CONTRAVE Drug Patent Profile

When do Contrave patents expire, and when can generic versions of Contrave launch?

Contrave is a drug marketed by Nalpropion and is included in one NDA. There are nineteen patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and sixty-two patent family members in forty-six countries.

The generic ingredient in CONTRAVE is bupropion hydrochloride; naltrexone hydrochloride. There are thirty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bupropion hydrochloride; naltrexone hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Contrave

There have been two 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.

Indicators of Generic Entry

Summary for CONTRAVE

International Patents:	262
US Patents:	19
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	24
Patent Applications:	104
Drug Prices:	Drug price information for CONTRAVE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CONTRAVE
What excipients (inactive ingredients) are in CONTRAVE?	CONTRAVE excipients list
DailyMed Link:	CONTRAVE at DailyMed

See drug prices for CONTRAVE

Recent Clinical Trials for CONTRAVE

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

Sponsor	Phase
University of Toronto	PHASE4
Mayo Clinic	PHASE4
The Royal Ottawa Mental Health Centre	PHASE4

See all CONTRAVE clinical trials

Pharmacology for CONTRAVE

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

Paragraph IV (Patent) Challenges for CONTRAVE

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 CONTRAVE

CONTRAVE is protected by nineteen US patents.

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
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes			Y
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes

Expired US Patents for CONTRAVE

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
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014

International Patents for CONTRAVE

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

Country	Patent Number	Title	Estimated Expiration
China	114404419
Japan	2023086769	過体重および肥満を治療する方法 (METHODS OF TREATING OVERWEIGHT AND OBESITY)
Ecuador	SP15000223	MÉTODOS PARA ELT RATAMIENTO DEL SOBREPESO Y DE LA OBESIDAD
Chile	2007003246	METODO PARA INFLUIR EN LA PERDIDA DE PESO, SUPRIMIR EL APETITO Y/O TRATAR UNA ENFERMEDAD RELACIONADA CON LA OBESIDAD QUE COMPRENDE ADMINISTRAR UNA PRIMERA DOSIS DE UN PRIMER Y SEGUNDO FARMACO, ADMINISTRAR UNA SEGUNDA DOSIS QUE COMPRENDE DICHO PRIMER
Israel	248319	שיטות לאספקת טיפול לירידה במשקל לחולים עם דיכאון עמוק (Methods of providing weight loss therapy in patients with major depression)
China	101588795

Supplementary Protection Certificates for CONTRAVE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	122017000109	Germany		PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 20150326
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	CA 2017 00062	Denmark		PRODUCT NAME: NALTREXON ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NALTREXONHYDROCHLORID, OG BUPROPION ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BUPROPIONHYDROCHLORID; 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
0656775	CR 2000 00018	Denmark		PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201

Market Dynamics and Financial Trajectory for Contrave

Last updated: December 25, 2025

Executive Summary

Contrave (naltrexone/bupropion) is a prescription medication approved for weight management, targeting obesity and overweight individuals with comorbidities. With rising global obesity rates and increased awareness of metabolic health, Contrave’s market positioning presents substantial growth opportunities. However, competitive pressures from newer therapies, regulatory challenges, and shifting healthcare policies influence its dynamics. This analysis provides a comprehensive overview of Contrave’s market environment, financial trajectory, key drivers, and future outlook.

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What are the fundamentals of Contrave?

Drug Name	Contrave	Generic Name	Naltrexone/Bupropion SR	Approval Date (FDA)	2014
Indications	Obesity, weight management
Dosage Forms	Extended-release oral tablets
Mechanism of Action	Combines appetite suppression (bupropion) with reward pathway modulation (naltrexone)

Source: FDA prescribing information [1]

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Market Landscape for Contrave

Global Obesity and Weight Management Market Overview

Region	Market Size (USD Billion, 2022)	Projected CAGR (2023-2028)	Key Drivers
North America	4.5	7.0%	High obesity prevalence, strong healthcare infrastructure
Europe	2.2	6.0%	Growing awareness, aging population
Asia-Pacific	1.8	8.5%	Expanding middle class, urbanization
Rest of World	0.9	7.2%	Increasing obesity awareness

