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Uridine triacetate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for uridine triacetate?

Uridine triacetate is the generic ingredient in two branded drugs marketed by Wellstat Therap and is included in two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Uridine triacetate has one hundred and seventy-two 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 Generic Name: uridine triacetate

Tradenames:2
Patents:4
Applicants:1
NDAs:2
Drug Master File Entries: see list35
Suppliers / Packagers: see list1
Bulk Api Vendors: see list48
Clinical Trials: see list25
Patent Applications: see list36
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:uridine triacetate at DailyMed

Pharmacology for Ingredient: uridine triacetate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wellstat Therap
VISTOGARD
uridine triacetate
GRANULE;ORAL208159-001Dec 11, 2015RXYesYes5,968,914► Subscribe ► Subscribe
Wellstat Therap
VISTOGARD
uridine triacetate
GRANULE;ORAL208159-001Dec 11, 2015RXYesYes► Subscribe► Subscribe
Wellstat Therap
XURIDEN
uridine triacetate
GRANULE;ORAL208169-001Sep 4, 2015RXYesYes6,258,795► SubscribeY ► Subscribe
Wellstat Therap
VISTOGARD
uridine triacetate
GRANULE;ORAL208159-001Dec 11, 2015RXYesYes7,776,838► Subscribe ► Subscribe
Wellstat Therap
XURIDEN
uridine triacetate
GRANULE;ORAL208169-001Sep 4, 2015RXYesYes► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: uridine triacetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wellstat Therap
VISTOGARD
uridine triacetate
GRANULE;ORAL208159-001Dec 11, 20155,968,914► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
6,316,426 Acylated uridine and cytidine and uses thereof► Subscribe
7,166,581Treatment of chemotherapeutic agent and antiviral agent toxicity with acylated pyrimidine nucleosides► Subscribe
6,232,298 Pyrimidine nucleotide precursors for treatment of systemic inflammation and inflammatory hepatitis► Subscribe
5,246,708 Methods for promoting wound healing with deoxyribonucleosides► Subscribe
6,060,459 Enhancing blood cell count with oxypurine nucleosides► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: uridine triacetate

Country Document Number Estimated Expiration
South Africa9200914► Subscribe
Israel107900► Subscribe
Japan2008007525► Subscribe
Israel100874► Subscribe
Israel88204► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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.

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