VALTREX
LOE ApproachingNDAOralTabletPriority Review
Approved
Dec 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 23h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VALTREX (valacyclovir) is an oral antiviral small molecule that inhibits α-herpes viruses by blocking viral DNA replication. It treats cold sores, genital herpes, shingles, and chickenpox in immunocompetent populations across pediatric and adult age groups. The drug is indicated for both acute episodes and transmission prevention.
$5MPart D
LOE ApproachingDeclining
Mature product approaching loss of exclusivity with minimal Part D utilization; expect team rationalization and transition planning.
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 (6)
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.