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Last Updated: June 22, 2021

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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, Adaptis, Anbison Lab, Anchen 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, Bausch, Alembic Pharms Ltd, Apnar Pharma Lp, Apotex Inc, Cadila Pharms Ltd, Heritage Pharma, Invatech, Micro Labs, and Nalpropion, and is included in sixty-one NDAs. There are fifteen 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Zuyderland Medisch CentrumPhase 4
Nederlandse Obesitas KliniekPhase 4
Blade TherapeuticsPhase 1

See all bupropion hydrochloride clinical trials

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 SR TABLET, EXTENDED RELEASE;ORAL bupropion hydrochloride 020358
ZYBAN TABLET, EXTENDED RELEASE;ORAL bupropion hydrochloride 020711
WELLBUTRIN TABLET;ORAL bupropion hydrochloride 018644

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
Impax Labs BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 077415-001 Nov 26, 2008 AB3 RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Heritage Pharma BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET;ORAL 075310-002 Nov 29, 1999 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Adaptis BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 211020-002 Jan 28, 2019 AB3 RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Heritage Pharma BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET;ORAL 206975-001 Aug 19, 2016 AB RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Mylan BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 090942-001 Jul 14, 2010 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Bausch WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 021515-002 Aug 28, 2003 AB3 RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
>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

Supplementary Protection Certificates for bupropion hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 1790064-8 Sweden   Try Before You Buy 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
2316456 132017000142109 Italy   Try Before You Buy PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
2316456 2017C/064 Belgium   Try Before You Buy PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
0656775 CR 2000 00018 Denmark   Try Before You Buy PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
0467488 SPC/GB00/019 United Kingdom   Try Before You Buy PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
2316456 17C1058 France   Try Before You Buy 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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