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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
QuintilesIMS
Boehringer Ingelheim
Medtronic
Farmers Insurance
UBS
Fuji
Fish and Richardson
Cerilliant
Federal Trade Commission

Generated: January 16, 2018

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-five 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
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, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Sep 4, 2022
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:➤ SubscribePatent Expiration:Jul 10, 2018Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Medtronic
Baxter
Farmers Insurance
Merck
Harvard Business School
Accenture
McKinsey
Julphar
Fish and Richardson

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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