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Last Updated: March 1, 2021

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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
Recent Clinical Trials for uridine triacetate

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

SponsorPhase
Wellstat TherapeuticsPhase 2
Wellstat TherapeuticsN/A

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
Wellstat Therap XURIDEN uridine triacetate GRANULE;ORAL 208169-001 Sep 4, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Wellstat Therap VISTOGARD uridine triacetate GRANULE;ORAL 208159-001 Dec 11, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Wellstat Therap VISTOGARD uridine triacetate GRANULE;ORAL 208159-001 Dec 11, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Wellstat Therap VISTOGARD uridine triacetate GRANULE;ORAL 208159-001 Dec 11, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Wellstat Therap XURIDEN uridine triacetate GRANULE;ORAL 208169-001 Sep 4, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Wellstat Therap XURIDEN uridine triacetate GRANULE;ORAL 208169-001 Sep 4, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Wellstat Therap VISTOGARD uridine triacetate GRANULE;ORAL 208159-001 Dec 11, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for uridine triacetate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1849470 1790063-0 Sweden   Start Trial PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1096 20160427
1849470 2017C/028 Belgium   Start Trial PRODUCT NAME: LONSURF - TRIFLURIDINE/TIPIRACIL; AUTHORISATION NUMBER AND DATE: EU/1/16/1096 20160427
1849470 LUC00036 Luxembourg   Start Trial 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   Start Trial 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   Start Trial PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160425
1849470 17C1028 France   Start Trial PRODUCT NAME: TRIFLURIDINE/TIPIRACIL; REGISTRATION NO/DATE: EU/1/16/1096 20160427
1849470 300889 Netherlands   Start Trial PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
AstraZeneca
Dow
Express Scripts
Boehringer Ingelheim

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