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Last Updated: March 24, 2023

Bupropion hydrochloride; naltrexone hydrochloride - Generic Drug Details


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What are the generic sources for bupropion hydrochloride; naltrexone hydrochloride and what is the scope of patent protection?

Bupropion hydrochloride; naltrexone hydrochloride is the generic ingredient in one branded drug marketed by Nalpropion and is included in one NDA. There are twenty patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bupropion hydrochloride; naltrexone hydrochloride has two hundred and fifty-seven patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for bupropion hydrochloride; naltrexone hydrochloride
Recent Clinical Trials for bupropion hydrochloride; naltrexone hydrochloride

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 bupropion hydrochloride; naltrexone hydrochloride clinical trials

Pharmacology for bupropion hydrochloride; naltrexone hydrochloride
Paragraph IV (Patent) Challenges for BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
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 bupropion hydrochloride; naltrexone hydrochloride

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 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 bupropion hydrochloride; naltrexone hydrochloride

Country Patent Number Title Estimated Expiration
Singapore 10201808055Q COMPOSITIONS AND METHODS FOR REDUCING MAJOR ADVERSE CARDIOVASCULAR EVENTS See Plans and Pricing
Spain 2749800 See Plans and Pricing
Mexico 344303 METODOS PARA PROVEER TERAPIA DE PERDIDA DE PESO EN PACIENTES CON DEPRESION MAYOR. (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 bupropion hydrochloride; naltrexone hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 LUC00054 Luxembourg See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Merck
Mallinckrodt
Johnson and Johnson
Medtronic
McKesson

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