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Last Updated: May 26, 2022

CONTRAVE Drug Patent Profile


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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 thirty-seven patent family members in forty-one countries.

The generic ingredient in CONTRAVE is bupropion hydrochloride; naltrexone hydrochloride. There are thirty-eight drug master file entries for this compound. Three suppliers are 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 April 21, 2024. 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

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Drug patent expirations by year for CONTRAVE
Drug Prices for CONTRAVE

See drug prices for CONTRAVE

DrugPatentWatch® Estimated Generic Entry Opportunity Date for CONTRAVE
Generic Entry Date for CONTRAVE*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
University of California, Los AngelesEarly Phase 1
Zuyderland Medisch CentrumPhase 4
Nederlandse Obesitas KliniekPhase 4

See all CONTRAVE clinical trials

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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CONTRAVE is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting CONTRAVE

Compositions and methods for weight loss in at risk patient populations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY

Methods for administering weight loss medications
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE

Methods of treating overweight and obesity
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY

Compositions and methods for weight loss in at risk patient populations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY

Methods of providing weight loss therapy in patients with major depression
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY

Methods of treating overweight and obesity
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY

Compositions for affecting weight loss
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY

Compositions for affecting weight loss
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions for affecting weight loss
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY

Layered pharmaceutical formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Layered pharmaceutical formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF NALTREXONE AND BUPROPION IN A LAYERED FORMULATION FOR CHRONIC WEIGHT MANAGEMENT FOR AFFECTING WEIGHT LOSS

Methods for administering weight loss medications
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE

Compositions and methods for increasing insulin sensitivity
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR EFFECT ON BLOOD GLUCOSE PARAMETERS IN PATIENTS WITH INSULIN RESISTANCE

Sustained release formulation of naltrexone
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF NALTREXONE AND BUPROPION IN EXTENDED-RELEASE FORM FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY

Sustained release formulation of naltrexone
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF NALTREXONE AND BUPROPION IN EXTENDED-RELEASE FORM FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY

Methods for administering weight loss medications
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE

Methods of providing weight loss therapy in patients with major depression
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF NALTREXONE AND BUPROPION FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY IN PATIENTS WITH MAJOR DEPRESSIVE DISORDER

Methods of treating overweight and obesity
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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:

Australia

Patent: 04233846
Estimated Expiration: See Plans and Pricing

Patent: 10221801
Estimated Expiration: See Plans and Pricing

Austria

Patent: 8698
Estimated Expiration: See Plans and Pricing

Canada

Patent: 22708
Estimated Expiration: See Plans and Pricing

China

Patent: 84221
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 19418
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 17832
Estimated Expiration: See Plans and Pricing

Patent: 16456
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 17832
Estimated Expiration: See Plans and Pricing

Patent: 70096
Estimated Expiration: See Plans and Pricing

Patent: 16456
Estimated Expiration: See Plans and Pricing

Patent: 81628
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2004012403
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 88850
Estimated Expiration: See Plans and Pricing

Patent: 52078
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 34290
Estimated Expiration: See Plans and Pricing

Patent: 700052
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1519
Estimated Expiration: See Plans and Pricing

Patent: 7935
Estimated Expiration: See Plans and Pricing

Patent: 7936
Estimated Expiration: See Plans and Pricing

Japan

Patent: 43948
Estimated Expiration: See Plans and Pricing

Patent: 06525332
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 0054
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 05011557
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 0918
Estimated Expiration: See Plans and Pricing

Poland

Patent: 17832
Estimated Expiration: See Plans and Pricing

Patent: 16456
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 17832
Estimated Expiration: See Plans and Pricing

Patent: 16456
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 50327
Estimated Expiration: See Plans and Pricing

Patent: 05132453
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 16456
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1167579
Estimated Expiration: See Plans and Pricing

Patent: 060009871
Estimated Expiration: See Plans and Pricing

Spain

Patent: 03085
Estimated Expiration: See Plans and Pricing

Patent: 39579
Estimated Expiration: See Plans and Pricing

Patent: 60464
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 56701
Estimated Expiration: See Plans and Pricing

Patent: 0509928
Estimated Expiration: See Plans and Pricing

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
Russian Federation 2711638 КОМПОЗИЦИИ И СПОСОБЫ ДЛЯ УМЕНЬШЕНИЯ СЕРЬЕЗНЫХ НЕБЛАГОПРИЯТНЫХ СЕРДЕЧНО-СОСУДИСТЫХ ЯВЛЕНИЙ (COMPOSITIONS AND METHODS FOR REDUCING SERIOUS ADVERSE CARDIOVASCULAR EVENTS) See Plans and Pricing
Japan 5980840 See Plans and Pricing
Japan 2014005310 SUSTAINED RELEASE FORMULATION OF NALTREXONE See Plans and Pricing
Japan 2009516744 See Plans and Pricing
European Patent Office 1870096 Compositions pour influencer la perte de poids (Compositions for affecting weight loss) See Plans and Pricing
Canada 2785822 METHODES PERMETTANT DE FAIRE PERDRE DU POIDS A DES PATIENTS SOUFFRANT D'UNE DEPRESSION SEVERE (METHODS OF PROVIDING WEIGHT LOSS THERAPY IN PATIENTS WITH MAJOR DEPRESSION) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CONTRAVE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 349 22-2017 Slovakia See Plans and Pricing 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
0656775 28/2000 Austria See Plans and Pricing PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2316456 132017000142109 Italy See Plans and Pricing PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
2316456 C 2017 047 Romania See Plans and Pricing PRODUCT NAME: COMBINATIE DE NALTREXONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA, IN PARTICULAR CLORHIDRAT DE NALTREXONA SI BUPROPION SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, IN PARTICULAR CLORHIDRAT DE BUPROPION; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF NATIONAL AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
2316456 C201730057 Spain See Plans and Pricing PRODUCT NAME: NALTREXONA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA, EN PARTICULAR CLORHIDRATO DE NALTREXONA, Y BUPROPION O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR CLORHIDRATO DE BUPROPION.; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
2316456 300918 Netherlands See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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McKinsey
Colorcon
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.