	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	091205-001	Aug 17, 2011	AB	RX	No	No
Barr	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	074918-001	May 8, 1998	AB	RX	No	No
Chartwell	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	207905-001	Jul 21, 2017	AB	RX	No	No
Elite Labs	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	075274-001	May 26, 1999	AB	RX	No	No
Novitium Pharma	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	075434-001	Mar 8, 2000		DISCN	No	No

Expired US Patents for naltrexone

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	6,194,006
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	6,596,316
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	6,331,317
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	5,792,477
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	6,264,987
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	6,403,114

International Patents for naltrexone

Country	Patent Number	Title	Estimated Expiration
China	1946353	Naltrexone long acting formulations and methods of use
New Zealand	549976	Naltrexone long acting formulations and methods of use
South Africa	200608563	Naltrexone long acting formulations and methods of use
China	103251597	Naltrexone long acting formulations and methods of use
South Korea	20090050111	NALTREXONE LONG ACTING FORMULATIONS AND METHODS OF USE
Japan	2011225600	NALTREXONE LONG ACTING FORMULATION AND METHOD OF USE
Japan	5426094

Supplementary Protection Certificates for naltrexone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	132017000142109	Italy		PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
2316456	2017/059	Ireland		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		PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND 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	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	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

Naltrexone: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary
Naltrexone, originally approved by the FDA in 1984 for opioid dependence, has diversified applications including alcohol use disorder and off-label uses such as weight management, making it a focal point for pharmaceutical investors. Its patent landscape, approval timeline, market opportunities, competitive environment, and regulatory considerations shape its investment prospects. This report analyzes current market dynamics, forecasted growth, and strategic perspectives for stakeholders considering exposure to naltrexone.

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1. Introduction to Naltrexone
Naltrexone is an opioid antagonist, primarily used to block the effects of opioids, with secondary applications in alcohol dependence. Its mechanism inhibits the euphoric effects, reducing cravings. Marketed under brand names including Revia and Vivitrol, naltrexone's formulations include oral tablets and extended-release injectable forms.

2. Patent and Regulatory Status

• Patents and Exclusivity: The original patent for oral naltrexone expired around 2000, opening generic competition (1). However, the extended-release injectable formulation (Vivitrol) held exclusivity until 2022 in major markets.
• Regulatory Approvals: Approved by FDA in 1984; extended-release injection approved in 2010. Regulatory pathways for off-label uses remain complex, influencing market penetration.

3. Current Market Size and Revenue Streams

Market Segment	2022 Revenue (USD millions)	Growth Rate (CAGR 2022-2028)	Notes
Opioid Use Disorder (OUD)	$200	5%	Vivitrol dominant, generic versions increasing
Alcohol Use Disorder (AUD)	$150	6%	Growing off-label use, regulatory challenges
Weight Management & Other Uses	$50	8%	Early-stage, investigational or off-label use
Total	$400	5.8%

Sources: IQVIA (2022), MarketResearch.com (2022)

4. Market Dynamics and Drivers

Driver	Impact	Evidence & Trends
Opioid Epidemic	Sustains demand for OUD treatments	US opioid crisis led to increased adoption of injectable naltrexone
Expanded Label Indications	Broader applications increase revenue streams	Approval for AUD in 2018; off-label uses expanding
Generic Competition	Reduces price and margins for original formulations	Multiple generics for oral naltrexone since early 2000s
Regulatory Innovations	Accelerated approvals and expanded indications	Orphan drug designation for Vivitrol in specific populations
COVID-19 Impact	Disrupted supply chains; increased telemedicine use	Accelerated adoption of injectable formulations for remote access

5. Competitive Landscape

Competitor / Product	Type	Market Share (2022)	Key Differentiators	Pipeline Status
Vivitrol (Alkermes)	Brand Injectable	60%	Proprietary extended-release formulation	No new versions announced
Generic Naltrexone	Oral / Injectable	35%	Lower price point	Continuous innovation
Other formulations (e.g., compounded)	Off-label products	5%	Customizable dosing	Regulatory scrutiny

Note: Market share estimates derive from IQVIA (2022).

6. Financial Trajectory and Investment Considerations

• Revenue Projections (2023-2028)	Year	Revenue Estimate (USD millions)	Drivers	Risks
  2023	$420	Market growth, expanded access	Market saturation, generic erosion
  2024	$445	New healthcare initiatives	Regulatory hurdles for off-label expansion
  2025	$470	Increasing awareness, new indications	Competition, patent expirations
  2026	$500	Broader acceptance, telemedicine trends	Pricing pressure
  2027	$530	Clinical validation of off-label uses	Patent cliffs, substitute therapies
  2028	$560	Mature market, new formulations	Generic market dominance

• Profitability Outlook
  Margins are under pressure from generics; however, proprietary formulations like Vivitrol sustain higher margins. Revenue growth stems chiefly from increased adoption and expanded indications, offset by pricing pressures and regulatory challenges.

