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Last Updated: November 30, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208169


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NDA 208169 describes XURIDEN, which is a drug marketed by Wellstat Therap and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the XURIDEN profile page.

The generic ingredient in XURIDEN is uridine triacetate. There are thirty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the uridine triacetate profile page.
Summary for 208169
Tradename:XURIDEN
Applicant:Wellstat Therap
Ingredient:uridine triacetate
Patents:1
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 208169
Generic Entry Date for 208169*:
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.

Pharmacology for NDA: 208169
Suppliers and Packaging for NDA: 208169
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XURIDEN uridine triacetate GRANULE;ORAL 208169 NDA Wellstat Therapeutics Corporation 69468-152 69468-152-02 2 g in 1 PACKET (69468-152-02)
XURIDEN uridine triacetate GRANULE;ORAL 208169 NDA Wellstat Therapeutics Corporation 69468-152 69468-152-30 30 PACKET in 1 CARTON (69468-152-30) > 2 g in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength2GM/PACKET
Approval Date:Sep 4, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 4, 2022
Regulatory Exclusivity Use:TREATMENT OF HEREDITARY OROTIC ACIDURIA
Patent:⤷  Free Forever TrialPatent Expiration:Jul 10, 2023Product Flag?YSubstance Flag?Delist Request?

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