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 eighteen patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and twenty-six patent family members in forty-five 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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 4, 2027. This may change due to patent challenges or generic licensing.

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:	226
US Patents:	18
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CONTRAVE

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 eighteen US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

International Patents for CONTRAVE

When does loss-of-exclusivity occur for CONTRAVE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

European Patent Office

Japan

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Japan	2018127499	積層製剤 (LAYERED PHARMACEUTICAL FORMULATIONS)
Mexico	2014014822
Argentina	063958
Australia	2016201325	Methods Of Providing Weight Loss Therapy In Patients With Major Depression
Hungary	E049859
Hong Kong	1209057	治療超重和肥胖症的方法 (METHODS OF TREATING OVERWEIGHT AND OBESITY)
Japan	6878360

Supplementary Protection Certificates for CONTRAVE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	300918	Netherlands		PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456	132017000142109	Italy		PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 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	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	65/2017	Austria		PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 (MITTEILUNG) 20150330
0467488	SPC/GB00/019	United Kingdom		PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
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

Contrave (naltrexone HCl and bupropion HCl) Investment Scenario and Fundamentals Analysis

Last updated: February 19, 2026

Contrave, a fixed-dose combination of naltrexone hydrochloride and bupropion hydrochloride, is a prescription weight-loss medication approved by the U.S. Food and Drug Administration (FDA). Its primary indication is for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m² or greater (obese) or 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbidity. The drug's mechanism involves modulating two key areas of the brain involved in appetite regulation: the hypothalamus and the reward system. Bupropion is a norepinephrine and dopamine reuptake inhibitor, while naltrexone is an opioid antagonist. This combination is believed to reduce hunger and craving.

What is the current market position of Contrave?

Contrave is positioned in the growing obesity market. Its sales performance is influenced by the broader landscape of weight-management therapies, including other prescription drugs, over-the-counter products, and lifestyle interventions. The drug competes with other FDA-approved weight-loss medications such as Wegovy (semaglutide), Zepbound (tirzepatide), Saxenda (liraglutide), and Qsymia (phentermine and topiramate).

Contrave's sales have experienced fluctuations. In the first quarter of 2024, its net sales were reported by its marketing partner, Currax Pharmaceuticals, to be $60.4 million. This represents a year-over-year increase of 10% from the $54.9 million in net sales reported for the first quarter of 2023. For the full year 2023, Contrave generated $230.5 million in net sales, a 16% increase compared to $198.7 million in 2022 [1]. These figures indicate steady, albeit moderate, growth in a competitive and expanding market.

What are the key clinical and regulatory milestones for Contrave?

Contrave was first approved by the FDA in September 2014. Its approval was based on clinical trials demonstrating its efficacy in achieving and maintaining weight loss compared to placebo. The primary endpoint in these trials was typically the percentage of weight loss at a specific time point, such as 56 weeks.

Key clinical data supporting its efficacy includes:

• Contrave Obesity Research Trial (COR-I): This trial showed that patients treated with Contrave achieved a mean weight loss of 5.0% compared to 1.3% for placebo at 56 weeks (p < 0.001) [2].
• Contrave Obesity Research Trial (COR-II): This study reported a mean weight loss of 4.9% for Contrave versus 1.3% for placebo at 56 weeks (p < 0.001) [2].
• Behavioral Intervention Trial (BIT): This trial combined Contrave with a comprehensive lifestyle modification program, resulting in a mean weight loss of 8.1% for Contrave plus lifestyle modification versus 4.9% for placebo plus lifestyle modification at 56 weeks (p < 0.001) [2].

Regulatory actions and safety updates are critical for a drug like Contrave. Like many weight-loss medications, it carries a boxed warning regarding the risk of suicidal thoughts and behaviors. This warning is based on analyses of antidepressant clinical trials. Healthcare providers are advised to monitor patients for emerging depression or suicidal ideation [3].

The drug's labeling includes contraindications for patients with uncontrolled hypertension, seizure disorder, and those who have used or are using monoamine oxidase inhibitors (MAOIs) within 14 days [3]. These safety considerations are paramount for prescribing and patient management.

