NALTREXONE HYDROCHLORIDE - Generic Drug Details

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

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

There are six drug master file entries for naltrexone hydrochloride. Nineteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for NALTREXONE HYDROCHLORIDE

US Patents:	2
Tradenames:	3
Applicants:	9
NDAs:	9
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	503
Patent Applications:	1,595
What excipients (inactive ingredients) are in NALTREXONE HYDROCHLORIDE?	NALTREXONE HYDROCHLORIDE excipients list
DailyMed Link:	NALTREXONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for NALTREXONE HYDROCHLORIDE

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

Sponsor	Phase
Drug Delivery Company, LLC DBA Akyso Pharmaceuticals	PHASE1
Cenexel JBR	PHASE1
Fast-Track Drugs & Biologics, LLC	PHASE1

See all NALTREXONE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for NALTREXONE HYDROCHLORIDE

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.

Pharmacology for NALTREXONE HYDROCHLORIDE

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for NALTREXONE HYDROCHLORIDE

N07BB	Drugs used in alcohol dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for NALTREXONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-005	Aug 19, 2016		DISCN	No	No	7,815,934		Y
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-004	Aug 19, 2016		DISCN	No	No	8,685,443
Accord Hlthcare	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	TABLET;ORAL	091205-001	Aug 17, 2011	AB	RX	No	No
Teva Womens	REVIA	naltrexone hydrochloride	TABLET;ORAL	018932-001	Nov 20, 1984		DISCN	Yes	No
Pfizer	TROXYCA ER	naltrexone hydrochloride; oxycodone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	207621-004	Aug 19, 2016		DISCN	No	No	7,815,934		Y

Market Dynamics and Financial Trajectory for Naltrexone Hydrochloride

Last updated: July 28, 2025

Introduction

Naltrexone hydrochloride, a long-established opioid receptor antagonist approved by the FDA in 1984, primarily functions as an aid in alcohol and opioid dependence treatment. Its therapeutic profile and patent landscape have significantly influenced its market dynamics over recent decades. This article evaluates the evolving market environment, competitive forces, regulatory influences, and financial outlook for naltrexone hydrochloride, considering current trends and future opportunities.

Market Overview

Historical Context and Pharmacological Profile

Naltrexone hydrochloride is widely used to prevent relapse in opioid use disorder (OUD) and to reduce alcohol dependence. Its mechanism involves competitive inhibition of opioid receptors, diminishing the euphoric effects of opioids and alcohol. The drug’s well-documented safety profile and availability as a generic have supported broad clinical adoption.

Current Market Size and Segmentation

The global naltrexone market is part of the larger addiction treatment sector, which was valued at approximately USD 4.5 billion in 2022 (reports from Grand View Research). Naltrexone's market share within this sector is projected to grow modestly, guided by rising awareness of addiction treatments and expanding healthcare coverage. Segment-wise, the market includes:

• Prescription formulations: oral tablets, injectable depot formulations.
• Indication-specific sales: predominantly for opioid and alcohol dependence, with emerging off-label uses.

Market Drivers

Increasing Prevalence of Substance Use Disorders

The World Health Organization estimates over 280 million individuals with alcohol use disorders globally, compounded by rising opioid misuse. Governments and health organizations are prioritizing addiction treatment programs, which directly bolster demand for medications like naltrexone.

Advancements in Formulation and Delivery Systems

The development of long-acting injectable formulations, such as Vivitrol (by Alkermes), provides improved compliance and convenience, expanding market appeal. These innovations are particularly attractive in managing chronic conditions where adherence is critical.

Regulatory and Policy Support

Government initiatives aimed at opioid epidemic mitigation — including expanded Medicaid coverage and federal funding — facilitate access to addiction therapies, including naltrexone. Additionally, regulatory approvals extending indications or simplifying guidelines influence market access.

Growing Evidence Base and Off-label Uses

Emerging research suggests potential benefits of naltrexone for other indications, such as impulse control disorders and certain behavioral addictions, fostering interest and generating new revenue streams.

Market Challenges

Generic Competition and Pricing Pressures

Since its patent expired in the late 1990s, multiple generic manufacturers have entered the market, leading to significant price erosion and compressed profit margins. The low-cost nature of generics limits revenue potential, especially in heavily penetrated markets.

