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Last Updated: October 17, 2019

DrugPatentWatch Database Preview

CONTRAVE Drug Profile

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Which patents cover Contrave, and when can generic versions of Contrave launch?

Contrave is a drug marketed by Nalpropion and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventy patent family members in thirty-three 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.

Drug patent expirations by year for CONTRAVE
Drug Prices for CONTRAVE

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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 NebraskaPhase 4
Lindner Center of HOPEPhase 2
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 2/Phase 3

See all CONTRAVE clinical trials

Recent Litigation for CONTRAVE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Orexigen Therapeutics, Inc. v. Actavis Laboratories FL, Inc..2015-06-03

See all CONTRAVE litigation

Synonyms for CONTRAVE
1201668-08-7
Bupropion / naltrexone
Bupropion mixture with naltrexone
Mysimba
Naltrexone / bupropion
Naltrexone/bupropion
S900005400
SCHEMBL15633271

US Patents and Regulatory Information for CONTRAVE

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   Start Trial   Start Trial   Start Trial
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for CONTRAVE
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablets 8 mg/90 mg ➤ Subscribe   Start Trial

Supplementary Protection Certificates for CONTRAVE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 C20170044 00252 Estonia   Start Trial PRODUCT NAME: NALTREKSOON/BUPROPIOON;REG NO/DATE: EU/1/14/988 30.03.2015
0656775 CR 2000 00018 Denmark   Start Trial PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
2316456 CA 2017 00062 Denmark   Start Trial 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 LUC00054 Luxembourg   Start Trial 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 122017000109 Germany   Start Trial PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 20150326
2316456 2017C/064 Belgium   Start Trial PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2316456 17C1058 France   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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