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Uridine triacetate - Generic Drug Details

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What are the generic sources for uridine triacetate and what is the scope of patent protection?

Uridine triacetate is the generic ingredient in two branded drugs marketed by Wellstat Therap and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Uridine triacetate has one hundred and seventy-five patent family members in twenty-one countries.

There are thirty-six drug master file entries for uridine triacetate. One supplier is listed for this compound.

Summary for uridine triacetate

International Patents:	175
US Patents:	2
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	36
Suppliers / Packagers:	1
Bulk Api Vendors:	60
Clinical Trials:	2
Patent Applications:	234
Formulation / Manufacturing:	see details
DailyMed Link:	uridine triacetate at DailyMed

Recent Clinical Trials for uridine triacetate

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

Sponsor	Phase
Wellstat Therapeutics	Phase 2
Wellstat Therapeutics	N/A

See all uridine triacetate clinical trials

Pharmacology for uridine triacetate

Ingredient-type	Pyrimidines Analogs/Derivatives
Drug Class	Pyrimidine Analog

US Patents and Regulatory Information for uridine triacetate

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
Wellstat Therap	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015		RX	Yes	Yes
Wellstat Therap	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015		RX	Yes	Yes
Wellstat Therap	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015		RX	Yes	Yes			Y
Wellstat Therap	XURIDEN	uridine triacetate	GRANULE;ORAL	208169-001	Sep 4, 2015		RX	Yes	Yes
Wellstat Therap	XURIDEN	uridine triacetate	GRANULE;ORAL	208169-001	Sep 4, 2015		RX	Yes	Yes			Y
Wellstat Therap	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015		RX	Yes	Yes

Expired US Patents for uridine triacetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wellstat Therap	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015

International Patents for uridine triacetate

Country	Patent Number	Estimated Expiration
Australia	610315
Israel	107900
World Intellectual Property Organization (WIPO)	9601115
Australia	7881398
Canada	2100655
Australia	6081294
Israel	88208

Supplementary Protection Certificates for uridine triacetate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1849470	1790063-0	Sweden		PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. 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
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	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	2017/033	Ireland		PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160425
1849470	17C1028	France		PRODUCT NAME: TRIFLURIDINE/TIPIRACIL; REGISTRATION NO/DATE: EU/1/16/1096 20160427
1849470	300889	Netherlands		PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427