URIDINE TRIACETATE - Generic Drug Details

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

Uridine triacetate is the generic ingredient in two branded drugs marketed by Btg Intl and is included in two NDAs. There is one patent 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.

Two suppliers are listed for this compound.

Summary for URIDINE TRIACETATE

International Patents:	175
US Patents:	1
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	2
Patent Applications:	552
What excipients (inactive ingredients) are in URIDINE TRIACETATE?	URIDINE TRIACETATE excipients list
DailyMed Link:	URIDINE TRIACETATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for URIDINE TRIACETATE

Generic Entry Date for URIDINE TRIACETATE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Recent Clinical Trials for URIDINE TRIACETATE

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

Sponsor	Phase
Wellstat Therapeutics	Phase 3
Wellstat Therapeutics

See all URIDINE TRIACETATE clinical trials

Pharmacology for URIDINE TRIACETATE

Ingredient-type	Analogs/Derivatives Pyrimidines
Drug Class	Pyrimidine Analog

Anatomical Therapeutic Chemical (ATC) Classes for URIDINE TRIACETATE

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 URIDINE TRIACETATE

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Btg Intl	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for URIDINE TRIACETATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Btg Intl	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015	⤷ Sign Up	⤷ Sign Up
Btg Intl	XURIDEN	uridine triacetate	GRANULE;ORAL	208169-001	Sep 4, 2015	⤷ Sign Up	⤷ Sign Up
Btg Intl	VISTOGARD	uridine triacetate	GRANULE;ORAL	208159-001	Dec 11, 2015	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for URIDINE TRIACETATE

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Country	Patent Number	Title	Estimated Expiration
Japan	2009167213	METHOD OF DECREASING TOXICITY OF CHEMOTHERAPY AGENT AND ANTIVIRUS AGENT BY ACYLATED PYRIMIDINE NUCLEOSIDE	⤷ Sign Up
World Intellectual Property Organization (WIPO)	8903838		⤷ Sign Up
Australia	2722688		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for URIDINE TRIACETATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2207786	LUC00326	Luxembourg	⤷ Sign Up	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	LUC00036	Luxembourg	⤷ Sign Up	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
2207786	2023C/550	Belgium	⤷ Sign Up	PRODUCT NAME: CEDAZURIDINE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.