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Last Updated: March 28, 2024

Bupropion hydrochloride - Generic Drug Details


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

Bupropion hydrochloride is the generic ingredient in eight branded drugs marketed by Accord Hlthcare, Actavis Labs Fl Inc, Anbison Lab, Anchen Pharms, Annora Pharma, Aurobindo Pharma Usa, Epic Pharma Llc, Granules, Graviti Pharms, Impax Labs, Invagen Pharms, Jubilant Generics, Lupin Ltd, Mylan, Prinston Inc, Sandoz, Sciegen Pharms Inc, Scinopharm Taiwan, Sinotherapeutics Inc, Sun Pharm, Torrent, Watson Labs Inc, Wockhardt Ltd, Yichang Humanwell, Zhejiang Jutai Pharm, Zydus Pharms, Twi Pharms, Glaxosmithkline, Bausch, Alembic, Apnar Pharma Lp, Apotex Inc, Cadila Pharms Ltd, Heritage Pharma, Invatech, Micro Labs, Axsome, and Nalpropion, and is included in sixty-five NDAs. There are one hundred and thirty-three 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. Seventy-five suppliers are listed for this compound.

Summary for bupropion hydrochloride
International Patents:1
US Patents:133
Tradenames:8
Applicants:38
NDAs:65
Drug Master File Entries: 30
Finished Product Suppliers / Packagers: 75
Raw Ingredient (Bulk) Api Vendors: 137
Clinical Trials: 377
Patent Applications: 1,710
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in bupropion hydrochloride?bupropion hydrochloride excipients list
DailyMed Link:bupropion hydrochloride at DailyMed
Recent Clinical Trials for bupropion hydrochloride

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

SponsorPhase
Mclean HospitalPhase 4
Kenya Medical Research InstitutePhase 4
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da SaudePhase 2

See all bupropion hydrochloride clinical trials

Pharmacology 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
Zhejiang Jutai Pharm BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 211200-001 Sep 5, 2019 AB3 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Axsome AUVELITY bupropion hydrochloride; dextromethorphan hydrobromide TABLET, EXTENDED RELEASE;ORAL 215430-001 Aug 18, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Graviti Pharms BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 211020-001 Jan 28, 2019 AB3 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Axsome AUVELITY bupropion hydrochloride; dextromethorphan hydrobromide TABLET, EXTENDED RELEASE;ORAL 215430-001 Aug 18, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-003 Dec 30, 1985 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-004 Jun 14, 2002 ⤷  Try a Trial ⤷  Try a Trial
Bausch WELLBUTRIN XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 021515-002 Aug 28, 2003 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-003 Dec 30, 1985 ⤷  Try a Trial ⤷  Try a 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 122017000109 Germany ⤷  Try a 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
0656775 CR 2000 00018 Denmark ⤷  Try a Trial PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
2316456 CA 2017 00062 Denmark ⤷  Try a 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 300918 Netherlands ⤷  Try a Trial PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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