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Last Updated: November 5, 2024

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*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
Wellstat TherapeuticsPhase 3
Wellstat Therapeutics

See all URIDINE TRIACETATE clinical trials

Pharmacology for URIDINE TRIACETATE

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
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

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

Country Patent Number Title Estimated Expiration
European Patent Office 0339075 ACYLATED URIDINE AND CYTIDINE AND USES THEREOF ⤷  Sign Up
Japan 2894610 ⤷  Sign Up
Denmark 1491201 ⤷  Sign Up
Mexico 9203963 AGENTES QUIMIOTERAPEUTICOS Y ANTIVIRALES CON TOXICIDAD REDUCIDA. ⤷  Sign Up
Australia 712835 ⤷  Sign Up
Norway 317199 ⤷  Sign Up
Japan 2006096772 OXYPURINE NUCLEOSIDE FOR IMPROVING HEMOPOIESIS, HOMOLOGUE THEREOF AND ACYL DERIVATIVE THEREOF ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for URIDINE TRIACETATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1849470 CA 2017 00036 Denmark ⤷  Sign Up PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427
1849470 2017C/028 Belgium ⤷  Sign Up PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
2207786 2023C/551 Belgium ⤷  Sign Up PRODUCT NAME: UNE COMPOSITION COMPRENANT : DE LA CEDAZURIDINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ; ET LA DECITABINE; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918
1849470 1790063-0 Sweden ⤷  Sign Up PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1096 20160427
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 LUC00327 Luxembourg ⤷  Sign Up PRODUCT NAME: CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/23/1756 20230918
2207786 301257 Netherlands ⤷  Sign Up PRODUCT NAME: SAMENSTELLING WELKE OMVAT: CEDAZURIDINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; EN DECITABINE; REGISTRATION NO/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.