NDAOPHTHALMICSOLUTION/DROPSPriority Review
Approved
Apr 1980
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
VIROPTIC (trifluridine) by Monarch Therapeutics is nucleic acid synthesis inhibitors [moa]. Approved for metastatic colorectal cancer, refractory metastatic colorectal cancer, herpes simplex. First approved in 1980.
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VIROPTIC (trifluridine) is a nucleic acid synthesis inhibitor approved as an ophthalmic solution for herpes simplex keratitis and also indicated for metastatic colorectal cancer. It works by inhibiting viral DNA synthesis and thymidylate synthase, making it a dual-indication product spanning ophthalmology and oncology.
LOE Approaching
Product is in advanced decline with LOE approaching, signaling a small and contracting commercial team focused on lifecycle management and generic transition planning.
Mechanism of Action
Nucleic Acid Synthesis Inhibitors
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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.