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Serving leading biopharmaceutical companies globally:

Harvard Business School
UBS
Julphar
Chubb
Johnson and Johnson
Covington
QuintilesIMS
US Army
Teva
Baxter

Generated: December 12, 2017

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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 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 and three supplementary protection certificates in three countries.

There are thirty-seven drug master file entries for bupropion hydrochloride. Seventy-five suppliers are listed for this compound.

Pharmacology for bupropion hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Sciegen Pharms IncBUPROPION HYDROCHLORIDEbupropion hydrochlorideTABLET, EXTENDED RELEASE;ORAL205794-002Mar 1, 2016AB1RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
SandozBUPROPION HYDROCHLORIDEbupropion hydrochlorideTABLET;ORAL075584-002Feb 7, 2000ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Actavis Labs Fl IncBUPROPION HYDROCHLORIDEbupropion hydrochlorideTABLET, EXTENDED RELEASE;ORAL077715-002Jun 13, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
OrexigenCONTRAVEbupropion hydrochloride; naltrexone hydrochlorideTABLET, EXTENDED RELEASE;ORAL200063-001Sep 10, 2014RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Invagen PharmsBUPROPION HYDROCHLORIDEbupropion hydrochlorideTABLET, EXTENDED RELEASE;ORAL206674-002Feb 9, 2016AB1RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
SandozBUPROPION HYDROCHLORIDEbupropion hydrochlorideTABLET, EXTENDED RELEASE;ORAL076834-001Jul 14, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
AlvogenFORFIVO XLbupropion hydrochlorideTABLET, EXTENDED RELEASE;ORAL022497-001Nov 10, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sinotherapeutics IncBUPROPION HYDROCHLORIDEbupropion hydrochlorideTABLET, EXTENDED RELEASE;ORAL208652-001Aug 21, 2017AB3RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
MylanBUPROPION HYDROCHLORIDEbupropion hydrochlorideTABLET, EXTENDED RELEASE;ORAL090325-001Apr 8, 2010AB1RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Actavis Labs Fl IncBUPROPION HYDROCHLORIDEbupropion hydrochlorideTABLET, EXTENDED RELEASE;ORAL077715-001Nov 26, 2008AB3RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: bupropion hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
GlaxosmithklineWELLBUTRIN SRbupropion hydrochlorideTABLET, EXTENDED RELEASE;ORAL020358-004Jun 14, 2002► Subscribe► Subscribe
GlaxosmithklineWELLBUTRIN SRbupropion hydrochlorideTABLET, EXTENDED RELEASE;ORAL020358-004Jun 14, 2002► Subscribe► Subscribe
GlaxosmithklineWELLBUTRIN SRbupropion hydrochlorideTABLET, EXTENDED RELEASE;ORAL020358-002Oct 4, 1996► Subscribe► Subscribe
GlaxosmithklineZYBANbupropion hydrochlorideTABLET, EXTENDED RELEASE;ORAL020711-002May 14, 1997► Subscribe► Subscribe
GlaxosmithklineWELLBUTRINbupropion hydrochlorideTABLET;ORAL018644-002Dec 30, 1985► Subscribe► Subscribe
GlaxosmithklineWELLBUTRINbupropion hydrochlorideTABLET;ORAL018644-001Dec 30, 1985► Subscribe► Subscribe
GlaxosmithklineWELLBUTRINbupropion hydrochlorideTABLET;ORAL018644-001Dec 30, 1985► Subscribe► Subscribe
GlaxosmithklineWELLBUTRIN SRbupropion hydrochlorideTABLET, EXTENDED RELEASE;ORAL020358-003Oct 4, 1996► Subscribe► Subscribe
GlaxosmithklineWELLBUTRINbupropion hydrochlorideTABLET;ORAL018644-001Dec 30, 1985► Subscribe► Subscribe
GlaxosmithklineWELLBUTRINbupropion hydrochlorideTABLET;ORAL018644-002Dec 30, 1985► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,703,191Controlled-release pharmaceutical tablets► Subscribe
6,143,327 Delayed release coated tablet of bupropion hydrochloride► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: bupropion hydrochloride

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2008038155► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: BUPROPION HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2000 00018Denmark► SubscribePRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
/2000Austria► SubscribePRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
C/GB00/019United Kingdom► SubscribePRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Chinese Patent Office
Johnson and Johnson
Accenture
US Department of Justice
Novartis
QuintilesIMS
Teva
Argus Health
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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