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Last Updated: July 6, 2020

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Bupropion hydrochloride - Generic Drug Details

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

Bupropion hydrochloride is the generic ingredient in seven branded drugs marketed by Accord Hlthcare, Actavis Labs Fl Inc, Anbison Lab, Anchen Pharms, Graviti Pharms, Impax Labs, Invagen Pharms, Jubilant Generics, Lupin Ltd, Mylan, Prinston Inc, Sandoz, Sandoz Inc, Sciegen Pharms Inc, Sinotherapeutics Inc, Sun Pharm, Torrent, Twi Pharms, Watson Labs Inc, Wockhardt Ltd, Yichang Humanwell, Zhejiang Jutai Pharm, Zydus Pharms, Alvogen, Glaxosmithkline, Valeant Intl, Alembic Pharms Ltd, Apnar Pharma Lp, Apotex Inc, Cadila Pharms Ltd, Heritage Pharma, Invatech, Micro Labs, and Nalpropion, and is included in fifty-nine NDAs. There are thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bupropion hydrochloride has one patent family member in one country.

There are thirty-eight drug master file entries for bupropion hydrochloride. Sixty-six suppliers are listed for this compound.

Recent Clinical Trials for bupropion hydrochloride

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SponsorPhase
Oslo University HospitalPhase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 2
Vanderbilt University Medical CenterPhase 2

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Pharmacology for bupropion hydrochloride
Paragraph IV (Patent) Challenges for BUPROPION HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
FORFIVO XL TABLET, EXTENDED RELEASE;ORAL bupropion hydrochloride 022497 2013-02-28
WELLBUTRIN XL TABLET, EXTENDED RELEASE;ORAL bupropion hydrochloride 021515 2004-09-21
WELLBUTRIN TABLET;ORAL bupropion hydrochloride 018644
WELLBUTRIN SR TABLET, EXTENDED RELEASE;ORAL bupropion hydrochloride 020358
ZYBAN TABLET, EXTENDED RELEASE;ORAL bupropion hydrochloride 020711

US Patents and Regulatory Information for bupropion hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs Inc BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 077455-001 Jul 19, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Heritage Pharma BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET;ORAL 206975-002 Aug 19, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Anchen Pharms BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 091520-001 Jun 9, 2011 AB2 RX No No   Start Trial   Start Trial   Start Trial
Sciegen Pharms Inc BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 206122-001 Aug 17, 2016 AB2 RX No No   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

Expired US Patents for bupropion hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Intl WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 021515-001 Aug 28, 2003   Start Trial   Start Trial
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-002 Dec 30, 1985   Start Trial   Start Trial
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-004 Jun 14, 2002   Start Trial   Start Trial
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-003 Dec 30, 1985   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for bupropion hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 2017/059 Ireland   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; REGISTRATION NO/DATE: EU/1/14/988 20150326
0656775 28/2000 Austria   Start Trial PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
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 C 2017 047 Romania   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Baxter
Express Scripts
Mallinckrodt
McKinsey

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