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Last Updated: August 5, 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 freedom to operate?

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
Nederlandse Obesitas KliniekPhase 4
Zuyderland Medisch CentrumPhase 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 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
Alembic Pharms Ltd BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET;ORAL 203013-001 Jun 8, 2018 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 090325-003 Apr 8, 2010 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Invagen Pharms BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 206674-002 Feb 9, 2016 AB1 RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Nalpropion CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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 020358-004 Jun 14, 2002 ⤷  Try it Free ⤷  Try it Free
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-003 May 14, 1997 ⤷  Try it Free ⤷  Try it Free
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-002 Oct 4, 1996 ⤷  Try it Free ⤷  Try it Free
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-001 Dec 30, 1985 ⤷  Try it Free ⤷  Try it Free
>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 132017000142109 Italy ⤷  Try it Free PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
2316456 122017000109 Germany ⤷  Try it Free 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
2316456 300918 Netherlands ⤷  Try it Free 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
0467488 SPC/GB00/019 United Kingdom ⤷  Try it Free PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
McKinsey
Harvard Business School
Medtronic
Express Scripts
Baxter

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