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Last Updated: June 9, 2023

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.

One supplier is listed for this compound.

Summary for uridine triacetate
International Patents:175
US Patents:2
Tradenames:2
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 73
Clinical Trials: 2
Patent Applications: 547
Formulation / Manufacturing:see details
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 Dates for uridine triacetate*:
Constraining patent/regulatory exclusivity:
Dosage:
GRANULE;ORAL
Generic Entry Dates 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
Wellstat Therap VISTOGARD uridine triacetate GRANULE;ORAL 208159-001 Dec 11, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Wellstat Therap XURIDEN uridine triacetate GRANULE;ORAL 208169-001 Sep 4, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Wellstat Therap VISTOGARD uridine triacetate GRANULE;ORAL 208159-001 Dec 11, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Wellstat Therap XURIDEN uridine triacetate GRANULE;ORAL 208169-001 Sep 4, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for uridine triacetate

Country Patent Number Title Estimated Expiration
Israel 107900 Composition comprising an acyl derivative of a pyrimidine nucleotide precursor and an inhibitor of uridine phosphorylase or/and a purine nucleotide precursor for use in treatment and prevention of systemic inflammation inflammatory hepatitis and similar conditions and use of such components in the manufacture of medicaments ⤷  Try a Trial
Japan 4408450 ⤷  Try a Trial
Australia 2254492 ⤷  Try a Trial
Germany 68910973 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for uridine triacetate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1849470 1790063-0 Sweden ⤷  Try a Trial PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1096 20160427
1849470 2017/033 Ireland ⤷  Try a Trial PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160425
1849470 SPC/GB17/049 United Kingdom ⤷  Try a Trial PRODUCT NAME: TRIFLURIDINE WITH TIPACRIL HYDROCHLORIDE; REGISTERED: UK EU/1/16/1096/001(NI) 20160427; UK EU/1/16/1096/002(NI) 20160427; UK EU/1/16/1096/003(NI) 20160427; UK EU/1/16/1096/004(NI) 20160427; UK EU/1/16/1096/005(NI) 20160427; UK EU/1/16/1096/006(NI) 20160427; UK PLGB 05815/0112 20160427; UK PLGB 05815/0113 20160427
1849470 CA 2017 00036 Denmark ⤷  Try a Trial PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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