Details for New Drug Application (NDA): 208169
✉ Email this page to a colleague
▶ 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.
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
| Ingredient-type | Analogs/Derivatives Pyrimidines |
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: | RX | Dosage: | GRANULE;ORAL | Strength | 2GM/PACKET | ||||
| Approval Date: | Sep 4, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 4, 2022 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF HEREDITARY OROTIC ACIDURIA | ||||||||
| Patent: | See Plans and Pricing | Patent Expiration: | Jul 10, 2023 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Complete Access Available with Subscription
