NDAORALTABLET1 Generic Approved
Approved
Jun 1995
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
10
Data completeness
3/8 — Basic
Drug data last refreshed 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VALTREX (valacyclovir hydrochloride) is an oral antiviral nucleoside analog prodrug used to treat herpes simplex virus (HSV) infections, varicella-zoster virus (VZV), and Epstein-Barr virus (EBV) infections. It is converted in the body to acyclovir, which inhibits viral DNA polymerase to prevent viral replication. The drug is indicated for treatment and suppression of genital herpes, cold sores, and shingles.
$0.005BPart D
LOE ApproachingAs LOE approaches, brand teams are transitioning focus from volume growth to managed decline and cost optimization, with smaller core teams maintaining legacy assets.
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 (10)
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
Fasting Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg
Started May 2005
28 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.