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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 safinamide mesylate 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.

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

Summary for safinamide mesylate

US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	46
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

Synonyms for safinamide mesylate

(2S)-2-[[4-[(3-fluorophenyl)methoxy]phenyl]methylamino]propanamide; methanesulfonic acid

(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]propanamide methanesulfonate

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

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

0395AB

202825-46-5

AC-27739

AC1MI4YU

AK-77848

AKOS015902297

ANW-58665

API0007783

BC256350

CHEMBL48582

CTK8B7807

D10191

FCE-28073

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

FCE-28073(R-isomer)

FT-0697967

I14-13727

J-013174

KB-210863

KS-000002KO

MLS006010740

MolPort-009-679-479

NW 1015

NW-1015

PNU 151774E

PNU-151774E

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

s1472

Safinamide mesilate

Safinamide Mesylate (FCE28073)

Safinamide mesylate (USAN)

Safinamide mesylate [USAN]

Safinamide mesylate salt, >=98% (HPLC)

safinamide methanesulfonate

SC-96756

SCHEMBL1665715

SMR004701699

ST24035821

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

International Patents for safinamide mesylate

Country	Document Number	Estimated Expiration
Lithuania	2474521
New Zealand	595737
Norway	2015018
Poland	2474521

Supplementary Protection Certificates for safinamide mesylate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0752	Netherlands		PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224
C0054	France		PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224
782	Luxembourg		PRODUCT NAME: SAFINAMIDE A UTILISER EN COMBINAISON AVEC LEVODOPA/PDI, ET EVENTUELLEMENT AVEC D'AUTRES MEDICAMENTS PD , POUR LE TRAITEMENT DE LA MALADIE DE PARKINSON; FIRST REGISTRATION DATE: 20150224
2015 00042	Denmark		PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226