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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-six 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.

US ANDA Litigation and Generic Entry Outlook for Xadago

Xadago will be eligible for patent challenges on March 21, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 10, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for XADAGO

International Patents:	96
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	56
Clinical Trials:	4
Patent Applications:	208
Drug Prices:	Drug price information for XADAGO
DailyMed Link:	XADAGO at DailyMed

See drug prices for XADAGO

Generic Entry Opportunity Date for XADAGO

NDA:

207145

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

Sponsor	Phase
Alain Kaelin	Phase 4
Clinical Trial Unit Ente Ospedaliero Cantonale	Phase 4
IRCCS San Raffaele	Phase 4

See all XADAGO clinical trials

Pharmacology for XADAGO

Drug Class	Monoamine Oxidase Type B Inhibitor
Mechanism of Action	Monoamine Oxidase-B Inhibitors Breast Cancer Resistance Protein Inhibitors

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
Us Worldmeds Llc	XADAGO	safinamide mesylate	TABLET;ORAL	207145-002	Mar 21, 2017		RX	Yes	Yes			Y	Y
Us Worldmeds Llc	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017		RX	Yes	No
Us Worldmeds Llc	XADAGO	safinamide mesylate	TABLET;ORAL	207145-002	Mar 21, 2017		RX	Yes	Yes
Us Worldmeds Llc	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017		RX	Yes	No			Y	Y
Us Worldmeds Llc	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017		RX	Yes	No				Y

International Patents for XADAGO

Country	Patent Number	Estimated Expiration
Germany	602004021790
Cyprus	1109295
Norway	20054640
Portugal	1613296
Netherlands	300752
Denmark	2070526

Supplementary Protection Certificates for XADAGO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613296	46/2015	Austria		PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224
1613296	CA 2015 00042	Denmark		PRODUCT NAME: KOMBINATION AF SAFINAMID OG LEVOPODA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150224
1613296	122015000058	Germany		PRODUCT NAME: XADAGO; REGISTRATION NO/DATE: EU/1/14/984 20150224
1613296	92782	Luxembourg		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		PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226
1613296	241 50017-2015	Slovakia		PRODUCT NAME: SAFINAMID; REGISTRATION NO/DATE: EU/1/14/984/001 - EU/1/14/984/010 20150226