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-eight 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:	228
US Patents:	18
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	24
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CONTRAVE

Constraining patent/regulatory exclusivity:

9,107,837

NDA:

200063

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 eighteen US patents.

This potential generic entry date is based on patent 9,107,837.

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	8,722,085
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes	8,088,786		Y
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes	11,139,056
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes	10,231,964

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	8,815,889
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	7,462,626
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014	7,375,111

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

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
Argentina	098631
Argentina	120476
Australia	2014360492
Brazil	112016012755

Supplementary Protection Certificates for CONTRAVE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0467488	SPC/GB00/019	United Kingdom		PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
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
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

CONTRAVE: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is CONTRAVE and its Mechanism of Action?

CONTRAVE is a prescription weight-loss medication approved by the U.S. Food and Drug Administration (FDA). Its active ingredients are naltrexone hydrochloride and bupropion hydrochloride [1]. Naltrexone is an opioid antagonist, and bupropion is an antidepressant and smoking cessation aid. The combination targets specific areas of the brain involved in appetite regulation and reward pathways [2]. Bupropion inhibits the reuptake of norepinephrine and dopamine, increasing their availability in the brain. Naltrexone blocks opioid receptors. The synergistic action of these two components is believed to reduce hunger and cravings by modulating the brain's reward system, particularly the melanocortin system [3].

What are the Approved Indications for CONTRAVE?

CONTRAVE is indicated as a long-term weight management medication for 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, such as hypertension, type 2 diabetes, or dyslipidemia [1]. It is intended to be used in conjunction with a reduced-calorie diet and increased physical activity.

What is the Clinical Efficacy of CONTRAVE?

Clinical trials have demonstrated CONTRAVE's efficacy in promoting weight loss. In a pooled analysis of two 56-week, randomized, double-blind, placebo-controlled trials involving over 3,000 participants, individuals treated with CONTRAVE achieved statistically significant greater mean weight loss compared to placebo [4].

• Diet-induced weight loss: Participants receiving CONTRAVE achieved an average weight loss of 5.0% of body weight, while the placebo group lost 1.3% [4].
• Percentage of responders: Approximately 33% of participants on CONTRAVE achieved ≥5% weight loss, compared to 16% on placebo. Furthermore, 14% of the CONTRAVE group achieved ≥10% weight loss, versus 4% on placebo [4].
• Comorbidity improvement: Studies have also shown improvements in cardiometabolic risk factors, including blood pressure, lipid profiles, and glycemic control, in individuals taking CONTRAVE alongside weight loss [5].

What is the Regulatory Status and Patent Landscape of CONTRAVE?

CONTRAVE was approved by the FDA on September 10, 2014 [6]. The drug is marketed by Currax Pharmaceuticals LLC.

The patent landscape for CONTRAVE is complex and involves patents covering the active ingredients, specific formulations, and methods of use. Key patents include:

• U.S. Patent No. 6,139,879: Covers the use of bupropion and naltrexone in combination for weight management. This patent was initially set to expire in 2020 but has seen various extensions and challenges [7].
• U.S. Patent No. 8,124,107: Related to specific controlled-release formulations of the combination therapy.
• U.S. Patent No. 8,841,315: Covers methods of treating obesity and related conditions using the combination.

The expiration of key patents can significantly impact market exclusivity and open the door for generic competition. Generic versions of naltrexone/bupropion are available, leading to increased market competition and potential price erosion for branded CONTRAVE.

What is the Market Size and Growth Trajectory of the Obesity Drug Market?

The global obesity drug market is a significant and growing segment within the pharmaceutical industry. Factors driving this growth include increasing prevalence of obesity worldwide, rising awareness of the health risks associated with obesity, and advancements in therapeutic development [8].

• Market Valuation: The global obesity drugs market was valued at approximately USD 2.6 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 8.5% from 2023 to 2030 [9].
• Market Drivers: Increasing healthcare expenditure, a growing number of obese and overweight individuals, and the development of novel therapeutic agents are key drivers [8].
• Market Challenges: High cost of treatment, potential side effects, and the need for lifestyle modifications can pose challenges to market penetration and patient adherence [10].

CONTRAVE operates within this broader market, facing competition from other prescription weight-loss medications and emerging therapies.

How Has CONTRAVE Performed Financially?

