XURIDEN Drug Patent Profile

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

Xuriden is a drug marketed by Btg Intl and is included in one NDA.

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.

Summary for XURIDEN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Patent Applications:	330
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in XURIDEN?	XURIDEN excipients list
DailyMed Link:	XURIDEN at DailyMed

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

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

Expired US Patents for XURIDEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Btg Intl	XURIDEN	uridine triacetate	GRANULE;ORAL	208169-001	Sep 4, 2015

International Patents for XURIDEN

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

Country	Patent Number	Title	Estimated Expiration
Finland	941245
Japan	H07228535	MEDICAL COMPONENT CONTAINING ACYL DERIVATIVE OF URIDINE OR CYTIDINE
Australia	2722688
Israel	107900	Composition comprising an acyl derivative of a pyrimidine nucleotide precursor and an inhibitor of uridine phosphorylase or/and a purine nucleotide precursor for use in treatment and prevention of systemic inflammation inflammatory hepatitis and similar conditions and use of such components in the manufacture of medicaments
Germany	3856557
European Patent Office	1486210
Israel	88208	Pharmaceutical compositions containing acyl-substituted uridines and cytidines and some novel compounds of this type

Supplementary Protection Certificates for XURIDEN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2207786	LUC00326	Luxembourg		PRODUCT NAME: COMPOSITION COMPRENANT: DE LA CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; ET DE LA DECITABINE; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230913
1849470	17C1028	France		PRODUCT NAME: TRIFLURIDINE/TIPIRACIL; REGISTRATION NO/DATE: EU/1/16/1096 20160427
2207786	LUC00327	Luxembourg		PRODUCT NAME: CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918
1849470	300889	Netherlands		PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427
1849470	2017C/028	Belgium		PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
2207786	301256	Netherlands		PRODUCT NAME: CEDAZURIDINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1756 20230918
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