Source: Market Research Future [2], GlobalData [3]

Competitive Landscape

Major Players	Products	Market Share (Estimate)	Unique Selling Proposition
Novo Nordisk	Wegovy (semaglutide), Saxenda	~40%	Efficacy in weight loss
Eli Lilly	Tirzepatide	Emerging	Strong weight reduction data
Obese Medications (Off-label or other)	Qsymia, Belviq (market withdrawn)	Remaining	Established protocols, insurance coverage
Contrave	Naltrexone/Bupropion SR	Estimated 12-15%	Oral administration, dual mechanism

Note: Exact market share data is proprietary, derived from industry estimates [4]

Key Market Trends

• Increasing Obesity Prevalence: 650 million adults globally are obese (WHO, 2022).
• Shift Toward Pharmacotherapy: Rising preference for minimally invasive weight management options.
• Insurance Coverage Variance: Coverage policies impact prescription rates.
• Emergence of Injectable GLP-1 Receptor Agonists: Agents like semaglutide demonstrate superior efficacy but at higher costs.
• Regulatory Adjustments: FDA requests for post-marketing studies influence product positioning.

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What Are the Financial Trajectories and Revenue Drivers?

Revenue Streams

Source	Description	Estimated Contribution (2022)
Prescription Sales	Primary revenue source	~85%
Reimbursement & Insurance	Affects volume	Variable
Market Expansion	New regions, indications	Increasing
Direct-to-Consumer (DTC) Marketing	Awareness campaigns	Limited, dependent on regulation

Note: Exact financial data confidential; estimates based on industry reports and company disclosures.

Historical Sales Performance

Year	Global Sales (USD Million)	Growth Rate	Notes
2018	200	—	Launch phase; growing awareness
2019	250	25%	Increased prescriber adoption
2020	270	8%	Impact of COVID-19, shift to telehealth
2021	300	11%	Recovery and market expansion
2022	330	10%	Stability amid competitive pressure

Source: IQVIA data (approximate estimates) [5]

Forecasted Financial Trajectory (2023-2028)

Year	Projected Sales (USD Million)	CAGR	Major Assumptions
2023	355	7.6%	Increased awareness, stable market share
2024	380	7.0%	Broader insurance coverage, wider prescriber base
2025	410	8.0%	New regional launches, expanded indications
2026	440	7.3%	Competitive landscape steadies
2027	470	6.8%	Market saturation risk remains
2028	500	6.4%	Potential impact of GLP-1 dominance

Note: Market projections depend on regulatory status, competitor performance, and healthcare policies.

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What Are the Key Factors Influencing Market Dynamics?

Factor	Impact	Details
Obesity Prevalence	High	Drives demand, especially in North America and Asia
Competitive Products	Moderate	Semaglutide (Wegovy) shows superior efficacy, impacting Contrave’s share
Regulatory Environment	Critical	FDA and EMA guidelines influence approvals, post-marketing commitments
Reimbursement Policies	Variable	Access impacted by insurance coverage; affects prescribing patterns
Clinical Evidence	Pivotal	Demonstrations of efficacy/safety determine clinician confidence
Lifestyle & Behavioral Factors	Influential	Societal shifts favor pharmacotherapy alongside lifestyle modifications
COVID-19 Pandemic	Temporary	Disrupts prescription volume, shifts to telemedicine

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How Does Contrave Compare with Competitors?

Parameter	Contrave	Wegovy (semaglutide)	Qsymia	Saxenda
Mechanism	Central appetite suppression	GLP-1 receptor agonist	Sympathomimetic, anticonvulsant	GLP-1 analogue
Efficacy	Moderate	High (up to 15% weight loss)	Moderate	Moderate
Administration	Oral	Subcutaneous injection	Oral	Subcutaneous injection
Cost (Approx.)	$300-400/month	>$1,300/month	$200-350/month	>$1,200/month
Regulatory Status	Approved	Approved	Approved	Approved
Market Penetration	Moderate	Fast-growing	Established	Stable

Source: Company filings, peer-reviewed studies [1][4]

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What Are the Future Opportunities and Challenges?

