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Last Updated: July 13, 2020

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BUPROPION HYDROCHLORIDE Drug Profile


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Which patents cover Bupropion Hydrochloride, and what generic alternatives are available?

Bupropion Hydrochloride is a drug 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, Alembic Pharms Ltd, Apnar Pharma Lp, Apotex Inc, Cadila Pharms Ltd, Heritage Pharma, Invatech, and Micro Labs. and is included in fifty-three NDAs.

The generic ingredient in BUPROPION HYDROCHLORIDE is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Sixty-seven suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Bupropion Hydrochloride

A generic version of BUPROPION HYDROCHLORIDE was approved as bupropion hydrochloride by APNAR PHARMA LP on February 7th, 2000.

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Drug patent expirations by year for BUPROPION HYDROCHLORIDE
Recent Clinical Trials for BUPROPION HYDROCHLORIDE

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SponsorPhase
Oslo University HospitalPhase 4
Vanderbilt University Medical CenterPhase 2
University of WashingtonPhase 3

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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 077285-001 Nov 26, 2008 AB3 RX No No   Start Trial   Start Trial   Start Trial
Invagen Pharms BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET;ORAL 207389-002 Sep 18, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 090942-001 Jul 14, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Jubilant Generics BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 202775-001 Oct 11, 2013 DISCN 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

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
Johnson and Johnson
Colorcon
Medtronic
Merck

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