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 sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Bupropion hydrochloride; dextromethorphan hydrobromide has one hundred and eighty-four patent family members in thirty-one countries.
One supplier is listed for this compound.
Summary for BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
International Patents: | 184 |
US Patents: | 116 |
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 | ⤷ 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 | ||||
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 | ||||
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 |
---|---|---|---|
Japan | 2020023543 | ブプロピオンまたは関連組成物およびデキストロメトルファンを含む組成物および方法 (METHODS AND COMPOSITIONS COMPRISING BUPROPION OR RELATED COMPOUNDS AND DEXTROMETHORPHAN) | ⤷ Sign Up |
Chile | 2021001810 | Combinación de dextrometorfano y bupropión para el tratamiento de depresión | ⤷ Sign Up |
South Korea | 20220038820 | 에리트로히드록시부프로피온을 이용한 약물의 혈장 농도의 조절 방법 (METHODS OF MODULATING DRUG PLASMA LEVELS USING ERYTHROHYDROXYBUPROPION) | ⤷ Sign Up |
New Zealand | 764077 | Compositions and methods comprising bupropion or related compounds for sustained delivery of dextromethorphan | ⤷ Sign Up |
Brazil | 112022005045 | FORMA DE DOSAGEM, USO E KIT DE (S)-BUPROPIONA QUE É PELO MENOS 95% ENANTIOMERICAMENTE PURA | ⤷ 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 | CA 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 |
2316456 | SPC/GB17/078 | United Kingdom | ⤷ 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.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330 |
2316456 | LUC00054 | Luxembourg | ⤷ 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; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330 |
2316456 | 300918 | Netherlands | ⤷ Sign Up | PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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