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.

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.

There has been one patent litigation case 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:	69
Clinical Trials:	5
Patent Applications:	823
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

DrugPatentWatch^® Estimated 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
Zambon SpA	Phase 2
Alain Kaelin	Phase 4
Clinical Trial Unit Ente Ospedaliero Cantonale	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 and one FDA Regulatory Exclusivity.

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

Patents protecting XADAGO

FDA Regulatory Exclusivity 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	Y
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-001	Mar 21, 2017		RX	Yes	No

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
Israel	195294	תהליך לייצור ספינאמיד או רלפינאמיד ברמת טהור גבוהה, שימושם בהכנת תרופות ותכשירים רפואיים המכילים אותם (Process for producing high purity safinamide or ralfinamide, use thereof in the preparation of medicaments and pharmaceutical formulations containing them)
Mexico	2008015704	PROCESO PARA LA PRODUCCION DE 2-[4-(3-Y 2-FLUORO BENCILOXI) BENCILAMINO]PROPANAMIDAS. (PROCESS FOR THE PRODUCTION OF 2- [4 - ( 3- AND 2-FLU0R0BENZYL0XY) BENZYLAMIN0] PROPAN AMIDES.)
Japan	2009541232

Supplementary Protection Certificates for XADAGO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613296	15C0054	France		PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 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