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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 Us Worldmeds Llc 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.

Summary for safinamide mesylate

International Patents:	97
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Bulk Api Vendors:	55
Patent Applications:	24
DailyMed Link:	safinamide mesylate at DailyMed

Synonyms for safinamide mesylate

(S)-( )-2-(4-(3-Fluorobenzyloxy) benzylamino)propanamide, methanesulfonate

(S)-2-((4-((3-Fluorobenzyl)oxy)benzyl)-amino)propanamide methanesulfonate

(S)-2-((4-((3-Fluorobenzyl)oxy)benzyl)amino)propanamide methanesulfonate

(S)-2-((4-((3-fluorobenzyl)oxy)benzyl)amino)propanamidemethanesulfonate

(S)-2-[[4-[(3-fluorobenzyl)oxy]benzyl]amino]propanamide methanesulfonate

(S)-2-[4-(3-Fluorobenzyloxy)benzylamino]propanamide methanesulfonate

(S)-2[4-(3-fluorobenzyloxy)benzylamino]propanamide methanesulfonate

0395AB

202825-46-5

AC-27739

AKOS015902297

ANW-58665

API0007783

BCP16018

CHEMBL48582

CTK8B7807

D10191

EMD 1195686 mesylate

EMD-1195686

EX-A2640

FCE-28073

FCE-28073, PNU-151774E, NW-1015, 202825-46-5

FCE-28073(R-isomer)

FT-0697967

J-013174

KS-000002KO

MLS006010740

NW 1015

NW-1015

PNU 151774E

PNU-151774E

PNU-151774E,FCE28073

Propanamide, 2-(((4-((3-fluorophenyl)methoxy)phenyl)methyl)amino)-, (S)-, monomethanesulfonate

Propanamide, 2-[[[4-[(3-fluorophenyl)methoxy]phenyl]methyl]amino]-, (2S)-, methanesulfonate (1:1)

Q27294690

R-isomer

s1472

Safinamide mesilate

Safinamide mesilate (JAN)

Safinamide Mesylate (FCE28073)

Safinamide mesylate (USAN)

Safinamide mesylate [USAN]

Safinamide mesylate salt

Safinamide mesylate salt, >=98% (HPLC)

safinamide methanesulfonate

SB16692

SC-96756

SCHEMBL1665715

SMR004701699

ST24035821

SW219452-1

TC-147410

UNII-YS90V3DTX0

Xadago (TN)

YKOCHIUQOBQIAC-YDALLXLXSA-N

YS90V3DTX0

Z-3267

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
Us Worldmeds Llc	XADAGO	safinamide mesylate	TABLET;ORAL	207145-002	Mar 21, 2017		RX	Yes	Yes				Y
Us Worldmeds Llc	XADAGO	safinamide mesylate	TABLET;ORAL	207145-002	Mar 21, 2017		RX	Yes	Yes
Us Worldmeds Llc	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017		RX	Yes	No
Us Worldmeds Llc	XADAGO	safinamide mesylate	TABLET;ORAL	207145-002	Mar 21, 2017		RX	Yes	Yes			Y	Y
Us Worldmeds Llc	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017		RX	Yes	No				Y

International Patents for safinamide mesylate

Country	Patent Number	Estimated Expiration
Norway	334316
Denmark	2070526
Cyprus	1118113
Luxembourg	92782
South Korea	20060010745

Supplementary Protection Certificates for safinamide mesylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	46/2015	Austria		PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224
1613296	132016000023012	Italy		PRODUCT NAME: SAFINAMIDE(XADAGO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/984, 20150224
1613296	122015000058	Germany		PRODUCT NAME: XADAGO; REGISTRATION NO/DATE: EU/1/14/984 20150224
1613296	241 50017-2015	Slovakia		PRODUCT NAME: SAFINAMID; REGISTRATION NO/DATE: EU/1/14/984/001 - EU/1/14/984/010 20150226