Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 15, 2019

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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 patent protection?

Bupropion hydrobromide is the generic ingredient in one branded drug marketed by Valeant Pharms North 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-one patent family members in seventeen 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.

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

Recent Litigation for bupropion hydrobromide

Identify potential future generic entrants

District Court Litigation
Case NameDate
Valeant International (Barbados) SRL v. Paddock Laboratories, Inc.2010-04-15
Valeant International, Bermuda v. Watson Pharmaceuticals Inc.2010-02-19
Biovail Laboratories International SRL v. Watson Pharmaceuticals Inc.2010-02-18

See all bupropion hydrobromide litigation

Generic filers with tentative approvals for BUPROPION HYDROBROMIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial522MGTABLET, EXTENDED RELEASE; ORAL
  Start Trial  Start 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
Synonyms for bupropion hydrobromide
2-(tert-Butylamino)-1-(3-chlorophenyl)propan-1-one hydrobromide
2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one,hydrobromide
905818-69-1
AKOS015917698
Aplenzin
Aplenzin (TN)
Aplenzin ER
bupropion HBr
Bupropion hydrobromide (USAN)
Bupropion hydrobromide [USAN]
CHEMBL1201735
D07938
I14-9201
SCHEMBL636116
WSTCENNATOVXKQ-UHFFFAOYSA-N
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
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-002 Apr 23, 2008 RX Yes No   Start Trial   Start Trial Y   Start Trial
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-002 Apr 23, 2008 RX Yes No   Start Trial   Start Trial Y   Start Trial
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes   Start Trial   Start Trial   Start Trial
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-002 Apr 23, 2008 RX Yes No   Start Trial   Start Trial Y   Start Trial
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-001 Apr 23, 2008 RX Yes No   Start Trial   Start Trial   Start Trial
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-001 Apr 23, 2008 RX Yes No   Start Trial   Start Trial Y   Start 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   Start 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
2316456 C 2017 047 Romania   Start 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
2316456 C201730057 Spain   Start Trial PRODUCT NAME: NALTREXONA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DE LA MISMA, EN PARTICULAR CLORHIDRATO DE NALTREXONA, Y BUPROPION O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR CLORHIDRATO DE BUPROPION.; NATIONAL AUTHORISATION NUMBER: EU/1/14/988; DATE OF AUTHORISATION: 20150326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/988; DATE OF FIRST AUTHORISATION IN EEA: 20150326
2316456 2017C/064 Belgium   Start Trial PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
0467488 SPC/GB00/019 United Kingdom   Start Trial PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
2316456 1790064-8 Sweden   Start Trial PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; REG. NO/DATE: EU/1/14/988 20150330
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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