Details for New Drug Application (NDA): 208159
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NDA 208159 describes VISTOGARD, which is a drug marketed by Wellstat Therap and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the VISTOGARD profile page.
The generic ingredient in VISTOGARD 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 VISTOGARD 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 208159
| Tradename: | VISTOGARD |
| Applicant: | Wellstat Therap |
| Ingredient: | uridine triacetate |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 208159
Generic Entry Date for 208159*:
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: 208159
| Ingredient-type | Analogs/Derivatives Pyrimidines |
Suppliers and Packaging for NDA: 208159
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159 | NDA | Wellstat Therapeutics Corporation | 69468-151 | 69468-151-04 | 4 PACKET in 1 CARTON (69468-151-04) / 10 g in 1 PACKET (69468-151-10) |
| VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159 | NDA | Wellstat Therapeutics Corporation | 69468-151 | 69468-151-10 | 10 g in 1 PACKET (69468-151-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 10GM/PACKET | ||||
| Approval Date: | Dec 11, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 11, 2022 | ||||||||
| Regulatory Exclusivity Use: | EMERGENCY TX OF PTS FOLLOWING A FU OR CAPECITABINE OD, OR WHO EXHIBIT EARLY-ONSET, SEVERE OR LIFE-THREATENING TOXICITY AFFECTING THE CARDIAC SYSTEM OR CNS, AND/OR EARLY-ONSET, UNUSUALLY SEVERE AR W/IN 96 HRS FOLLOWING THE END OF FU OR CAPECITABINE ADMIN. | ||||||||
| Patent: | See Plans and Pricing | Patent Expiration: | Jul 10, 2023 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | See Plans and Pricing | Patent Expiration: | Aug 17, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | EMERGENCY TREATMENT OF ADULT & PEDIATRIC PATIENTS FOLLOWING FLUOROURACIL OR CAPECITABINE OVERDOSE,OR WHO EXHIBIT EARLY-ONSET,SEVERE OR LIFE-THREATENING CARDIAC OR CNS TOXICITY OR UNUSUALLY SEVERE ADVERSE REACTIONS WITHIN 96 HOURS | ||||||||
Expired US Patents for NDA 208159
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Wellstat Therap | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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