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Federal Trade Commission
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Generated: February 21, 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, Zydus Pharms Usa Inc, Alvogen, Glaxosmithkline, Valeant Intl, Apotex Inc, Heritage Pharma, Teva, and Orexigen, and is included in fifty-one 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.
Summary for bupropion hydrochloride
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
Teva BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET;ORAL 075310-001 Nov 29, 1999 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sun Pharma Global BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 078866-001 Apr 6, 2010 AB1 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sandoz BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET;ORAL 075584-002 Feb 7, 2000 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Prinston Inc BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 202304-002 May 26, 2015 AB1 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sandoz BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 076845-001 Jul 14, 2005 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-001 Dec 30, 1985 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Torrent Pharms Ltd BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 203969-003 Oct 31, 2014 AB1 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 090942-002 Jul 14, 2010 AB3 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Heritage Pharma BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET;ORAL 206975-002 Aug 19, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Impax Labs BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 077415-001 Nov 26, 2008 AB3 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-003 May 14, 1997 ➤ Sign Up ➤ Sign Up
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-003 Dec 30, 1985 ➤ Sign Up ➤ Sign Up
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-003 Oct 4, 1996 ➤ Sign Up ➤ Sign Up
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-004 Jun 14, 2002 ➤ Sign Up ➤ Sign Up
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-001 Oct 4, 1996 ➤ Sign Up ➤ Sign Up
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-001 Dec 30, 1985 ➤ Sign Up ➤ Sign Up
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-001 Oct 4, 1996 ➤ Sign Up ➤ Sign Up
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-002 Oct 4, 1996 ➤ Sign Up ➤ Sign Up
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-002 May 14, 1997 ➤ Sign Up ➤ Sign Up
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-003 Dec 30, 1985 ➤ Sign Up ➤ Sign Up
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 ➤ Sign Up
6,143,327 Delayed release coated tablet of bupropion hydrochloride ➤ Sign Up
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 ➤ Sign Up PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2000 00018 Denmark ➤ Sign Up PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
C/GB00/019 United Kingdom ➤ Sign Up PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
McKinsey
US Army
Moodys
Cerilliant
Teva
Fish and Richardson
US Department of Justice
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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