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
Summary for CONTRAVE
International Patents: | 237 |
US Patents: | 19 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 3 |
Clinical Trials: | 19 |
Patent Applications: | 258 |
Formulation / Manufacturing: | see details |
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 |


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
Sponsor | Phase |
---|---|
University of California, Los Angeles | Early Phase 1 |
Zuyderland Medisch Centrum | Phase 4 |
Nederlandse Obesitas Kliniek | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes 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 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
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 |