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Last Updated: October 28, 2021

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BUPROPION HYDROBROMIDE - Generic Drug Details

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What are the generic drug sources for bupropion hydrobromide and what is the scope of freedom to operate?

Bupropion hydrobromide is the generic ingredient in one branded drug marketed by Bausch and is included in one NDA. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bupropion hydrobromide has fifty-three patent family members in eighteen countries.

There are thirty-eight drug master file entries for bupropion hydrobromide. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for BUPROPION HYDROBROMIDE
International Patents:53
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 38
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 16
Clinical Trials: 3
Patent Applications: 79
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in BUPROPION HYDROBROMIDE?BUPROPION HYDROBROMIDE excipients list
DailyMed Link:BUPROPION HYDROBROMIDE at DailyMed
Recent Clinical Trials for BUPROPION HYDROBROMIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Haining Health-Coming Biotech Co., Ltd.Phase 2
Medical University of South CarolinaPhase 1
Valeant Pharmaceuticals International, Inc.Phase 4

See all BUPROPION HYDROBROMIDE clinical trials

Generic filers with tentative approvals for BUPROPION HYDROBROMIDE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial522MGTABLET, EXTENDED RELEASE; ORAL
⤷  Free Forever Trial⤷  Free Forever Trial174MGTABLET, EXTENDED RELEASE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for BUPROPION HYDROBROMIDE
Paragraph IV (Patent) Challenges for BUPROPION HYDROBROMIDE
Tradename Dosage Ingredient NDA Submissiondate
APLENZIN TABLET, EXTENDED RELEASE;ORAL bupropion hydrobromide 022108 2009-12-24
APLENZIN TABLET, EXTENDED RELEASE;ORAL bupropion hydrobromide 022108 2009-09-28
APLENZIN TABLET, EXTENDED RELEASE;ORAL bupropion hydrobromide 022108 2009-09-24

US Patents and Regulatory Information for BUPROPION HYDROBROMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-002 Apr 23, 2008 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for BUPROPION HYDROBROMIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 17C1058 France ⤷  Free Forever Trial PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330
0467488 SPC/GB00/019 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
2316456 C 2017 047 Romania ⤷  Free Forever Trial PRODUCT NAME: COMBINATIE DE NALTREXONA SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTEIA, IN PARTICULAR CLORHIDRAT DE NALTREXONA SI BUPROPION SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA, IN PARTICULAR CLORHIDRAT DE BUPROPION; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF NATIONAL AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
0656775 28/2000 Austria ⤷  Free Forever Trial PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Baxter
Moodys
Mallinckrodt
Harvard Business School

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