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Uridine triacetate - Generic Drug Details

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What are the generic drug sources for uridine triacetate and what is the scope of uridine triacetate freedom to operate?

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-five 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:	35
Suppliers / Packagers:	1
Bulk Api Vendors:	50
Clinical Trials:	64
Patent Applications:	58
Formulation / Manufacturing:	see details
DailyMed Link:	uridine triacetate at DailyMed

Pharmacology for uridine triacetate

Ingredient-type	Pyrimidines Analogs/Derivatives
Drug Class	Pyrimidine Analog

Synonyms for uridine triacetate

(2R,3R,4R,5R)-2-(ACETOXYMETHYL)-5-(2,4-DIOXO-3,4-DIHYDROPYRIMIDIN-1(2H)-YL)TETRAHYDROFURAN-3,4-DIYL DIACETATE

[(2R,3R,4R,5R)-3,4-diacetoxy-5-(2,4-dioxopyrimidin-1-yl)tetrahydrofuran-2-yl]methyl acetate

[(2R,3R,4R,5R)-3,4-diacetyloxy-5-(2,4-dioxopyrimidin-1-yl)oxolan-2-yl]methyl acetate

105T388

2 ,3 ,5 -Triacetyluridine

2',3',5'-Tri-O-acetyluridine

293738-13-3

2WP61F175M

4105-38-8

AC1L2FGB

AK-73070

AKOS015964563

AN-158

ANW-29551

API0001026

AUFUWRKPQLGTGF-FMKGYKFTSA-N

AX8007900

CHEBI:90914

CHEMBL2107381

CTK3J5861

D09985

D0OL7F

DB09144

EINECS 223-881-5

FT-0081134

J-700012

KSC495Q6D

MFCD00023795

MLS006009982

MolPort-005-940-324

NU000494

PN 401

PN401

PubChem14176

RG 2133

SCHEMBL871011

SMR004701034

SY004945

Tri-O-acetyluridine

Triacetyluridine

UNII-2WP61F175M

URI007

Uridine 2',3',5'-triacetate

Uridine triacetate (USAN/INN)

Uridine triacetate [USAN:INN]

Uridine, 2',3',5'-triacetate

Vistonuridine

Xuriden

Xuriden (TN)

ZINC3843198

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

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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

Non-Orange Book US Patents for uridine triacetate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,105,498	Acylated uridine and cytidine and uses thereof
5,968,914	Treatment of chemotherapeutic agent and antiviral agent toxicity with acylated pyrimidine nucleosides
5,583,117	Acylated uridine and cytidine for elevating tissue uridine and cytidine
5,246,708	Methods for promoting wound healing with deoxyribonucleosides

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International Patents for uridine triacetate

Country	Document Number	Estimated Expiration
China	1089239
Spain	2257721
Hong Kong	1005740
Israel	100874

Supplementary Protection Certificates for uridine triacetate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0889	Netherlands		PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427