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Last Updated: November 2, 2024

Bupropion hydrochloride; dextromethorphan hydrobromide - Generic Drug Details


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

Bupropion hydrochloride; dextromethorphan hydrobromide is the generic ingredient in one branded drug marketed by Axsome and is included in one NDA. There are one hundred and nineteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Bupropion hydrochloride; dextromethorphan hydrobromide has one hundred and ninety-four patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for bupropion hydrochloride; dextromethorphan hydrobromide
International Patents:194
US Patents:119
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 1
DailyMed Link:bupropion hydrochloride; dextromethorphan hydrobromide at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for bupropion hydrochloride; dextromethorphan hydrobromide
Generic Entry Date for bupropion hydrochloride; dextromethorphan 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 hydrochloride; dextromethorphan hydrobromide

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

SponsorPhase
Medical University of South CarolinaPhase 1

See all bupropion hydrochloride; dextromethorphan hydrobromide clinical trials

Paragraph IV (Patent) Challenges for BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AUVELITY Extended-release Tablet bupropion hydrochloride; dextromethorphan hydrobromide 45 mg/105 mg 215430 1 2022-12-22

US Patents and Regulatory Information for bupropion hydrochloride; dextromethorphan hydrobromide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Axsome AUVELITY bupropion hydrochloride; dextromethorphan hydrobromide TABLET, EXTENDED RELEASE;ORAL 215430-001 Aug 18, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Axsome AUVELITY bupropion hydrochloride; dextromethorphan hydrobromide TABLET, EXTENDED RELEASE;ORAL 215430-001 Aug 18, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Axsome AUVELITY bupropion hydrochloride; dextromethorphan hydrobromide TABLET, EXTENDED RELEASE;ORAL 215430-001 Aug 18, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Axsome AUVELITY bupropion hydrochloride; dextromethorphan hydrobromide TABLET, EXTENDED RELEASE;ORAL 215430-001 Aug 18, 2022 RX Yes Yes ⤷  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

International Patents for bupropion hydrochloride; dextromethorphan hydrobromide

Country Patent Number Title Estimated Expiration
Nicaragua 202000056 FORMAS Y MÉTODOS DE DOSIS PARA BUPROPIÓN ENANTIOMÉRICAMENTE ENRIQUECIDO O PURO ⤷  Sign Up
New Zealand 764088 Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan ⤷  Sign Up
Singapore 11201603391X COMPOSITIONS AND METHODS COMPRISING BUPROPION OR RELATED COMPOUNDS AND DEXTROMETHORPHAN ⤷  Sign Up
Mexico 2021015234 COMPOSICIONES Y METODOS QUE COMPRENDEN BUPROPION O COMPUESTOS RELACIONADOS Y DEXTROMETORFANO. (COMPOSITIONS AND METHODS COMPRISING BUPROPION OR RELATED COMPOUNDS AND DEXTROMETHORPHAN.) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for bupropion hydrochloride; dextromethorphan 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
2316456 C201730057 Spain ⤷  Sign Up 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
>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.