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Generated: October 22, 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 Prinston Inc, Teva, Impax Labs, Glaxosmithkline, Sandoz, Actavis Labs Fl Inc, Valeant Intl, Anchen Pharms, Tech Organized, Anbison Lab Co Ltd, Mylan, Wockhardt Ltd, Apotex Inc, Sinotherapeutics Inc, Watson Labs Inc, Invagen Pharms, Jubilant Generics, Sun Pharma Global, Zydus Pharms Usa Inc, Torrent Pharms Ltd, Sandoz Inc, Heritage Pharma, Sciegen Pharms Inc, Lupin Ltd, Alvogen, and Orexigen, and is included in fifty 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.

Summary for Generic Name: bupropion hydrochloride

US Patents:12
Tradenames:7
Applicants:26
NDAs:50
Drug Master File Entries: see list37
Suppliers / Packagers: see list75
Bulk Api Vendors: see list79
Clinical Trials: see list2,528
Patent Applications: see list1,167
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:bupropion hydrochloride at DailyMed

Pharmacology for Ingredient: bupropion hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL075932-003Jun 22, 2005AB1RXNoNo► Subscribe► Subscribe► Subscribe
Wockhardt Ltd
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL201331-003Aug 30, 2012DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
TABLET;ORAL075491-002Apr 17, 2000ABRXNoNo► Subscribe► Subscribe► Subscribe
Orexigen
CONTRAVE
bupropion hydrochloride; naltrexone hydrochloride
TABLET, EXTENDED RELEASE;ORAL200063-001Sep 10, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Sandoz
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
TABLET;ORAL075613-002Oct 10, 2000DISCNNoNo► Subscribe► Subscribe► Subscribe
Invagen Pharms
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL206556-001Aug 26, 2016AB3RXNoNo► Subscribe► Subscribe► Subscribe
Anchen Pharms
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL077284-002Dec 14, 2006AB3RXNoNo► Subscribe► Subscribe► Subscribe
Jubilant Generics
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL202774-003Oct 11, 2013AB1RXNoNo► Subscribe► Subscribe► Subscribe
Invagen Pharms
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL206674-001Feb 9, 2016AB1RXNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
TABLET;ORAL076143-001Jan 17, 2006ABRXNoNo► 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
Glaxosmithkline
WELLBUTRIN
bupropion hydrochloride
TABLET;ORAL018644-002Dec 30, 1985► Subscribe► Subscribe
Glaxosmithkline
WELLBUTRIN SR
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL020358-004Jun 14, 2002► Subscribe► Subscribe
Glaxosmithkline
ZYBAN
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL020711-002May 14, 1997► Subscribe► Subscribe
Glaxosmithkline
WELLBUTRIN
bupropion hydrochloride
TABLET;ORAL018644-003Dec 30, 1985► Subscribe► Subscribe
Glaxosmithkline
WELLBUTRIN
bupropion hydrochloride
TABLET;ORAL018644-001Dec 30, 1985► Subscribe► Subscribe
Glaxosmithkline
WELLBUTRIN
bupropion hydrochloride
TABLET;ORAL018644-001Dec 30, 1985► Subscribe► Subscribe
Glaxosmithkline
WELLBUTRIN
bupropion hydrochloride
TABLET;ORAL018644-001Dec 30, 1985► Subscribe► Subscribe
Glaxosmithkline
WELLBUTRIN
bupropion hydrochloride
TABLET;ORAL018644-001Dec 30, 1985► Subscribe► Subscribe
Glaxosmithkline
ZYBAN
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL020711-002May 14, 1997► Subscribe► Subscribe
Glaxosmithkline
WELLBUTRIN SR
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL020358-001Oct 4, 1996► 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
6,143,327 Delayed release coated tablet of bupropion hydrochloride► Subscribe
8,703,191Controlled-release pharmaceutical tablets► 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:

Healthtrust
US Army
US Department of Justice
AstraZeneca
Dow
McKinsey
Harvard Business School
Fish and Richardson
Cipla
McKesson

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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