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Serving leading biopharmaceutical companies globally:

Baxter
Merck
Medtronic
UBS
McKesson
Colorcon
Chinese Patent Office
Farmers Insurance
Boehringer Ingelheim
Teva

Generated: January 22, 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, Tech Organized, 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
Sun Pharma Global BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 078866-003 Apr 6, 2010 AB1 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Zydus Pharms Usa Inc BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 201567-001 Jan 17, 2014 AB3 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sinotherapeutics Inc BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 208652-001 Aug 21, 2017 AB3 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Orexigen CONTRAVE bupropion hydrochloride; naltrexone hydrochloride TABLET, EXTENDED RELEASE;ORAL 200063-001 Sep 10, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Invagen Pharms BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 206556-002 Aug 26, 2016 AB3 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 090325-001 Apr 8, 2010 AB1 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Jubilant Generics BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 207459-002 Jun 30, 2017 AB3 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 090325-002 Apr 8, 2010 AB1 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sun Pharma Global BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 078866-001 Apr 6, 2010 AB1 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Wockhardt Ltd BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 201331-002 Aug 30, 2012 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 018644-002 Dec 30, 1985 ➤ Subscribe ➤ Subscribe
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-001 Dec 30, 1985 ➤ Subscribe ➤ Subscribe
Glaxosmithkline ZYBAN bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020711-002 May 14, 1997 ➤ Subscribe ➤ Subscribe
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-003 Oct 4, 1996 ➤ Subscribe ➤ Subscribe
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-004 Jun 14, 2002 ➤ Subscribe ➤ Subscribe
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-003 Dec 30, 1985 ➤ Subscribe ➤ Subscribe
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-002 Oct 4, 1996 ➤ Subscribe ➤ Subscribe
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-003 Dec 30, 1985 ➤ Subscribe ➤ Subscribe
Glaxosmithkline WELLBUTRIN SR bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 020358-001 Oct 4, 1996 ➤ Subscribe ➤ Subscribe
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-002 Dec 30, 1985 ➤ Subscribe ➤ Subscribe
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 ➤ Subscribe
6,143,327 Delayed release coated tablet of bupropion hydrochloride ➤ Subscribe
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 ➤ Subscribe PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
C/GB00/019 United Kingdom ➤ Subscribe PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
2000 00018 Denmark ➤ Subscribe PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Cantor Fitzgerald
Colorcon
Medtronic
Moodys
Citi
Federal Trade Commission
McKesson
Daiichi Sankyo

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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