NDAORALTABLET1 Generic Approved
Approved
Jun 1995
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
7
Data completeness
3/8 — Basic
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VALTREX (valacyclovir hydrochloride) is an oral antiviral small molecule approved in 1995 for treatment of herpes simplex virus (HSV) and varicella-zoster virus (VZV) infections. It is a prodrug of acyclovir that inhibits viral DNA polymerase, reducing viral replication and symptom duration. This drug serves as a standard-of-care treatment for genital herpes, cold sores, and shingles across multiple patient populations.
$5.0MPart D
LOE ApproachingBrand is in late-stage lifecycle with modest Medicare spending; commercial teams are likely focused on generic transition planning and niche patient retention rather than growth initiatives.
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 (7)
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
VALTREX Once Daily For Viral Shedding In Herpes Simplex Virus 2 (HSV-2) Seropositive Subjects. VALTREX® Tablet is a Trademark of GlaxoSmithKline Group of Companies.
Started Mar 2005
73 enrolled
Infections, Herpesviridae
A Study Comparing Daily Treatment With Valaciclovir To Placebo For Suppression Of Herpes Simplex Virus HSV-2 Genital Herpes In Newly Diagnosed Patients. VALTREX® Tablet is a Trademark of the GlaxoSmithKline Group of Companies.
Started Jun 2004
384 enrolled
Herpes Genitalis
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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.