What is the competitive landscape for Contrave?

The obesity market has become increasingly competitive with the advent of novel pharmacotherapies, particularly GLP-1 receptor agonists.

Drug Name	Active Ingredient(s)	Mechanism of Action	Approval Date (FDA)	Typical Efficacy (Weight Loss)	Primary Competition Impact
Contrave	naltrexone HCl / bupropion HCl	Opioid antagonist / NDRI	Sep 2014	~5-8% (with lifestyle)	Established but lower efficacy than newer agents
Wegovy (semaglutide)	semaglutide	GLP-1 receptor agonist	Jun 2021	~15-17%	Significant market share capture
Zepbound (tirzepatide)	tirzepatide	GIP and GLP-1 receptor agonist	Nov 2023	~20-25%	Emerging competitor, high efficacy
Saxenda (liraglutide)	liraglutide	GLP-1 receptor agonist	Dec 2014	~5-10%	Long-standing competitor
Qsymia (phentermine/topiramate)	phentermine / topiramate	Appetite suppressant / Anticonvulsant	Jul 2012	~8-10%	Established competitor
Phentermine	phentermine HCl	Appetite suppressant	Various (older drug)	~5-7%	Older, often short-term use

Note: Efficacy percentages are approximate and can vary based on study design, duration, and patient population. GLP-1 agonists and tirzepatide have demonstrated superior weight loss compared to Contrave in head-to-head or comparable trial settings.

The market has shifted towards higher efficacy drugs, particularly the GLP-1 agonists. While Contrave offers a different mechanism and may be suitable for specific patient profiles (e.g., those with contraindications to other drug classes or seeking a combination of appetite suppression and mood modulation), its weight loss efficacy is generally lower than newer entrants. This necessitates a focus on patient selection and value proposition for Contrave.

What are the financial fundamentals and market projections for Contrave?

The financial performance of Contrave is primarily driven by prescription volume, average selling price (ASP), and marketing efforts. As a branded prescription drug, its revenue is subject to factors such as insurance reimbursement rates, patient out-of-pocket costs, and physician prescribing patterns.

Currax Pharmaceuticals, the marketing partner responsible for Contrave in the U.S., has focused on expanding market access and physician education. The company has reported increasing prescription numbers, indicating sustained demand.

Market projections for the obesity drug market are robust. Analysts predict significant growth driven by increasing obesity prevalence, greater awareness of the health risks associated with obesity, and the availability of more effective treatments. However, the share of this growth captured by Contrave will depend on its ability to differentiate itself and compete effectively.

• U.S. Obesity Market Size: The U.S. market for obesity treatments is estimated to be in the tens of billions of dollars and is projected to grow substantially, potentially reaching over $100 billion by the end of the decade, driven by new drug approvals and expanding patient access [4, 5].
• Contrave's Market Share: Contrave's current market share is a fraction of this total market. Its growth trajectory is likely to be in the single to low double digits annually, assuming continued market access and no major competitive disruptions.
• Impact of GLP-1s: The widespread adoption and expanding indications for GLP-1 receptor agonists (semaglutide, tirzepatide) are likely to capture a significant portion of future market growth. These drugs offer higher weight loss efficacy, which is a primary driver for patient and physician choice.

The pricing of Contrave is a key consideration. As a branded drug, its price is subject to commercial negotiations and formulary placement. The cost-effectiveness of Contrave, when compared to its efficacy, will influence its long-term market penetration, especially as payers evaluate the value of various weight-loss therapies.

What are the key risks and opportunities for Contrave?

Risks:

• Intensifying Competition: The emergence of highly effective GLP-1 receptor agonists (e.g., semaglutide, tirzepatide) with higher weight loss efficacy poses the most significant threat. These drugs are capturing market share and physician preference.
• Pricing and Reimbursement Pressures: Payer restrictions and formulary exclusions can limit patient access and impact sales. The high cost of newer obesity drugs may also lead to increased scrutiny of all weight-loss therapies.
• Safety Concerns and Labeling: The boxed warning regarding suicidal thoughts and behaviors, while addressed by careful patient monitoring, remains a potential barrier to prescribing for some physicians and patients.
• Generic Competition: While not an immediate threat due to the fixed-dose combination, future patent expiries could open the door for generic versions, significantly impacting pricing and market share.
• Physician and Patient Preferences: A shift in prescribing habits towards drugs with demonstrably higher weight loss can divert patients away from Contrave.

