Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Moodys
Colorcon
Baxter
McKesson
McKinsey
Johnson and Johnson

Last Updated: May 24, 2022

Bupropion hydrobromide - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

What are the generic sources for bupropion hydrobromide and what is the scope of patent protection?

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 five drug master file entries for bupropion hydrobromide. One supplier is listed for this compound.

Summary for bupropion hydrobromide
International Patents:53
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 5
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 18
Clinical Trials: 3
Patent Applications: 7,419
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
Valeant Pharmaceuticals International, Inc.Phase 4
Bausch Health Americas, Inc.Phase 4
Haining Health-Coming Biotech Co., Ltd.Phase 2

See all bupropion hydrobromide clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for bupropion hydrobromide
Paragraph IV (Patent) Challenges for BUPROPION HYDROBROMIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
APLENZIN Extended-release Tablets bupropion hydrobromide 522 mg 022108 1 2009-12-24
APLENZIN Extended-release Tablets bupropion hydrobromide 174 mg 022108 1 2009-09-28
APLENZIN Extended-release Tablets bupropion hydrobromide 348 mg 022108 1 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 022108-003 Apr 23, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-001 Apr 23, 2008 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-001 Apr 23, 2008 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-002 Apr 23, 2008 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for bupropion hydrobromide

Country Patent Number Title Estimated Expiration
Russian Federation 2010107843 БУПРОПИОНА ГИДРОБРОМИД И ЕГО ТЕРАПЕВТИЧЕСКИЕ ПРИМЕНЕНИЯ See Plans and Pricing
Ecuador SP109923 BROMHIDRATO DE BUPROPION Y APLICACIONES TERAPÉUTICAS See Plans and Pricing
Singapore 183695 BUPROPION HYDROBROMIDE AND THERAPEUTIC APPLICATIONS See Plans and Pricing
Canada 2655596 SYSTEME DE DELIVRANCE OSMOTIQUE MULTIPARTICULAIRE (MULTIPARTICULATE OSMOTIC DELIVERY SYSTEM) See Plans and Pricing
Nicaragua 201000015 BROMHIDRATO DE BUPROPIÓN Y APLICACIONES TERAPÉUTICAS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for bupropion hydrobromide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2316456 2017C/064 Belgium See Plans and Pricing PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
2316456 122017000109 Germany See Plans and Pricing 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
2316456 C201730057 Spain See Plans and Pricing 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 2017/059 Ireland See Plans and Pricing 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; REGISTRATION NO/DATE: EU/1/14/988 20150326
2316456 349 22-2017 Slovakia See Plans and Pricing PRODUCT NAME: KOMBINACIA NALTREXONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM A BUPROPIONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/988 20150330
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Express Scripts
AstraZeneca
McKinsey
Johnson and Johnson

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 verification 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.