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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Cantor Fitzgerald
Colorcon
Healthtrust
Baxter
Medtronic
Teva
Fuji
Fish and Richardson

Generated: July 20, 2018

DrugPatentWatch Database Preview

Bupropion hydrochloride - Generic Drug Details

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What are the generic sources for bupropion hydrochloride and what is the scope of bupropion hydrochloride freedom to operate?

Bupropion hydrochloride
is the generic ingredient in seven branded drugs marketed by Actavis Labs Fl Inc, Anbison Lab Co Ltd, Anchen Pharms, Impax Labs, Invagen Pharms, Jubilant Generics, Lupin Ltd, Mylan, Prinston Inc, Sandoz, Sandoz Inc, Sciegen Pharms Inc, Sinotherapeutics Inc, Sun Pharma Global, Torrent Pharms Ltd, Twi Pharms Inc, Watson Labs Inc, Wockhardt Ltd, Yichang Humanwell, Zydus Pharms Usa Inc, Alvogen, Glaxosmithkline, Valeant Intl, Alembic Pharms Ltd, Apotex Inc, Heritage Pharma, Teva, and Orexigen, and is included in fifty-three NDAs. There are twelve 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. Seventy-eight suppliers are listed for this compound.
Pharmacology for bupropion hydrochloride

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
Actavis Labs Fl Inc BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 079095-002 Mar 24, 2009 AB1 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sandoz BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 075932-003 Jun 22, 2005 AB1 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Orexigen CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sinotherapeutics Inc BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 208652-001 Aug 21, 2017 AB3 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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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 Free Trial ➤ Try a Free Trial
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-003 Dec 30, 1985 ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-003 Oct 4, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-001 Dec 30, 1985 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for bupropion hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,703,191 Controlled-release pharmaceutical tablets ➤ Try a Free Trial
6,143,327 Delayed release coated tablet of bupropion hydrochloride ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for bupropion hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2000 Austria ➤ Try a Free Trial PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2017000109 Germany ➤ Try a Free 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
C/GB00/019 United Kingdom ➤ Try a Free Trial PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
0918 Netherlands ➤ Try a Free 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Accenture
Daiichi Sankyo
Cantor Fitzgerald
Express Scripts
Boehringer Ingelheim
Colorcon
Teva
US Department of Justice

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