AXSOME Company Profile

What is the competitive landscape for AXSOME, and when can generic versions of AXSOME drugs launch?

AXSOME has two approved drugs.

There are one hundred and forty-four US patents protecting AXSOME drugs.

There are two hundred and thirty-eight patent family members on AXSOME drugs in thirty-seven countries and thirty-one supplementary protection certificates in fifteen countries.

Summary for AXSOME

International Patents:	238
US Patents:	144
Tradenames:	2
Ingredients:	2
NDAs:	2

Drugs and US Patents for AXSOME

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes	11,839,598
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes	9,408,815
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019		RX	Yes	No	9,604,917
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes	11,020,389
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019		RX	Yes	No	11,779,554
Axsome	AUVELITY	bupropion hydrochloride; dextromethorphan hydrobromide	TABLET, EXTENDED RELEASE;ORAL	215430-001	Aug 18, 2022		RX	Yes	Yes	11,285,146
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes	11,857,528

International Patents for AXSOME Drugs

Country	Patent Number	Estimated Expiration
Mexico	2021008247
China	111201014
Japan	2020023527
China	110251517
Japan	2023519965
Russian Federation	2008100019
China	112087999

Supplementary Protection Certificates for AXSOME Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1890684	2090011-4	Sweden		PRODUCT NAME: SOLRIAMFETOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF, PREFERABLY A HYDROCHLORIDE SALT THEROF; REG. NO/DATE: EU/1/19/1408 20200120
1890684	SPC/GB20/017	United Kingdom		PRODUCT NAME: SOLRIAMFETOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY A HYDROCHLORIDE SALT THEREOF; REGISTERED: UK EU/1/19/1408 (NI) 20200120; UK PLGB 31626/0003 20200120; UK PLGB 31626/0002 20200120
2316456	349 22-2017	Slovakia		PRODUCT NAME: KOMBINACIA NALTREXONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM A BUPROPIONU VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/988 20150330
2316456	1790064-8	Sweden		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
1890684	C202030015	Spain		PRODUCT NAME: SOLRIAMFETOL O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, PREFERIBLEMENTE UNA SAL DE CLORHIDRATO DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/19/1408; DATE OF AUTHORISATION: 20200116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1408; DATE OF FIRST AUTHORISATION IN EEA: 20200116
1890684	CR 2020 00016	Denmark		PRODUCT NAME: SOLRIAMFETOL ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, FORTRINSVIS ET HYDROCHLORIDSALT DERAF; REG. NO/DATE: EU/1/19/1408 20200120
2316456	C201730057	Spain		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

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Axsome
• Axsome Malta