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Healthtrust
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Generated: November 16, 2018

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

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Supplementary Protection Certificates for safinamide mesylate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0752 Netherlands ➤ Sign Up PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224
C0054 France ➤ Sign Up PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224
782 Luxembourg ➤ Sign Up 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 ➤ Sign Up PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Julphar
Accenture
Medtronic
Citi
Merck
Healthtrust
QuintilesIMS
AstraZeneca

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