CONTRAVE Drug Patent Profile

Which patents cover Contrave, and what generic alternatives are available?

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
Mayo Clinic	PHASE4
University of Toronto	PHASE4
The Royal's Institute of Mental Health Research	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	101588795
Peru	20161034
South Korea	20210012056
Japan	2021080274	過体重および肥満を治療する方法 (METHODS OF TREATING OVERWEIGHT AND OBESITY)
South Korea	20220042241	과체중 및 비만의 치료 방법 (METHODS OF TREATING OVERWEIGHT AND OBESITY)
Japan	2018158945	過体重および肥満を治療する方法 (METHODS OF TREATING OVERWEIGHT AND OBESITY)

Supplementary Protection Certificates for CONTRAVE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	349 22-2017	Slovakia		PRODUCT NAME: KOMBINACIA NALTREXONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM A BUPROPIONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456	657	Finland
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
0656775	CR 2000 00018	Denmark		PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
0656775	28/2000	Austria		PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CONTRAVE

Last updated: July 27, 2025

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Introduction

Contrave (naltrexone HCl/bupropion HCl extended-release) represents a key therapeutic agent in the landscape of obesity and weight management pharmacotherapy. Launched in 2014 by Orexigen Therapeutics, Inc., and subsequently marketed by commercial partners such as Takeda Pharmaceuticals, CONTRAVE addresses the chronic need for effective obesity medications amid rising global prevalence. Understanding its market dynamics and financial trajectory requires an analysis of regulatory landscapes, competitive positioning, clinical efficacy, and emerging socioeconomic trends. This comprehensive review explores these components, offering business professionals a strategic perspective on CONTRAVE’s current and future market outlook.

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Market Landscape and Drivers

Global Obesity Epidemic

The persistent rise in obesity globally acts as the primary driver of demand for pharmacological weight-loss solutions. The World Health Organization (WHO) estimates that more than 650 million adults were obese in 2016, with projections indicating an increasing trend annually [1]. Obesity correlates with comorbidities such as type 2 diabetes, cardiovascular diseases, and hypertension, amplifying the need for effective management options like CONTRAVE.

Regulatory Environment and Approvals

Contrave’s market penetration hinges significantly on regulatory approvals. In the United States, the FDA approved CONTRAVE in 2014, considering it safe for use alongside lifestyle interventions. Regulatory agencies in other regions, including Europe and Asia, are progressively evaluating its inclusion in treatment guidelines. Regulatory challenges, such as contraindications with certain psychiatric or cardiovascular conditions, shape its commercial reach.

Market Penetration and Physician Acceptance

Physician prescribing behaviors largely influence CONTRAVE’s sales trajectory. Despite FDA approval, uptake remains moderated by concerns regarding neuropsychiatric adverse effects and its safety profile compared to alternative treatments, including surgical interventions and newer pharmacotherapies. The drug competes with other anti-obesity agents like liraglutide (Saxenda), phentermine-topiramate, and surgical options, establishing a competitive environment that influences its market share trajectory.

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Competitive Positioning and Market Competition

Product Differentiation and Clinical Efficacy

Contrave’s mechanism combines naltrexone’s regulation of reward pathways with bupropion’s neurochemical modulation of appetite. Clinical trials demonstrate modest weight loss, generally averaging 5-10% of body weight over 56 weeks, with a safety profile that requires monitoring for neuropsychiatric and cardiovascular adverse events [2].

Compared to newer agents like semaglutide (Wegovy), which demonstrate weight reductions of up to 15%, CONTRAVE’s relative efficacy influences its adoption. Nonetheless, CONTRAVE offers advantages such as oral administration and a less complex safety profile.

Pricing and Reimbursement Strategies

Pricing strategies are pivotal to market success. CONTRAVE’s cost remains competitive against high-cost biologics, factoring into reimbursement decisions by insurers and healthcare systems. In the U.S., insurance coverage for weight-loss drugs varies, impacting patient access and prescription volumes. Ongoing negotiations with payers and inclusion in formulary lists are cardinal for sustained financial performance.

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Financial Trajectory and Revenue Trends

Historical Revenue Performance

Following its 2014 launch, CONTRAVE experienced modest growth, with estimates suggesting annual sales hovering around $50-$60 million in the initial years [3]. Factors limiting revenue included slow uptake, safety concerns, and limited physician awareness.

Growth Drivers and Market Expansion

Potential growth avenues entail geographic expansion into emerging markets where obesity rates are surging. Additionally, complementary strategies involve positioning CONTRAVE within comprehensive weight management programs, integrating behavioral and lifestyle interventions.