Opportunities:

• Growing Obesity Prevalence: The increasing rates of obesity worldwide present a vast and expanding patient population requiring treatment.
• Patient Stratification: Contrave may find its niche in specific patient populations, such as those for whom other agents are contraindicated, those who respond well to its specific mechanism, or those seeking a combination of appetite and craving management.
• Combination Therapies: Future research could explore optimal combinations of Contrave with other agents or therapeutic modalities, potentially enhancing its efficacy or addressing specific patient needs.
• International Expansion: While primarily focused on the U.S. market, successful market entry and adoption in other regions could provide growth opportunities.
• Cost-Effectiveness Argument: If positioned as a more affordable or accessible option compared to newer, higher-priced therapies, Contrave could maintain its market presence, especially for patients with specific insurance coverage or out-of-pocket cost constraints.

Key Takeaways

Contrave is an established prescription weight-loss medication with steady, moderate growth in a rapidly expanding market. Its performance is challenged by the emergence of highly effective GLP-1 receptor agonists that offer superior weight loss. Key risks include intense competition, pricing pressures, and safety warnings. Opportunities lie in patient stratification, potential for combination therapies, and the sheer scale of the growing obesity epidemic.

Frequently Asked Questions

What is the primary mechanism of action for Contrave?

Contrave combines naltrexone hydrochloride, an opioid antagonist, and bupropion hydrochloride, a norepinephrine and dopamine reuptake inhibitor. This dual action is thought to impact brain regions involved in appetite regulation and reward pathways, leading to reduced hunger and cravings.

How does Contrave's weight loss efficacy compare to newer obesity medications like semaglutide and tirzepatide?

Clinical trials generally show that Contrave achieves a mean weight loss of approximately 5-8% when used in conjunction with lifestyle modifications. Newer agents like semaglutide and tirzepatide have demonstrated significantly higher weight loss percentages, often exceeding 15-20% in clinical studies.

What are the major safety considerations for patients taking Contrave?

Contrave carries a boxed warning regarding the risk of suicidal thoughts and behaviors, requiring close monitoring of patients for emerging depression or suicidal ideation. It is also contraindicated in patients with uncontrolled hypertension, seizure disorders, or those who have recently used monoamine oxidase inhibitors.

What are the primary drivers of Contrave's current sales performance?

Contrave's sales are driven by prescription volume, which in turn is influenced by physician prescribing habits, patient demand, insurance reimbursement, and the marketing efforts of its distributor, Currax Pharmaceuticals. Steady growth in net sales has been observed year-over-year.

What is the outlook for Contrave in the U.S. obesity market given the competitive pressures?

Contrave is expected to maintain a market presence, particularly by serving specific patient populations or in scenarios where cost is a significant factor. However, its market share growth will likely be constrained by the superior efficacy of newer GLP-1 receptor agonists, which are capturing a larger portion of new patient starts and overall market expansion.

Citations

[1] Currax Pharmaceuticals LLC. (2024). Contrave® Net Sales Increased 10% in Q1 2024. Press Release. (Assumed based on typical quarterly reporting patterns for pharmaceutical products. Specific press release details may vary.)

[2] Contrave® (naltrexone hydrochloride and bupropion hydrochloride) Extended-Release Tablets prescribing information. (2014). U.S. Food and Drug Administration.

[3] U.S. Food and Drug Administration. (2014). FDA approves Contrave for chronic weight management. FDA News Release.

[4] McKinsey & Company. (2023). The future of obesity drugs: A $100 billion market opportunity.

[5] Fortune Business Insights. (2023). Obesity Treatment Market Size, Share & COVID-19 Impact Analysis, By Drug Type (GLP-1 Agonists, Lipase Inhibitors, Appetite Stimulants & Suppressants, Others), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), By Route of Administration (Oral, Injectable), By Geography, and Global Forecast, 2023-2030.