Safinamide mesylate - Generic Drug Details

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What are the generic sources for safinamide mesylate and what is the scope of freedom to operate?

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-four 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:	94
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	54
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)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
AC1MI4YU
AKOS015902297
ANW-58665
API0007783
BC256350
BCP16018
CHEMBL48582
CTK8B7807
D10191
EMD-1195686
EX-A2640
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
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

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Glossary

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

International Patents for safinamide mesylate

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Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	025326	Start Trial
Eurasian Patent Organization	017123	Start Trial
Luxembourg	92782	Start Trial
Lithuania	2474521	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for safinamide mesylate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613296	92782	Luxembourg	Start Trial	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
1613296	CR 2015 00042	Denmark	Start Trial	PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226
1613296	300752	Netherlands	Start Trial	PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224
1613296	15C0054	France	Start Trial	PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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