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 forty-five patent family members in forty-four 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 March 26, 2025. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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:	245
US Patents:	19
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	21
Patent Applications:	162
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:

7,375,111

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
Currax Pharmaceuticals	Phase 4
Novo Nordisk A/S	Phase 4
University of California, Los Angeles	Early Phase 1

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.

This potential generic entry date is based on patent 7,375,111.

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
Nalpropion	CONTRAVE	bupropion hydrochloride; naltrexone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200063-001	Sep 10, 2014		RX	Yes	Yes	10,835,527
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 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	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	8,815,889

International Patents for CONTRAVE

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

Country	Patent Number	Title	Estimated Expiration
Mexico	2016007231
Japan	2023086769	過体重および肥満を治療する方法 (METHODS OF TREATING OVERWEIGHT AND OBESITY)
Mexico	2019011209	COMPOSICIONES DE LIBERACION SOSTENIDA DE NALTREXONA Y BUPROPION PARA USARSE EN EL TRATAMIENTO DE SOBREPESO Y OBESIDAD. (METHODS OF TREATING OVERWEIGHT AND OBESITY.)
South Korea	101971218
China	110893181	治疗超重和肥胖症的方法 (Methods of treating overweight and obesity)
European Patent Office	3659604	MÉTHODES D'AMAIGRISSEMENTU POUR DES PATIENTS SOUFFRANT D'UNE DÉPRESSION SÉVÈRE (METHODS OF PROVIDING WEIGHT LOSS THERAPY IN PATIENTS WITH MAJOR DEPRESSION)

Supplementary Protection Certificates for CONTRAVE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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
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	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	2017C/064	Belgium		PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330

Market Dynamics and Financial Trajectory for CONTRAVE (Naltrexone-Bupropion)

Introduction

CONTRAVE, a combination of naltrexone and bupropion, is a prescription weight loss medication that has been a significant player in the anti-obesity drug market. Here, we will delve into the market dynamics and financial trajectory of CONTRAVE, highlighting its performance, challenges, and future outlook.

Market Overview

The global anti-obesity medication market is experiencing robust growth, driven by the increasing prevalence of obesity. This trend is expected to continue, with the market projected to reach USD 4.8 billion by 2030, growing at a CAGR of 8.7% from 2023 to 2030[4].

CONTRAVE Market Performance

Historical Sales and Growth

In the first quarter of 2017, Orexigen Therapeutics, the manufacturer of CONTRAVE, reported significant growth in U.S. sales. The company achieved a 39% increase in prescriptions compared to Q4 2016 and a 22% growth in average net revenue per unit sold compared to the first quarter of 2016. This growth was attributed to the company's patient-centric campaign and the expansion of its telemedicine pilot program[2].

Revenue and Prescription Volume

During the first quarter of 2017, Orexigen reported $19.1 million in revenue, with $14.8 million coming from net sales of CONTRAVE in the United States. The total prescriptions of CONTRAVE filled in the first quarter of 2017 were 195,920, showing a slight increase from the 192,005 prescriptions filled in the first quarter of 2016[2].

Competitive Landscape

The anti-obesity drug market is highly competitive, with several key players including Novo Nordisk, GSK, Novartis, and VIVUS LLC. CONTRAVE faces competition from other approved and emerging therapies. For instance, Saxenda (semaglutide) currently dominates the market, but newer drugs like semaglutide and other pipeline products are expected to provide significant competition to CONTRAVE[3][4].

Regulatory and Developmental Activities

CONTRAVE has undergone various regulatory milestones and developmental activities. The drug has been approved for weight loss in several countries, and its market size is forecasted to grow in key regions such as the United States, Germany, France, Spain, Italy, the UK, and Japan. Detailed analyses of forecasted sales data from 2019 to 2032 provide insights into the drug's market performance and potential[1].

Financial Trajectory

Revenue Projections

The market size for CONTRAVE is expected to grow significantly over the coming years. For example, in the United States, the market size for CONTRAVE is projected to increase substantially from 2019 to 2032. Similar growth trends are expected in other major markets like Germany, France, and the UK[1].

