Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Baxter
Dow
Express Scripts
McKinsey
Johnson and Johnson
McKesson

Last Updated: November 20, 2019

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XADAGO Drug Profile

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Summary for XADAGO
Drug patent expirations by year for XADAGO
Drug Prices for XADAGO

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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.

Recent Clinical Trials for XADAGO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Clinical Trial Unit Ente Ospedaliero CantonalePhase 4
Alain KaelinPhase 4
IRCCS San RaffaelePhase 4

See all XADAGO clinical trials

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
BCP12082
BDBM19187
BDBM50078694
CHEBI:134718
CHEMBL396778
CHEMBL48582
CS-0556
CTK8B7808
D10158
DB06654
EC 603-772-2
EMD 1195686
EMD-1195686
EX-A2759
Fce-26743
FT-0700949
GTPL8291
HY-70057
J-506604
MolPort-005-942-375
N2-(4-((3-Fluorbenzyl)oxy)benzyl)-L-alaninamid
NCGC00346529-01
NEMGRZFTLSKBAP-LBPRGKRZSA-N
P111001
Propanamide, 2-(((4-((3-fluorophenyl)methoxy)phenyl)methyl)amino)-, (S)-
RL01540
S0935
Safinamide
Safinamide (USAN/INN)
Safinamide [USAN:INN]
SB16691
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   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 Y   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   Start Trial
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 207145-001 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   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 XADAGO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1613296 46/2015 Austria   Start Trial PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224
1613296 300752 Netherlands   Start Trial PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224
1613296 122015000058 Germany   Start Trial PRODUCT NAME: XADAGO; REGISTRATION NO/DATE: EU/1/14/984 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 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 C20150033 00258 Estonia   Start Trial PRODUCT NAME: SAFINAMIID;REG NO/DATE: EU/1/14/984 26.02.2015
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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Serving leading biopharmaceutical companies globally:

Medtronic
Moodys
Merck
Colorcon
Baxter
Johnson and Johnson

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 verifification 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.