Bupropion hydrochloride; naltrexone hydrochloride - Generic Drug Details

What are the generic sources for bupropion hydrochloride; naltrexone hydrochloride and what is the scope of patent protection?

Bupropion hydrochloride; naltrexone hydrochloride is the generic ingredient in one branded drug marketed by Nalpropion and is included in one NDA. There are nineteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bupropion hydrochloride; naltrexone hydrochloride has two hundred and sixty-two patent family members in forty-six countries.

One supplier is listed for this compound.

Summary for bupropion hydrochloride; naltrexone hydrochloride

International Patents:	262
US Patents:	19
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	56
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bupropion hydrochloride; naltrexone hydrochloride
DailyMed Link:	bupropion hydrochloride; naltrexone hydrochloride at DailyMed

Recent Clinical Trials for bupropion hydrochloride; naltrexone hydrochloride

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

Sponsor	Phase
Mayo Clinic	PHASE4
University of Toronto	PHASE4
Bausch Health Canada	PHASE4

See all bupropion hydrochloride; naltrexone hydrochloride clinical trials

Pharmacology for bupropion hydrochloride; naltrexone hydrochloride

Drug Class	Aminoketone Opioid Antagonist
Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors Opioid Antagonists
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

Anatomical Therapeutic Chemical (ATC) Classes for bupropion hydrochloride; naltrexone hydrochloride

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

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

Paragraph IV (Patent) Challenges for BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CONTRAVE	Extended-release Tablets	bupropion hydrochloride; naltrexone hydrochloride	8 mg/90 mg	200063	1	2015-03-12

US Patents and Regulatory Information for bupropion hydrochloride; naltrexone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes	10,828,294
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes	8,318,788
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes	11,324,741
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes	10,403,170

Expired US Patents for bupropion hydrochloride; naltrexone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014	11,278,544
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014	8,815,889
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014	7,462,626
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014	7,375,111

International Patents for bupropion hydrochloride; naltrexone hydrochloride

Country	Patent Number	Title	Estimated Expiration
Mexico	2019008217	COMPOSICIONES DE LIBERACION SOSTENIDA DE NALTREXONA Y BUPROPION PARA USARSE EN EL TRATAMIENTO DE SOBREPESO Y OBESIDAD. (METHODS OF TREATING OVERWEIGHT AND OBESITY.)
Japan	2014005310	SUSTAINED RELEASE FORMULATION OF NALTREXONE
South Korea	101841442
European Patent Office	2316456	Compositions comprenant un antagoniste des opioides et bupropion pour influencer la perte de poids (Compositions for affecting weight loss comprising an opioid antagonist and bupropion)

Supplementary Protection Certificates for bupropion hydrochloride; naltrexone hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	C20170044 00252	Estonia		PRODUCT NAME: NALTREKSOON/BUPROPIOON;REG NO/DATE: EU/1/14/988 30.03.2015
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	C201730057	Spain		PRODUCT NAME: NALTREXONA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA, EN PARTICULAR CLORHIDRATO DE NALTREXONA, Y BUPROPION O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR CLORHIDRATO DE BUPROPION.; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
2316456	2017C/064	Belgium		PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330

Market Dynamics and Financial Trajectory for Bupropion Hydrochloride and Naltrexone Hydrochloride

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape for bupropion hydrochloride and naltrexone hydrochloride has experienced significant shifts driven by evolving market demands, regulatory updates, and the expanding adoption of combination therapies. As a combination used predominantly in weight management and smoking cessation, these drugs' commercial prospects are intertwined with broader healthcare trends, including rising obesity rates, increasing substance dependence treatment, and a preference for oral prescription solutions. This analysis explores the current market drivers, competitive dynamics, regulatory environment, and financial trajectory for these pharmaceuticals.

Market Overview

Bupropion Hydrochloride (marketed as Wellbutrin, Zyban, and generics) is primarily prescribed for depression, smoking cessation, and off-label uses such as weight management. Naltrexone Hydrochloride (marketed as Revia, Vivitrol, and generics) functions mainly in opioid dependence and alcohol use disorder treatments.

The combination of these medications, particularly in branded formulations like Contrave (marketed jointly by Orexigen Therapeutics and Takeda), has carved a niche in obesity management, signaling a strategic diversification beyond their traditional indications. The North American market is the dominant revenue generator, with Europe and Asia witnessing growing adoption due to expanding mental health and addiction treatment paradigms.

Market Drivers

Rising Prevalence of Obesity and Substance Use Disorders

The global obesity epidemic is a principal driver, with the World Health Organization reporting over 650 million adults obese as of 2020, fueling demand for effective pharmacotherapies [1]. Contrave's approval by the FDA for weight management in obese or overweight adults has reinforced market legitimacy. Simultaneously, the opioid crisis underscores the need for effective medications for addiction treatment, bolstering naltrexone's market share.

