XURIDEN Drug Patent Profile

When do Xuriden patents expire, and what generic alternatives are available?

Xuriden is a drug marketed by Wellstat Therap and is included in one NDA. There is one patent protecting this drug.

This drug has one hundred and seventy-five patent family members in twenty-one countries.

The generic ingredient in XURIDEN is uridine triacetate. There are thirty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the uridine triacetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Xuriden

Xuriden was eligible for patent challenges on September 4, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 10, 2023. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for XURIDEN

International Patents:	175
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	66
Patent Applications:	267
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in XURIDEN?	XURIDEN excipients list
DailyMed Link:	XURIDEN at DailyMed

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for XURIDEN

NDA:

208169

Dosage:

GRANULE;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.

Pharmacology for XURIDEN

Ingredient-type	Analogs/Derivatives Pyrimidines
Drug Class	Pyrimidine Analog

Anatomical Therapeutic Chemical (ATC) Classes for XURIDEN

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for XURIDEN

XURIDEN is protected by one 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 XURIDEN

FDA Regulatory Exclusivity protecting XURIDEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wellstat Therap	XURIDEN	uridine triacetate	GRANULE;ORAL	208169-001	Sep 4, 2015		RX	Yes	Yes			Y
Wellstat Therap	XURIDEN	uridine triacetate	GRANULE;ORAL	208169-001	Sep 4, 2015		RX	Yes	Yes

International Patents for XURIDEN

See the table below for patents covering XURIDEN around the world.

Country	Patent Number	Title	Estimated Expiration
China	1095268
Spain	2160579
Australia	6081294
Germany	3883374
European Patent Office	0594667	TRAITEMENT D'UN AGENT CHIMIOTHERAPEUTIQUE ET DE LA TOXICITE D'UN AGENT ANTIVIRAL PAR DES NUCLEOSIDES DE PYRIMIDINE ACYLEE (TREATMENT OF CHEMOTHERAPEUTIC AGENT AND ANTIVIRAL AGENT TOXICITY WITH ACYLATED PYRIMIDINE NUCLEOSIDES)
Australia	3278495

Supplementary Protection Certificates for XURIDEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1849470	2017C/028	Belgium		PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
1849470	17C1028	France		PRODUCT NAME: TRIFLURIDINE/TIPIRACIL; REGISTRATION NO/DATE: EU/1/16/1096 20160427
1849470	CA 2017 00036	Denmark		PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427
1849470	LUC00036	Luxembourg		PRODUCT NAME: TRIFLURIDINE COMBINEE AU TIPIRACIL OU UN SEL DE TIPIRACIL TEL QUE L'HYDROCHLORURE DE TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
1849470	300889	Netherlands		PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427
1849470	2017/033	Ireland		PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160425