VALTREX
LOE ApproachingNDAOralTabletPriority Review
Approved
Dec 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
9
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 2h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VALTREX is an oral antiviral medication approved in 1995 for the treatment of herpesvirus infections. The drug is a small molecule that inhibits viral DNA replication in herpes simplex virus (HSV) and varicella-zoster virus (VZV) infections. It represents a foundational therapy in the antiviral treatment landscape.
$5MPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Part D spending, indicating a maturing brand with potential team restructuring ahead.
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.
Clinical Trials (9)
Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)
Started Nov 2007
379 enrolled
Varicella
Special Drug Use Investigation for VALTREX (Valaciclovir) (Suppression Prophylaxis)
Started Nov 2006
462 enrolled
Genital Herpes
VALTREX(Valacyclovir) Once Daily for Viral Shedding In Subjects Newly Diagnosed With HSV-2
Started Feb 2006
70 enrolled
Herpes Labialis
Fed Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg
Started Aug 2005
66 enrolled
Healthy
Food Study of Valacyclovir Hydrochloride Tablets 1000 mg to Valtrex® Tablets 1000 mg
Started May 2005
26 enrolled
Healthy
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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.