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Safinamide mesylate - Generic Drug Details

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What are the generic drug sources for safinamide mesylate and what is the scope of patent protection?

Safinamide mesylate is the generic ingredient in one branded drug marketed by Mdd Us and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Safinamide mesylate has ninety-seven patent family members in thirty-one countries.

There are two drug master file entries for safinamide mesylate. One supplier is listed for this compound.

Summary for safinamide mesylate

International Patents:	97
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	61
Patent Applications:	24
DailyMed Link:	safinamide mesylate at DailyMed

Pharmacology for safinamide mesylate

Drug Class	Monoamine Oxidase Type B Inhibitor
Mechanism of Action	Monoamine Oxidase-B Inhibitors Breast Cancer Resistance Protein Inhibitors

US Patents and Regulatory Information for safinamide mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017		RX	Yes	No
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017		RX	Yes	No			Y	Y
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-002	Mar 21, 2017		RX	Yes	Yes
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017		RX	Yes	No				Y
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017		RX	Yes	No

International Patents for safinamide mesylate

Country	Patent Number	Estimated Expiration
South Korea	20140027563
Spain	2326373
Slovenia	1613296
Norway	20090231
Slovenia	2070526

Supplementary Protection Certificates for safinamide mesylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613296	241 50017-2015	Slovakia		PRODUCT NAME: SAFINAMID; REGISTRATION NO/DATE: EU/1/14/984/001 - EU/1/14/984/010 20150226
1613296	132016000023012	Italy		PRODUCT NAME: SAFINAMIDE(XADAGO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/984, 20150224
1613296	C 2015 034	Romania		PRODUCT NAME: SAFINAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/14/984; DATE OF NATIONAL AUTHORISATION: 20150224; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/984; DATE OF FIRST AUTHORISATION IN EEA: 20150224
1613296	CA 2015 00042	Denmark		PRODUCT NAME: KOMBINATION AF SAFINAMID OG LEVOPODA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150224
1613296	C20150033 00258	Estonia		PRODUCT NAME: SAFINAMIID;REG NO/DATE: EU/1/14/984 26.02.2015