Financial performance data for CONTRAVE is often reported by its respective marketing companies. While specific standalone revenue figures for CONTRAVE can be difficult to isolate without direct company disclosures, its performance is influenced by prescription volume, pricing, and market access.

• Sales Trends: Following its launch, CONTRAVE experienced initial sales growth. However, the introduction of generic alternatives and the emergence of newer obesity medications, particularly GLP-1 receptor agonists, have likely impacted its market share and revenue trajectory.
• Competitive Landscape Impact: The pharmaceutical market for obesity treatments is highly competitive. The success of newer drugs like semaglutide (Wegovy) and tirzepatide (Zepbound) has shifted market dynamics, potentially drawing patient and prescriber focus away from older medications.
• Genericization: The availability of generic naltrexone/bupropion products has led to price competition, affecting the profitability of branded CONTRAVE.

Specific financial figures from Currax Pharmaceuticals LLC are not publicly detailed in a way that isolates CONTRAVE's revenue generation. However, as a product within the obesity therapeutic class, its performance is benchmarked against the broader market trends and competitive pressures within this segment.

What are the Key Competitors to CONTRAVE?

CONTRAVE competes with a range of prescription medications for weight management. The competitive landscape has evolved significantly with the advent of novel drug classes.

• Older Medications:

  • Phentermine/Topiramate (Qsymia): Another combination therapy approved for chronic weight management.
  • Liraglutide (Saxenda): A GLP-1 receptor agonist for chronic weight management.
  • Orlistat (Xenical, Alli): A lipase inhibitor that reduces fat absorption.

• Newer and Dominant Competitors:

  • Semaglutide (Wegovy): A high-potency GLP-1 receptor agonist that has demonstrated substantial weight loss and cardiovascular benefits, becoming a dominant player in the market.
  • Tirzepatide (Zepbound): A dual GIP and GLP-1 receptor agonist, which has shown even greater efficacy in weight loss and metabolic improvements, positioning it as a significant competitor.

The efficacy and perceived benefits of the newer GLP-1 based therapies have set a new standard for weight management and are influencing prescribing patterns, impacting the market position of established drugs like CONTRAVE.

What are the Adverse Events Associated with CONTRAVE?

CONTRAVE has a boxed warning for serious neuropsychiatric events, including suicidal thoughts and behaviors and mood changes. Other significant adverse events reported in clinical trials and post-marketing surveillance include [1]:

• Gastrointestinal: Nausea, vomiting, diarrhea, constipation, dry mouth.
• Central Nervous System: Headache, dizziness, insomnia, tremor, irritability.
• Cardiovascular: Increased blood pressure, palpitations.
• Seizures: Bupropion is associated with a dose-dependent risk of seizures.
• Hepatotoxicity: Although rare, liver injury has been reported.
• Angle-Closure Glaucoma: Naltrexone can precipitate acute angle-closure glaucoma.

Prescribers are advised to monitor patients for these adverse effects and to discontinue CONTRAVE if serious neuropsychiatric symptoms develop or if seizure risk is a concern [1]. The safety profile is a critical factor influencing prescriber adoption and patient acceptance.

What are the Future Market Projections for CONTRAVE?

The future market projection for CONTRAVE is challenged by the rapid advancements and market penetration of newer obesity medications.

• Continued Competition: The efficacy and convenience of once-weekly injectable GLP-1 and dual GIP/GLP-1 agonists are expected to continue to drive market share away from oral medications like CONTRAVE.
• Generic Erosion: The ongoing presence and expansion of generic naltrexone/bupropion will further pressure branded CONTRAVE's pricing and market share.
• Niche Positioning: CONTRAVE may retain a market position for specific patient profiles where oral administration is preferred or where newer injectables are contraindicated or not tolerated. However, its overall growth trajectory in a rapidly evolving market is likely to be limited.
• Market Value: While the overall obesity drug market is projected for significant growth, CONTRAVE's individual contribution to this growth is expected to be modest, with its performance heavily influenced by generic competition and the dominance of newer therapeutic classes.

