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Bupropion hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for bupropion hydrochloride?

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, Sciegen Pharms Inc, Mylan, Wockhardt Ltd, Apotex Inc, Watson Labs Inc, Invagen Pharms, Sun Pharma Global, Zydus Pharms Usa Inc, Torrent Pharms Ltd, Jubilant Generics, Sandoz Inc, Heritage Pharma, Alvogen, and Orexigen, and is included in forty-four NDAs. There are twelve patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has one patent family member in one country.

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

Summary for Generic Name: bupropion hydrochloride

Tradenames:7
Patents:13
Applicants:22
NDAs:44
Drug Master File Entries: see list36
Suppliers / Packagers: see list72
Bulk Api Vendors: see list79
Clinical Trials: see list1,098
Patent Applications: see list728
Therapeutic Class:Antidepressants
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline
WELLBUTRIN
bupropion hydrochloride
TABLET;ORAL018644-001Dec 30, 1985DISCNNoNo► Subscribe► Subscribe
Invagen Pharms
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL206674-003Feb 9, 2016RXNoNo► Subscribe► Subscribe
Actavis Labs Fl Inc
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL079095-003Mar 24, 2009RXNoNo► Subscribe► Subscribe
Zydus Pharms Usa Inc
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL201567-001Jan 17, 2014RXNoNo► Subscribe► Subscribe
Jubilant Generics
BUPROPION HYDROCHLORIDE
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL202775-001Oct 11, 2013RXNoNo► 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;ORAL018644-001Dec 30, 19854,347,257► Subscribe
Glaxosmithkline
WELLBUTRIN
bupropion hydrochloride
TABLET;ORAL018644-002Dec 30, 19854,347,257► Subscribe
Glaxosmithkline
WELLBUTRIN SR
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL020358-002Oct 4, 19965,731,000► Subscribe
Glaxosmithkline
ZYBAN
bupropion hydrochloride
TABLET, EXTENDED RELEASE;ORAL020711-002May 14, 19975,763,493► Subscribe
Glaxosmithkline
WELLBUTRIN
bupropion hydrochloride
TABLET;ORAL018644-001Dec 30, 19854,425,363► 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
C/GB00/019United Kingdom► SubscribePRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
/2000Austria► SubscribePRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
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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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