Opportunities

• Indication Expansion: Use in adolescents, bariatric populations, or metabolic syndrome adjuncts.
• Formulation Improvements: Developing long-acting or combination strategies to improve compliance.
• Market Penetration: Greater presence in emerging markets especially via partnerships.
• Policy Incentives: Favorable reimbursement in developed nations as obesity becomes a healthcare priority.

Challenges

• Competitive Pressure: Dominance of GLP-1 receptor agonists like semaglutide.
• Regulatory Concerns: Post-marketing safety commitments.
• Pricing Pressures: Payers demanding cost-effective therapies.
• Patient Adherence: Behavioral factors impacting long-term usability.

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Deep Dive: Regulatory and Policy Considerations

Region	Regulatory Status	Reimbursement Policies	Key Policies/Evolutions
United States	FDA approved (2014)	Varies; coverage depends on insurer	New guidelines favor combination therapies
European Union	CE Mark	Coverage varies	EMA emphasizes real-world evidence
Asia-Pacific	Approvals in select countries	Developing reimbursement frameworks	Growing regulatory stringency

Source: FDA, EMA, national health agencies [1][2]

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Conclusion: Navigating Contrave's Market Future

Contrave occupies a niche in the weight management landscape with a moderate but steady revenue trajectory. The drug benefits from an established safety profile and the convenience of oral administration, appealing in markets cautious about injections. However, the ascent of GLP-1 receptor agonists with superior efficacy presents significant competition. Strategic positioning through indications expansion, differentiated formulations, and targeted market entry in high-growth regions remains vital.

Manufacturers and stakeholders should closely monitor geopolitical policies, advancements in pharmacotherapy, and evolving reimbursement landscapes to optimize Contrave’s market share and financial performance.

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Key Takeaways

• The global obesity market is expanding at approximately 7-8% CAGR, propelled by rising obesity prevalence.
• Contrave's sales are projected to stabilize around USD 500 million by 2028, contingent on competitive dynamics.
• Competition from injectable GLP-1 therapies like Wegovy significantly challenges Contrave’s market position.
• Regulatory and reimbursement policies significantly influence market access and profitability.
• Market expansion through indications, regional penetration, and formulation innovations presents growth opportunities.

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FAQs

1. How does Contrave differ from other obesity drugs?

Contrave combines naltrexone and bupropion, targeting appetite suppression and reward pathways, offering an oral, dual-mechanism option. In contrast, GLP-1 receptor agonists like semaglutide (Wegovy) generally demonstrate higher efficacy but require injections.

2. What regulatory hurdles does Contrave face?

While FDA approved in 2014, ongoing post-marketing studies and safety assessments are common. Future approvals or restrictions depend on emerging safety profiles and comparative efficacy data.

3. What factors influence insurance coverage for Contrave?

Insurance decisions hinge on clinical efficacy, cost-effectiveness, and comparative advantages relative to newer agents. Variability exists, especially between private insurers and national health systems.

4. Which regions present the most growth opportunities for Contrave?

Emerging markets in Asia-Pacific and Latin America offer significant upside due to rising obesity rates, increasing healthcare infrastructure, and evolving reimbursement policies.

5. How might future developments affect Contrave's market?

Advances in pharmacotherapy, policy shifts favoring innovative treatments, and potential new indications could either bolster or diminish Contrave’s market share, depending on competitive positioning and regulatory context.

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References

[1] FDA. Contrave (naltrexone HCl and bupropion HCl extended-release tablets). Prescribing Information, 2014.
[2] Market Research Future. Weight Management Market Analysis, 2023.
[3] GlobalData. Obesity Market Outlook, 2023.
[4] IQVIA. Global Pharmaceutical Market Trends, 2022.
[5] Company Financial Disclosures, 2022.