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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Cerilliant
Queensland Health
Teva
Farmers Insurance
Deloitte
Express Scripts
Medtronic
Baxter

Generated: April 26, 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-six 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
Sandoz BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 075932-002 Mar 22, 2004 AB1 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Invagen Pharms BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 206556-001 Aug 26, 2016 AB3 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
Heritage Pharma BUPROPION HYDROCHLORIDE bupropion hydrochloride TABLET;ORAL 206975-001 Aug 19, 2016 AB 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 WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-002 Dec 30, 1985 ➤ Sign Up ➤ Sign Up
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-003 Dec 30, 1985 ➤ Sign Up ➤ Sign Up
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-001 Dec 30, 1985 ➤ 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
0918 Netherlands ➤ Sign Up PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330
/2000 Austria ➤ Sign Up PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2017000109 Germany ➤ Sign Up PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 20150326
2017 00062 Denmark ➤ Sign Up PRODUCT NAME: NALTREXON ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NALTREXONHYDROCHLORID, OG BUPROPION ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BUPROPIONHYDROCHLORID; REG. NO/DATE: EU/1/14/988 20150330
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Fish and Richardson
Chubb
Chinese Patent Office
Federal Trade Commission
Merck
Covington
Cantor Fitzgerald
Julphar

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