Limited Awareness and Stigma

Despite evidence supporting efficacy, stigma associated with addiction medications and limited prescriber awareness hinder optimal utilization. This results in underdiagnosis and undertreatment in certain populations.

Regulatory and Reimbursement Barriers

Variability across regions regarding approval for specific formulations or indications, and inconsistent reimbursement policies, can impede market expansion.

Future Financial Trajectory

Growth Projections

Forecasts suggest a compound annual growth rate (CAGR) of approximately 4-6% for the global naltrexone market over the next five years (according to Persistence Market Research). This growth is driven by increased adoption of long-acting formulations and expanding indications.

Impact of Innovation and Novel Delivery Systems

Innovative delivery mechanisms, such as implantable devices or combination therapies with behavioral interventions, could result in revenue uplifts. Notably, patent protections or orphan drug designations for specific formulations may create short-term pricing advantages.

Regional Market Dynamics

North America dominates the market, supported by established healthcare infrastructure, regulatory approval of injectables, and high awareness levels. Emerging markets in Asia-Pacific, Africa, and Latin America present growth opportunities, contingent on healthcare infrastructure improvements and policy reforms.

Potential Disruptors

The emergence of new pharmaceutical agents, such as buprenorphine or extended-release naltrexone alternatives, may impact market share dynamics. Additionally, the development of digital health interventions for addiction could complement or compete with traditional medication-based therapies.

Regulatory Landscape and Patent Considerations

While extended-release naltrexone formulations hold patent protections, many are nearing expiration, further intensifying generic competition. Manufacturers investing in formulation patents or combination therapies may mitigate revenue erosion and secure market exclusivity temporarily.

Conclusion

The financial trajectory of naltrexone hydrochloride remains cautiously optimistic, characterized by steady growth driven by increasing demand for addiction treatment, technological innovations, and expanding indications. However, market saturation, pricing pressures, and regulatory complexities necessitate strategic positioning for pharmaceutical companies aiming to capitalize on its market potential.

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Key Takeaways

1. Market Growth is Moderate but Sustainable: The global naltrexone market is expected to grow modestly at 4-6% CAGR over the next five years, fueled by rising addiction prevalence and formulation innovations.

2. Generic Competition Remains a Primary Challenge: Patent expirations and low-cost generics exert pressure on pricing and profitability, demanding strategic differentiation via formulations or niche indications.

3. Innovations and Extended Indications Offer Opportunities: Long-acting injectable formulations, combination therapies, and emerging off-label uses could foster revenue growth and market expansion.

4. Regulatory and Reimbursement Policies Will Significantly Influence Market Dynamics: Variability across regions requires tailored strategies, especially in emerging markets where structural healthcare reforms are ongoing.

5. Market Expansion Depends on Addressing Underlying Barriers: Increasing prescriber awareness, tackling stigma, and improving access are vital steps for unlocking the full market potential.

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FAQs

1. What are the key factors influencing naltrexone hydrochloride's market growth?
Market growth is primarily driven by rising addiction rates, innovation in drug formulations, and expanding indications. Conversely, generic competition, pricing pressures, and regulatory hurdles serve as dampening factors.

2. How does patent expiration impact naltrexone market revenue?
Patent expirations lead to a surge in generic entries, significantly reducing revenue margins for branded formulations and intensifying price competition.

3. Are there new formulations of naltrexone that could disrupt current market dynamics?
Yes. Long-acting injectable formulations like Vivitrol offer improved compliance and have been approved for multiple indications, providing competitive advantages and potential revenue growth.

4. What role do regulatory policies play in shaping the naltrexone market?
Regulatory approvals, reimbursement policies, and regional restrictions directly influence market access, adoption rates, and revenue potential, especially concerning novel delivery systems.

5. What future opportunities exist beyond traditional addiction treatments?
Emerging off-label uses, digital health integrations, and combination therapies with behavioral interventions are potential avenues for expanding naltrexone’s utility and market footprint.

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Sources

1. Grand View Research, "Addiction Treatment Market Size & Trends," 2022.
2. Persistence Market Research, "Global Naltrexone Market Forecast," 2023.
3. U.S. Food and Drug Administration, "Naltrexone Hydrochloride Approvals and Indications," 2022.
4. World Health Organization, "Global Status Report on Alcohol and Health," 2021.