XADAGO Drug Patent Profile

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

Xadago is a drug marketed by Mdd Us 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.

DrugPatentWatch^® Generic Entry Outlook for Xadago

Xadago was eligible for patent challenges on March 21, 2021.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for XADAGO

International Patents:	97
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	5
Patent Applications:	671
Drug Prices:	Drug price information for XADAGO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XADAGO
What excipients (inactive ingredients) are in XADAGO?	XADAGO excipients list
DailyMed Link:	XADAGO at DailyMed

See drug prices for XADAGO

Recent Clinical Trials for XADAGO

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

Sponsor	Phase
Zambon SpA	Phase 2
Clinical Trial Unit Ente Ospedaliero Cantonale	Phase 4
Alain Kaelin	Phase 4

See all XADAGO clinical trials

Pharmacology for XADAGO

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

Anatomical Therapeutic Chemical (ATC) Classes for XADAGO

N04BD	Monoamine oxidase B inhibitors
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

US Patents and Regulatory Information for XADAGO

XADAGO is protected by three US patents.

Patents protecting XADAGO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017		RX	Yes	No			Y	Y
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-002	Mar 21, 2017		RX	Yes	Yes				Y
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017		RX	Yes	No				Y
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017		RX	Yes	No
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-002	Mar 21, 2017		RX	Yes	Yes			Y	Y
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-002	Mar 21, 2017		RX	Yes	Yes

International Patents for XADAGO

When does loss-of-exclusivity occur for XADAGO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Norway

Poland

Portugal

Serbia

Slovenia

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XADAGO around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	342698	PROCESO PARA LA PRODUCCION DE 2-[4-(3- Y 2-FLUOROBENCILOXI) BENCILAMINO] PROPANAMIDAS. (PROCESS FOR THE PRODUCTION OF 2- [4 - ( 3- AND 2-FLU0R0BENZYL0XY) BENZYLAMIN0] PROPAN AMIDES.)
Japan	2013139446	MANUFACTURING METHOD FOR 2-[4-(3- AND 2-FLUOROBENZYLOXY)BENZYLAMINO]PROPANAMIDE
Cyprus	1115286
Cyprus	1115951
Taiwan	201313662	High purity degree 2-[4-(3- and 2-fluorobenzyloxy)benzylamino]propanamides
China	103284984	Process for the production of 2-[4-(3- and 2-flu0r0benzyl0xy)benzylamin0]propanamides
Australia	2004228782	Methods for treatment of Parkinson's Disease

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	241 50017-2015	Slovakia		PRODUCT NAME: SAFINAMID; REGISTRATION NO/DATE: EU/1/14/984/001 - EU/1/14/984/010 20150226
1613296	122015000058	Germany		PRODUCT NAME: XADAGO; REGISTRATION NO/DATE: EU/1/14/984 20150224
1613296	15C0054	France		PRODUCT NAME: SAFINAMIDE; 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	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