Axsome Malta Company Profile

What is the competitive landscape for AXSOME MALTA, and what generic alternatives to AXSOME MALTA drugs are available?

AXSOME MALTA has one approved drug.

There are nine US patents protecting AXSOME MALTA drugs.

There are forty patent family members on AXSOME MALTA drugs in nineteen countries and eleven supplementary protection certificates in ten countries.

Summary for Axsome Malta

International Patents:	40
US Patents:	9
Tradenames:	1
Ingredients:	1
NDAs:	1

Drugs and US Patents for Axsome Malta

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	211230-001	Jun 17, 2019		RX	Yes	No	8,440,715
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes	9,604,917
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019		RX	Yes	No	10,512,609
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-002	Jun 17, 2019		RX	Yes	Yes
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019		RX	Yes	No	10,195,151		Y
Axsome Malta	SUNOSI	solriamfetol hydrochloride	TABLET;ORAL	211230-001	Jun 17, 2019		RX	Yes	No	10,912,754

International Patents for Axsome Malta Drugs

Country	Patent Number	Estimated Expiration
Australia	2006254899
European Patent Office	3509581
Canada	2611713
Spain	2435403
Australia	2017324855
European Patent Office	3630072

Supplementary Protection Certificates for Axsome Malta Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	301037	Netherlands		PRODUCT NAME: SOLRIAMFETOL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, BIJ VOORKEUR HET HYDROCHLORIDEZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1408 20200120
1890684	122020000015	Germany		PRODUCT NAME: SOLRIAMFETOL ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON, BEVORZUGT EIN HYDROCHLORIDSALZ DAVON.; REGISTRATION NO/DATE: EU/1/19/1408 20200116
1890684	132020000000040	Italy		PRODUCT NAME: SOLRIAMFETOL O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE, PREFERIBILMENTE UN SUO SALE CLORIDRATO(SUNOSI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1408, 20200120
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

Similar Applicant Names

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

• Axsome Malta