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XADAGO Drug Profile

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When do Xadago patents expire, and when can generic versions of Xadago launch?

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-seven 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:	97
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	57
Clinical Trials:	4
Patent Applications:	209
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

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			Y	Y
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

International Patents for XADAGO

Country	Patent Number	Estimated Expiration
Norway	342018
South Korea	101129015
South Korea	20060010745

Supplementary Protection Certificates for XADAGO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613296	C 2015 034	Romania		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	132016000023012	Italy		PRODUCT NAME: SAFINAMIDE(XADAGO); AUTHORISATION NUMBER(S) AND DATE(S): 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