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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Drug Class	Aminoketone Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors Sigma-1 Receptor Agonists Uncompetitive NMDA Receptor Antagonists
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

Anatomical Therapeutic Chemical (ATC) Classes for bupropion hydrochloride; dextromethorphan hydrobromide

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

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

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Glossary

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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
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

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Country	Patent Number	Title	Estimated Expiration
Japan	2022516361	うつ病の治療のためのデキストロメトルファンおよびブプロピオンの組み合わせ	⤷ Sign Up
South Korea	20210110654	우울증 치료를 위한 덱스트로메토르판과 부프로피온의 조합	⤷ Sign Up
New Zealand	719892	Compositions and methods comprising bupropion or related compounds and dextromethorphan	⤷ Sign Up
Peru	20211752	FORMAS Y METODOS DE DOSIS PARA BUPROPION ENANTIOMERICAMENTE ENRIQUECIDO O PURO	⤷ Sign Up
Singapore	11201704066V	METHODS OF MODULATING DRUG PLASMA LEVELS USING ERYTHROHYDROXYBUPROPION	⤷ Sign Up
Costa Rica	20220119	FORMAS DE DOSIFICACIÓN PARA BUPROPIÓN ENANTIOMÉRICAMENTE ENRIQUECIDO O PURO (DOSAGE FORMS AND METHODS FOR ENANTIOMERICALLY ENRICHED OR PURE BUPROPION)	⤷ Sign Up
Malaysia	179696	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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2316456	1790064-8	Sweden	⤷ 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; REG. NO/DATE: 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	122017000109	Germany	⤷ Sign Up	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	2017C/064	Belgium	⤷ Sign Up	PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
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
0656775	CR 2000 00018	Denmark	⤷ Sign Up	PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
2316456	132017000142109	Italy	⤷ Sign Up	PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): 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.