Operating Expenses and Net Loss

Despite the growth in sales, Orexigen faced significant operating expenses in 2017, primarily related to establishing and managing sales, marketing, and distribution capabilities. The company reported a net loss of $69.1 million in the first quarter of 2017, compared to a net loss of $22.3 million in the first quarter of 2016. However, the company had $126.6 million in cash, restricted cash, and marketable securities as of March 31, 2017[2].

Market Drivers and Challenges

Rising Obesity Prevalence

The escalating prevalence of obesity is a major driver for the anti-obesity drug market. Governments and healthcare organizations are prioritizing obesity prevention and treatment, which is expected to drive the market's growth[3].

Regulatory Challenges

Despite the positive outlook, the anti-obesity drug market faces regulatory challenges. For instance, the launch of new therapies and the stringent regulatory environment can impact the market dynamics of existing drugs like CONTRAVE[4].

Patient and Physician Reluctance

Reluctance among patients, physicians, and payers due to past setbacks with anti-obesity drugs can also pose challenges to the market growth of CONTRAVE. However, ongoing efforts in new drug development and innovative marketing strategies are expected to mitigate these challenges[4].

Strategic Initiatives and Partnerships

Commercial Strategies

Orexigen has implemented various commercial strategies to boost the sales of CONTRAVE. These include a comprehensive digital and social-media marketing strategy, the expansion of telemedicine services, and distribution agreements with partners in different regions[2].

Global Expansion

The company has also worked on expanding the reach of CONTRAVE through partnerships. For example, Orexigen executed distribution agreements for the commercialization of Mysimba (the European brand name for CONTRAVE) in several countries, including Italy, Denmark, Finland, Norway, Sweden, and Iceland[2].

Future Outlook

Market Growth

The anti-obesity medication market, including CONTRAVE, is expected to grow significantly due to the increasing prevalence of obesity and the need for effective treatments. The market is projected to reach USD 77.24 billion by 2030, expanding at a CAGR of 31.66% from 2024 to 2030[3].

Competitive Positioning

While CONTRAVE faces stiff competition, its unique mechanism of action and established market presence position it as a viable option in the anti-obesity drug market. Newer drugs and therapies will continue to shape the competitive landscape, but CONTRAVE is expected to maintain its relevance through ongoing marketing efforts and strategic partnerships[1][4].

Key Takeaways

• Market Growth: The anti-obesity medication market is growing rapidly, driven by the increasing prevalence of obesity.
• Competitive Landscape: CONTRAVE faces competition from other approved and emerging therapies but remains a significant player.
• Financial Performance: Despite growth in sales, Orexigen has faced significant operating expenses and net losses.
• Regulatory and Developmental Activities: CONTRAVE has undergone various regulatory milestones and developmental activities.
• Strategic Initiatives: Orexigen has implemented several commercial strategies and partnerships to boost CONTRAVE's sales.

FAQs

Q: What is the projected market size for the anti-obesity medication market by 2030? A: The global anti-obesity medication market is projected to reach USD 77.24 billion by 2030, expanding at a CAGR of 31.66% from 2024 to 2030[3].

Q: How has CONTRAVE performed in terms of sales and prescription volume? A: In the first quarter of 2017, CONTRAVE achieved a 39% increase in prescriptions and a 22% growth in average net revenue per unit sold compared to the first quarter of 2016[2].

Q: What are the main challenges faced by CONTRAVE in the market? A: CONTRAVE faces challenges such as competition from other therapies, regulatory hurdles, and reluctance among patients, physicians, and payers[4].

Q: What strategic initiatives has Orexigen taken to boost CONTRAVE's sales? A: Orexigen has implemented a comprehensive digital and social-media marketing strategy, expanded telemedicine services, and executed distribution agreements with partners in different regions[2].

Q: How does the future outlook for CONTRAVE look in the anti-obesity drug market? A: Despite competition, CONTRAVE is expected to maintain its relevance through ongoing marketing efforts and strategic partnerships, with the market projected to grow significantly due to the increasing prevalence of obesity[1][3].

Sources

1. ResearchAndMarkets.com: CONTRAVE (Naltrexon-Bupropion), Drug Insight and Market Forecast.
2. Biospace: Orexigen Reports Financial Results For The First Quarter Ended March 31, 2017.
3. GlobeNewswire: Global Anti-obesity Medication Market Trends Analysis Report 2024-2030.
4. GlobeNewswire: Anti-Obesity Drugs Global Strategic Business Report 2024.