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Last Updated: November 2, 2024

Bupropion hydrobromide - Generic Drug Details


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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-two patent family members in eighteen countries.

There are five 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:52
US Patents:8
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 5
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 20
Clinical Trials: 3
What excipients (inactive ingredients) are in bupropion hydrobromide?bupropion hydrobromide excipients list
DailyMed Link:bupropion hydrobromide at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for bupropion hydrobromide
Generic Entry Date for bupropion hydrobromide*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for bupropion hydrobromide

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

SponsorPhase
Bausch Health Americas, Inc.Phase 4
Valeant Pharmaceuticals International, Inc.Phase 4
Alphacait, LLCPhase 2

See all bupropion hydrobromide clinical trials

Generic filers with tentative approvals for BUPROPION HYDROBROMIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up522MGTABLET, EXTENDED RELEASE; ORAL
⤷  Sign Up⤷  Sign Up174MGTABLET, 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
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 022108-002 Apr 23, 2008 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-002 Apr 23, 2008 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bausch APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 2017/059 Ireland ⤷  Sign Up 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 132017000142109 Italy ⤷  Sign Up PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
2316456 CR 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 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.