NDAORALTABLETPriority Review
Approved
Mar 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
VALCYTE (valganciclovir) by Hetero is dna polymerase inhibitors [moa]. Approved for cytomegalovirus infections, cytomegalovirus retinitis, kidney transplantation. First approved in 2001.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VALCYTE (valganciclovir) is an oral antiviral that inhibits DNA polymerase to treat cytomegalovirus (CMV) infections across multiple immunocompromised populations. It is indicated for CMV retinitis, prevention and treatment of CMV in transplant recipients (kidney, heart, lung, liver, bone marrow, stem cell), HIV-infected patients, and congenital CMV infection. The drug is a prodrug of ganciclovir with improved oral bioavailability.
$318KPart D
LOE ApproachingMinimal commercial activity with approaching loss of exclusivity signals limited team expansion and focus on transition planning rather than growth initiatives.
Mechanism of Action
DNA Polymerase Inhibitors
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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.