NDAORALFOR SOLUTIONPriority Review
Approved
Aug 2009
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
12
Data completeness
4/8 — Partial
Priority Review
VALCYTE (valganciclovir hydrochloride) by Lavipharm is [see microbiology ()] . First approved in 2009.
Drug data last refreshed 23h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VALCYTE is an oral antiviral prodrug of ganciclovir used primarily for cytomegalovirus (CMV) prevention and treatment in immunocompromised patients, particularly transplant recipients. It is converted to ganciclovir in vivo, where it inhibits viral DNA polymerase to prevent CMV replication.
LOE Approaching1.2 years to LOE
Product approaching loss of exclusivity with moderate competitive intensity (15 competitors), suggesting smaller team sizes and transition focus toward lifecycle extension or product defense strategies.
Mechanism of Action
[see Microbiology ()] .
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls
Started Jan 2012
59 enrolled
Cytomegalovirus Infections
A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients
Started Jul 2011
57 enrolled
Kidney Transplantation, Cytomegalovirus Infections
Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fed Condition
Started Jul 2011
66 enrolled
Healthy
Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fasting Condition
Started Jul 2011
83 enrolled
Healthy
A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age
Started May 2011
17 enrolled
Cytomegalovirus Infections, Heart Transplantation
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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.