VISTOGARD
LOE Approachinguridine triacetate
NDAORALGRANULEPriority Review
Approved
Dec 2015
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 16h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VISTOGARD (uridine triacetate) is an oral granule formulation that functions as a uridine replacement therapy. It is indicated for emergency treatment of patients who have received a fluoropyrimidine overdose or exhibit early-onset severe toxicity from fluoropyrimidine-based chemotherapy. The drug works by providing exogenous uridine to bypass the toxic metabolic pathway of fluoropyrimidines.
LOE Approaching1.1 years to LOE
Narrow indication and approaching loss of exclusivity (2027) suggest a small, specialized commercial team managing limited but critical market.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Why This Matters for Your Career
Patent cliff in ~2 years — expect lifecycle management and generic defense hiring
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.