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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Queensland Health
Fuji
Dow
Harvard Business School
Cantor Fitzgerald
Julphar
Daiichi Sankyo
Fish and Richardson

Generated: February 17, 2019

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XADAGO Drug Profile

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When do Xadago patents expire, and what generic alternatives are available?

Xadago is a drug marketed by Us Worldmeds Llc and is included in one NDA. There are three patents protecting this drug.

This drug has ninety patent family members in thirty-one countries.

The generic ingredient in XADAGO is safinamide mesylate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the safinamide mesylate profile page.

Summary for XADAGO
Drug patent expirations by year for XADAGO
Generic Entry Opportunity Date for XADAGO
Generic Entry Date for XADAGO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Synonyms for XADAGO
(+-)-(S)-2-((p-((m-Fluorobenzyl)oxy)benzyl)amino)propionamide
(2''S'')-2-[[4-[(3-Fluorophenyl)methoxy]phenyl] methylamino]propanamide
(2S)-2-[({4-[(3-fluorophenyl)methoxy]phenyl}methyl)amino]propanamide
(2S)-2-[[4-[(3-Fluorophenyl)methoxy]phenyl]methylamino]propanamide
(5)-2-[4-(3-fluorobenzyloxy)benzylamino]propanamide
(S)-(+)-2-[4-(3-FLUOROBENZYLOXY)BENZYLAMINO]PROPANAMIDE METHANSULFONATE
(S)-2-(((4-((3-Fluorophenyl)methoxy)phenyl)methyl)amino)propanamide
(S)-2-((4-((3-Fluorobenzyl)oxy)benzyl)amino)propanamide
(S)-2-[[4-[(3-Fluorobenzyl)oxy]benzyl]amino]propionamide
(S)-2-[4-(3-Fluoro-benzyloxy)-benzylamino]-propionamide; compound with methanesulfonic acid
(S)-2-[4-(3-fluorobenzyloxy)benzylamino]propanamide
(S)-2[4-(3-fluorobenzyloxy)benzylamino] propanamide
(S)-2[4-(3-fluorobenzyloxy)benzylamino]propanamide
133865-89-1
2-(4-(3-Fluorobenzyloxy)benzylamino)propionamide
2(s)-(4-(3-fluorobenzyloxy)benzylamino)propionamide
6135AA
90ENL74SIG
AC-26829
AC1L2ZLK
AJ-112157
AK-77847
AKOS016002015
ANW-58666
API0009223
AX8150732
BC224413
BDBM19187
BDBM50078694
CHEBI:134718
CHEMBL396778
CHEMBL48582
CS-0556
CTK8B7808
D02MOK
D0TV6I
D10158
DB06654
EC 603-772-2
EMD 1195686
EMD-1195686
Fce 26743
Fce-26743
FT-0700949
GTPL8291
HY-70057
J-506604
M6252
MolPort-005-942-375
N2-(4-((3-Fluorbenzyl)oxy)benzyl)-L-alaninamid
N2-{4-[(3-fluorobenzyl)oxy]benzyl}-L-alaninamide
NCGC00346529-01
NEMGRZFTLSKBAP-LBPRGKRZSA-N
ON 019190.Na
P111001
Propanamide, 2-(((4-((3-fluorophenyl)methoxy)phenyl)methyl)amino)-, (S)-
RL01540
S0935
Safinamide
Safinamide (USAN/INN)
Safinamide [USAN:INN]
safinamide methanesulfonate
SAFINAMIDE: - -2-[4- BENZYLAMINO]PROPANAMIDEMETHANSULFONATE
SC-89769
SCHEMBL69350
ST24035822
TC-147411
UNII-90ENL74SIG
W-5197
ZINC53084692

US Patents and Regulatory Information for XADAGO

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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0054 France ➤ Sign Up PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224
/2015 Austria ➤ Sign Up PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224
1 50017-2015 Slovakia ➤ Sign Up PRODUCT NAME: SAFINAMID; REGISTRATION NO/DATE: EU/1/14/984/001 - EU/1/14/984/010 20150226
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Harvard Business School
Deloitte
Teva
Boehringer Ingelheim
Julphar
Fuji
Federal Trade Commission
Farmers Insurance

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