7. Strategic Factors for Investors

Factor	Implications	Strategies
Patent Expirations	Intensifies generic competition, lowers prices	Focus on brand formulations with remaining exclusivity
Expansion of Indications	Enhances market size; regulatory hurdles exist	Invest in R&D for new uses; align with regulatory pathways
Market Penetration in Emerging Economies	Growth opportunity; regulatory variability	Local partnerships; adapt formulations to regional regulations
Off-label Use and Investigational Uses	Potential upside; lacks regulatory approval	Support clinical trials; monitor reimbursement policies

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8. Comparative Analysis with Similar Therapeutics

Therapeutic Class	Main Drugs	Market Launch Year	Key Differentiators	Revenue (2022)
Opioid Dependence Treatment	Methadone, Buprenorphine	1960s-2000s	Different mechanisms; regulatory controls	$4.5 billion
Alcohol Use Disorder	Disulfiram, Acamprosate	1950s-2004	Varied efficacy; side effect profiles	$600 million
Over-the-Counter Supplements	Naltrexone (off-label)	N/A	Limited regulatory oversight	Not applicable

The dominance of Vivitrol over other options underscores the importance of proprietary formulations and clinical positioning.

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9. Regulatory and Policy Considerations

Aspect	Impact on Investment Strategy	Current Policy Environment
Reimbursement Policies	Affect adoption rates; favorable policies boost sales	CMS and private insurers increasingly cover Vivitrol treatments
Off-label Use Regulations	Limit or facilitate off-label prescribing	Ongoing debates; regulatory flexibility in certain jurisdictions
Access to Medicaid/Insurance	Critical for market expansion	Medicaid expansion states show higher utilization

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10. Future Outlook and Innovation Trajectories

Area	Expected Developments	Potential Impact
Novel Delivery Systems	Transdermal patches, implants	Improved adherence, expanded patient population
Combination Therapies	Naltrexone with mood stabilizers or anti-addiction agents	Broadened therapeutic use, increased sales
Personalized Medicine	Pharmacogenomics to identify responders	Higher efficacy, tailored treatment, better outcomes

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Key Takeaways

• Naltrexone's market remains viable, with revenues approximating $400 million globally as of 2022, driven primarily by Vivitrol but challenged by generic erosion.
• Market growth is projected at ~5.8% CAGR through 2028, influenced by expanding indications, technological advances, and regulatory adaptations.
• The primary opportunities exist in broadening approved uses, developing novel formulations, and expanding into emerging markets, despite looming patent expirations.
• Competitive pressures from generics necessitate strategic emphasis on proprietary formulations and combination therapies.
• Regulatory policies favor increased reimbursement and utilization, especially within the opioid and alcohol dependency landscapes.

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FAQs

1. What are the main drivers of growth for naltrexone beyond opioid dependence?
Broadened indication approvals for alcohol use disorder, emerging off-label applications such as weight management, and technological advancements in delivery systems are primary growth drivers.

2. How does patent expiration impact naltrexone's revenue potential?
Patent expiration, around 2000 for oral formulations and 2022 for the extended-release injectable, introduces intense generic competition, exerting downward pressure on prices and margins.

3. What regulatory hurdles could hinder future commercialization?
Off-label use restrictions, challenges in gaining approvals for new indications, and reimbursement policies may limit growth trajectories.

4. How do competitors position against naltrexone?
Competitors offer alternative therapies like methadone and buprenorphine for OUD, and disulfiram or acamprosate for AUD. Proprietary formulations and combination treatments serve as differentiators.

5. What is the long-term outlook for investors in naltrexone?
Investors should consider the potential for growth through indication expansion, innovations in delivery, and market penetration, balanced against generic competition and regulatory uncertainties.

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References

[1] U.S. Food and Drug Administration. (2000). "Patents and Exclusivity for Naltrexone."
[2] IQVIA Institute. (2022). "Global Trends in Addiction Treatment Market."
[3] MarketResearch.com. (2022). "Naltrexone Market Analysis."
[4] Alkermes. (2010). "Vivitrol FDA Approval and Sales Data."
[5] Centers for Medicare & Medicaid Services. (2021). "Reimbursement Policies for Addiction Treatments."