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 3d ago · AI intelligence enriched 4w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SPORANOX (itraconazole) is an oral antifungal solution approved in 1997 that inhibits fungal cell membrane synthesis by blocking cytochrome P450-dependent ergosterol production. It is indicated for medical oncology applications where fungal infections complicate cancer treatment. The drug is administered orally as a solution formulation.
$0.197MPart D
LOE ApproachingMature product with minimal prescription volume (95 Part D claims in 2023) and approaching loss of exclusivity, suggesting a small, stable brand team focused on maintenance rather than growth.
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.