Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School

Last Updated: March 27, 2023

Details for New Drug Application (NDA): 208169

✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions

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
Applicant:Wellstat Therap
Ingredient:uridine triacetate
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 208169
Generic Entry Date for 208169*:
Constraining patent/regulatory exclusivity:

*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
Patent:See Plans and PricingPatent Expiration:Jul 10, 2023Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts

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.