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Last Updated: June 28, 2022

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, Aurobindo Pharma Usa, Epic Pharma, Granules, 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, Almatica, 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-two NDAs. There are twenty 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 drug master file entries for bupropion hydrochloride. Sixty-five suppliers are listed for this compound.

Recent Clinical Trials for bupropion hydrochloride

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

SponsorPhase
Kenya Medical Research InstitutePhase 4
All India Institute of Medical Sciences, BhubaneswarPhase 4
Valeant Pharmaceuticals International, Inc.Phase 4

See all bupropion hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for bupropion hydrochloride
Paragraph IV (Patent) Challenges for BUPROPION HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FORFIVO XL Extended-release Tablets bupropion hydrochloride 450 mg 022497 1 2013-02-28
WELLBUTRIN XL Extended-release Tablets bupropion hydrochloride 150 mg and 300 mg 021515 1 2004-09-21

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
Wockhardt Ltd BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 202189-001 Nov 21, 2012 AB3 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Invagen Pharms BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 206674-001 Feb 9, 2016 AB1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Usa BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 090942-002 Jul 14, 2010 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-002 Oct 4, 1996 AB1 RX Yes No 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

Expired US Patents for bupropion hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-003 Oct 4, 1996 See Plans and Pricing See Plans and Pricing
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-003 Dec 30, 1985 See Plans and Pricing See Plans and Pricing
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-003 Oct 4, 1996 See Plans and Pricing See Plans and Pricing
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-003 Dec 30, 1985 See Plans and Pricing See Plans and Pricing
>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 2017C/064 Belgium See Plans and Pricing PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
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 CR 2000 00018 Denmark See Plans and Pricing PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
0656775 28/2000 Austria See Plans and Pricing PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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