BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE - Generic Drug Details
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What are the generic drug 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 fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Bupropion hydrochloride; dextromethorphan hydrobromide has one hundred and eighty-two patent family members in thirty-one countries.
One supplier is listed for this compound.
Summary for BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
International Patents: | 182 |
US Patents: | 115 |
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
Sponsor | Phase |
---|---|
Medical University of South Carolina | Phase 1 |
See all BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE clinical trials
Pharmacology 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Axsome | AUVELITY | bupropion hydrochloride; dextromethorphan hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 215430-001 | Aug 18, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Axsome | AUVELITY | bupropion hydrochloride; dextromethorphan hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 215430-001 | Aug 18, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Axsome | AUVELITY | bupropion hydrochloride; dextromethorphan hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 215430-001 | Aug 18, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 |
---|---|---|---|
European Patent Office | 4255433 | BUPROPION ET DEXTROMÉTHORPHANE POUR LA RÉDUCTION DU RISQUE DE SUICIDE CHEZ DES PATIENTS DÉPRESSIFS (BUPROPION AND DEXTROMETHROPHAN FOR REDUCTION OF SUICIDE RISK IN DEPRESSION PATIENTS) | ⤷ Try a Trial |
Serbia | 61113 | BUPROPION ZA MODULACIJU NIVOA LEKA DEKSTROMETORFANA U PLAZMI (BUPROPION FOR MODULATING DRUG PLASMA LEVELS OF DEXTROMETORPHAN) | ⤷ Try a Trial |
Brazil | 112022005045 | FORMA DE DOSAGEM, USO E KIT DE (S)-BUPROPIONA QUE É PELO MENOS 95% ENANTIOMERICAMENTE PURA | ⤷ Try a Trial |
Israel | 276871 | צורות מינון של בופרופיון טהור ושיטות למטרות עיוות אננטריומרית (Dosage forms and methods for enantiomerically enriched or pure bupropion) | ⤷ Try a Trial |
>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 | LUC00054 | Luxembourg | ⤷ Try a 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; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330 |
2316456 | 2017/059 | Ireland | ⤷ Try a 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; REGISTRATION NO/DATE: EU/1/14/988 20150326 |
2316456 | 122017000109 | Germany | ⤷ Try a Trial | 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 | 1790064-8 | Sweden | ⤷ Try a 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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