SPORANOX
LOE ApproachingNDAORALSOLUTIONPriority Review
Approved
Feb 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
Priority Review
SPORANOX by Johnson & Johnson is mechanism of action in vitro studies have demonstrated that itraconazole inhibits the cytochrome p450-dependent synthesis of ergosterol, which is a vital component of fungal cell membranes. Approved for the following fungal infections in immunocompromised, non-immunocompromised patients: blastomycosis, pulmonary and 11 more indications. First approved in 1997.
Drug data last refreshed 1h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SPORANOX (itraconazole) is an oral antifungal solution approved in 1997 that treats serious fungal infections including blastomycosis, histoplasmosis, and aspergillosis in immunocompromised and non-immunocompromised patients, as well as onychomycosis (nail fungus). It works by inhibiting cytochrome P450-dependent ergosterol synthesis, disrupting fungal cell membrane integrity.
$0.197MPart D
LOE ApproachingDeclining
Product approaching loss of exclusivity with minimal Part D utilization signals a contracting commercial footprint and reduced team investment.
Mechanism of Action
Mechanism of Action In vitro studies have demonstrated that itraconazole inhibits the cytochrome P450-dependent synthesis of ergosterol, which is a vital component of fungal cell membranes.
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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.