VALTREX
LOE ApproachingNDAOralTabletPriority Review
Approved
Dec 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
5/8 — Partial
Priority Review
VALTREX by GSK is α-herpes viruses [see microbiology ()]. Approved for cold sores (herpes labialis), the initial episode of genital herpes in immunocompetent adults, recurrent episodes of genital herpes in immunocompetent adults and 5 more indications. First approved in 1995.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VALTREX is an oral antiviral small molecule approved in 1995 for herpes virus infections. The drug targets viral replication in patients with herpes simplex virus (HSV) and varicella-zoster virus (VZV) infections. It represents a foundational antiviral therapy in the herpes treatment landscape.
$0.005BPart D
LOE ApproachingProduct approaching loss of exclusivity with moderate Medicare utilization; expect commercial team focus on cost management and market defense.
Mechanism of Action
α-herpes viruses [see Microbiology ()].
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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.