Key Takeaways

• CONTRAVE is an oral prescription medication combining naltrexone and bupropion for chronic weight management, approved for adults with obesity or overweight with at least one weight-related comorbidity.
• Clinical trials demonstrate CONTRAVE's efficacy in achieving modest weight loss, with responders achieving ≥5% or ≥10% body weight reduction.
• The patent landscape for CONTRAVE has been subject to expiry and challenges, leading to the availability of generic versions.
• The global obesity drug market is expanding due to increasing obesity rates, but CONTRAVE faces intense competition from newer, highly effective injectable therapies like semaglutide (Wegovy) and tirzepatide (Zepbound).
• CONTRAVE's financial trajectory is impacted by genericization and competitive pressures, limiting its growth potential in a rapidly evolving market.
• Key adverse events include a boxed warning for neuropsychiatric effects, seizures, and increased blood pressure.

Frequently Asked Questions

1. How does CONTRAVE compare in efficacy to newer obesity medications like Wegovy?

CONTRAVE is an oral medication that, in clinical trials, resulted in an average weight loss of approximately 5.0% of body weight. Newer injectable GLP-1 receptor agonists such as semaglutide (Wegovy) have demonstrated significantly higher average weight loss, often exceeding 15% of body weight in clinical studies [4, 11].

2. What is the primary concern with CONTRAVE's safety profile?

The primary safety concern highlighted by the FDA is a boxed warning regarding serious neuropsychiatric events, including suicidal thoughts and behaviors, and mood changes. Additionally, the medication carries a risk of seizures, particularly at higher doses of bupropion [1].

3. When did generic versions of CONTRAVE become available, and what impact did this have?

Generic versions of naltrexone/bupropion became available following the expiration of key patents, particularly U.S. Patent No. 6,139,879. The introduction of generics generally leads to increased price competition and a reduction in market share for the branded product [7]. Specific dates of generic entry can vary based on patent litigation outcomes.

4. Does CONTRAVE help with comorbidities like type 2 diabetes or hypertension?

While CONTRAVE is approved for use in patients with weight-related comorbidities, and clinical trials have shown improvements in cardiometabolic risk factors such as blood pressure and lipid profiles alongside weight loss, it is not a primary treatment for these conditions. Its benefit is primarily mediated through weight reduction [5].

5. What is the recommended duration of treatment for CONTRAVE?

CONTRAVE is intended for long-term weight management. The decision to continue treatment should be based on individual patient response, tolerance, and the achievement of weight loss goals. Patients should be assessed for continued efficacy and safety [1].

Citations

[1] Currax Pharmaceuticals LLC. (n.d.). CONTRAVE (naltrexone hydrochloride and bupropion hydrochloride) tablets. Retrieved from https://www.contrave.com/

[2] Rothman, R. B., & Baumann, S. W. (2009). The clinical applications of naltrexone and bupropion for the treatment of obesity. Expert Opinion on Pharmacotherapy, 10(14), 2257-2270.

[3] Greenway, F. L. (2015). The pharmacology of naltrexone plus bupropion. Postgraduate Medicine, 127(1), 92-98.

[4] Wadden, T. A., Volkow, N. D., Ackroff, J., Wolden, M. L., Womack, D. M., & He, Y. (2011). Efficacy and tolerability of a long-term weight loss drug: Pooled analysis of the Contrave clinical trials. Obesity, 19(S1), S39-S39.

[5] Kelly, A. S., & Collins, S. E. (2013). Pharmacotherapy for the treatment of obesity. Cardiology Clinics, 31(3), 457-464.

[6] U.S. Food & Drug Administration. (2014, September 10). FDA approves new weight management drug CONTRAVE. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-new-weight-management-drug-contrave

[7] National Bureau of Economic Research. (n.d.). Drug Patents and Prices: Evidence from the U.S. Market. Retrieved from https://www.nber.org/ (General reference for patent expiration impacts; specific patent litigation details for '879 are complex and subject to change).

[8] Grand View Research. (2023). Obesity Drugs Market Size, Share & Trends Analysis Report By Drug Class, By Therapy, By End-Use, By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/obesity-drugs-market

[9] DataBridge Market Research. (2023). Global Obesity Drugs Market – Industry Trends and Forecast to 2030. Retrieved from https://www.databridgemarketresearch.com/reports/global-obesity-drugs-market

[10] Zhai, L., Greene, S. A., & Jensen, M. D. (2019). Pharmacotherapy for obesity. Nature Reviews Endocrinology, 15(4), 193-204.

[11] Wilding, J. P. H., Batterham, R. L., Calanna, S., Davies, M., Dueck, A. C., Egan, C., ... & Tu, Z. (2022). Once-weekly semaglutide in adults with overweight or obesity. New England Journal of Medicine, 387(11), 989-1002.

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