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Last Updated: March 30, 2020

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

Supplementary Protection Certificates for safinamide mesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1613296 C 2015 034 Romania   Start Trial 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   Start Trial PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224
1613296 132016000023012 Italy   Start Trial PRODUCT NAME: SAFINAMIDE(XADAGO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/984, 20150224
1613296 122015000058 Germany   Start Trial PRODUCT NAME: XADAGO; REGISTRATION NO/DATE: EU/1/14/984 20150224
1613296 241 50017-2015 Slovakia   Start Trial PRODUCT NAME: SAFINAMID; REGISTRATION NO/DATE: EU/1/14/984/001 - EU/1/14/984/010 20150226
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
McKesson
Medtronic
Boehringer Ingelheim
Johnson and Johnson
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.