BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE - Generic Drug Details
✉ Email this page to a colleague
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 twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.Bupropion hydrochloride; dextromethorphan hydrobromide has one hundred and ninety-five patent family members in thirty-two countries.
One supplier is listed for this compound.
Summary for BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
International Patents: | 195 |
US Patents: | 120 |
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 | 11,207,281 | ⤷ Subscribe | ⤷ Subscribe | ||||
Axsome | AUVELITY | bupropion hydrochloride; dextromethorphan hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 215430-001 | Aug 18, 2022 | RX | Yes | Yes | 10,105,361 | ⤷ Subscribe | ⤷ Subscribe | ||||
Axsome | AUVELITY | bupropion hydrochloride; dextromethorphan hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 215430-001 | Aug 18, 2022 | RX | Yes | Yes | 11,382,874 | ⤷ Subscribe | ⤷ Subscribe | ||||
Axsome | AUVELITY | bupropion hydrochloride; dextromethorphan hydrobromide | TABLET, EXTENDED RELEASE;ORAL | 215430-001 | Aug 18, 2022 | RX | Yes | Yes | 11,541,048 | ⤷ Subscribe | ⤷ Subscribe | ||||
>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 | 3908270 | ⤷ Subscribe | |
China | 113797205 | 包含安非他酮或相关化合物和右美沙芬的组合物和方法 (COMPOSITIONS AND METHODS COMPRISING BUPROPION OR RELATED COMPOUNDS AND DEXTROMETHORPHAN) | ⤷ Subscribe |
China | 106163522 | 包含安非他酮或相关化合物和右美沙芬的组合物和方法 (Compositions and methods comprising bupropion or related compounds and dextromethorphan) | ⤷ Subscribe |
European Patent Office | 4373480 | TRAITEMENT DE LA DÉPRESSION (TREATMENT OF DEPRESSION) | ⤷ Subscribe |
>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 | 122017000109 | Germany | ⤷ Subscribe | 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 | 17C1058 | France | ⤷ Subscribe | PRODUCT NAME: NALTREXONE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE NALTREXONE ET,BUPROPION OU SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER CHLORHYDRATE DE BUPROPION; REGISTRATION NO/DATE: EU/1/14/988 20150330 |
2316456 | 2017/059 | Ireland | ⤷ Subscribe | 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 | CA 2017 00062 | Denmark | ⤷ Subscribe | 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 |
BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE Market Analysis and Financial Projection Experimental
More… ↓
Make Better Decisions: Try a trial or see plans & pricing
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.