Impact of New Competitors and Pipeline Developments

The advent of more efficacious drugs with higher weight loss potential, particularly GLP-1 receptor agonists like semaglutide, presents a pressure point. These agents tend to dominate clinical decision-making, reducing CONTRAVE’s market share. However, its oral route and favorable safety profile remain advantageous in specific patient subsets.

Strategic Partnerships and Licensing

Partnerships with larger pharmaceutical corporations or licensing agreements can bolster CONTRAVE’s portfolio. For example, collaborations with payers or health authorities for broader access and patient adherence can improve sales trajectories.

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Market Risks and Opportunities

Risks

• Safety profile concerns: Neuropsychiatric adverse effects pose regulatory and market risks.
• Competitive landscape: Incorporation of potent biologics that demonstrate superior efficacy.
• Reimbursement hurdles: Variable insurance coverage and high co-pays limit access.
• Regulatory constraints: Post-marketing surveillance may prompt restrictions or label updates.

Opportunities

• Market expansion: Targeting unmet needs in outpatient, post-surgical, or pharmacologically naïve populations.
• Refined patient selection: Identifying subgroups responsive to CONTRAVE’s unique mechanism.
• Treating comorbidities: Positioning as part of therapeutic regimens for obesity-related conditions.
• Digital health integration: Enhancing adherence through mobile health applications.

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Future Perspectives

Projected trajectories for CONTRAVE’s financial performance depend on multiple factors. Market analysts forecast modest growth, with estimates suggesting a compounded annual growth rate (CAGR) of 2-4% in the obesity pharmacotherapy segment over the next five years [4]. This is predicated on increased awareness, initiatives to improve access, and potential regulatory label expansions. The evolution of the obesity treatment landscape, especially with innovations in injectable and oral medications, will influence CONTRAVE’s positioning.

Orexigen’s acquisition strategy, licensing deals, and clinical pipeline developments will also shape the asset’s valuation. The drug’s future appears resilient but constrained by the rapid advent of higher-efficacy therapies. Nonetheless, CONTRAVE’s established market presence, oral administration route, and reputation as a safety-conscious option position it as a complementary therapy within a broader obesity management paradigm.

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Key Takeaways

• Growing demand for obesity treatments driven by the global obesity epidemic creates ongoing market opportunities for CONTRAVE.
• Market penetration remains moderate due to safety concerns, competition from newer agents, and variability in reimbursement policies.
• Clinical efficacy of CONTRAVE is modest compared to emerging biologics, influencing physician prescribing behaviors.
• Financial performance anticipates slow but steady growth, with revenue stability depending on strategic expansion, partnerships, and improved coverage.
• Future success hinges on innovation, regulatory support, and positioning within comprehensive weight management strategies.

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FAQs

Q1: How does CONTRAVE compare to other obesity medications in terms of efficacy?
A1: CONTRAVE typically results in a 5-10% weight reduction over a year, which is moderate compared to newer agents like semaglutide, achieving up to 15% weight loss. Its efficacy is adequate for some patient populations but less impressive than biologics.

Q2: What are the primary safety concerns associated with CONTRAVE?
A2: Neuropsychiatric effects such as depression and suicidal ideation, as well as cardiovascular risks, particularly in patients with existing comorbidities, necessitate careful patient selection and monitoring.

Q3: What strategies could enhance CONTRAVE’s market share?
A3: Enhancing physician awareness, expanding access via insurance coverage, integrating digital adherence tools, and exploring combination therapies could bolster market presence.

Q4: Are there regulatory pathways that could expand CONTRAVE’s use?
A4: Label expansion to include broader patient populations or indications, based on ongoing clinical data, could improve prescribing and sales.

Q5: How does the geographic scope influence CONTRAVE’s financial trajectory?
A5: Limited international registration currently restricts its reach; navigating regulatory pathways in emerging markets could unlock new revenue streams.

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References

[1] World Health Organization. Obesity and Overweight. 2020.
[2] Apovian CM, et al. "Efficacy and Safety of Naltrexone-Bupropion in Obese and Overweight Patients." Obesity Reviews, 2014.
[3] MarketWatch. "Contrave Sales Figures and Market Analysis." 2022.
[4] GlobalData. "Obesity Pharmacotherapy Market Forecast," 2022.

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This analysis provides a data-driven, business-focused perspective on CONTRAVE, integrating clinical, regulatory, and commercial insights essential for strategic decision-making.