Expanding Therapeutic Indications and Off-label Uses

While originally indicated for depression and alcohol dependence, clinicians increasingly prescribe these drugs off-label for weight loss, especially when combined with behavioral therapy. Such off-label usage expands the commercial footprint but also raises regulatory and reimbursement complexities.

Emerging Competition and Pharmacological Innovations

The market faces competition from newer agents like GLP-1 receptor agonists (e.g., semaglutide, liraglutide), which currently lead in weight loss efficacy [2]. Nevertheless, bupropion-naltrexone combination retains appeal due to oral administration, cost-effectiveness, and familiarity among clinicians.

Regulatory Landscape

Post-approval regulatory decisions have shaped the trajectory. The FDA approved Contrave in 2014, and subsequent label updates have included label expansions and safety warnings. Variability in regulatory acceptance, especially regarding off-label use and patent protections, significantly influences market dynamics.

Financial Trajectory and Market Forecast

Historical Financial Performance

The combined market for bupropion and naltrexone in combination therapy was valued at approximately USD 1.2 billion globally in 2022, with North America accounting for over 70% [3]. Growth in this segment has averaged around 8% annually over the past five years, driven by increased prescription volumes and new formulations.

Projection and Growth Outlook

Industry analysts project a compound annual growth rate (CAGR) of around 7% to 9% over the next five years, contingent on regulatory approvals, market penetration of the combination in obesity and addiction segments, and competitive dynamics. The anticipated expansion of telemedicine and digital health tools will further facilitate patient access, potentially accelerating adoption.

Increased competition is expected with the advent of novel pharmacologics, which may pressure pricing and margins. Nonetheless, patent expirations for some formulations and potential for new combination products (e.g., incorporating SGLT2 inhibitors or other metabolic agents) could rejuvenate growth avenues.

Impact of Patent Expirations and Generic Entry

The expiration of key patents in the early 2020s has led to a surge in generic formulations, resulting in significant price erosion. For instance, generic bupropion sales soared post-patent expiry, and similar trends are anticipated for naltrexone. While generics dilute revenue streams for original developers, they enable broader access and volume-based growth.

Reimbursement Trends

Reimbursement policies heavily influence market performance. Favorable coverage for obesity and addiction treatments supports higher prescription volume, while restrictive policies or high copayment burdens impede growth.

Market Challenges and Opportunities

Challenges:

• Competition from high-efficacy, injectable GLP-1 analogs.
• Safety concerns linked to neuropsychiatric adverse effects of bupropion.
• Regulatory scrutiny over off-label uses and label expansion attempts.
• Pricing pressures due to generic proliferation.

Opportunities:

• Development of combination formulations with improved safety profiles.
• Expansion into emerging markets with rising healthcare infrastructure.
• Incorporation into multimodal obesity and addiction treatment protocols.
• Strategic partnerships and licensing agreements to extend market reach.

Conclusion

The market for bupropion hydrochloride and naltrexone hydrochloride remains resilient amid competitive forces and patent expirations. While the current financial trajectory forecasts moderate growth driven by obesity and addiction treatment needs, ongoing innovations and economic considerations will shape its future. Stakeholders capable of navigating regulatory landscapes and leveraging market expansion opportunities will be poised for sustained value creation.

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Key Takeaways

• The combined pharmacotherapies for weight management and addiction maintain a steady growth trajectory, primarily supported by the rising burden of obesity and substance use disorders.
• Patent expirations have introduced price competition, but increased adoption and broader insurance coverage underpin continued revenue streams.
• Emerging competition from biologics and novel agents necessitates strategic innovation and diversification for sustained market relevance.
• Geographic expansion into emerging markets offers significant upside, provided regulatory and reimbursement hurdles are addressed.
• Continuous safety monitoring and regulatory compliance are essential for long-term market stability and financial performance.

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FAQs

1. What are the primary therapeutic indications for bupropion and naltrexone?
   Bupropion is mainly used for depression and smoking cessation, while naltrexone targets opioid, alcohol dependence, and in combination for weight management.

2. How has patent expiration affected the market for these drugs?
   Patent expirations have led to the entry of generic versions, reducing prices and squeezing margins for branded formulations, while increasing accessibility and volume sales.

3. What are the main competitive threats to bupropion-naltrexone combination therapy?
   Newer weight loss drugs like semaglutide, injectable GLP-1 receptor agonists, and other combination therapies present significant competition due to superior efficacy.

4. What regulatory factors influence the financial trajectory of these drugs?
   FDA approval status, label expansions, safety warnings, and reimbursement policies directly impact sales volume and market share.

5. What growth opportunities exist for these pharmaceuticals?
   Expanding into emerging markets, developing novel formulations, and integrating digital health tools for adherence can bolster future revenue streams.

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References

[1] WHO. (2020). Obesity and overweight. World Health Organization.
[2] Wilding, J. P., et al. (2021). Semaglutide for Weight Management in Adults with Overweight or Obesity. New England Journal of Medicine.
[3] MarketResearch.com. (2023). Global Weight Management Drugs Market Analysis.