NDAINJECTIONINJECTABLEPriority Review
Approved
Oct 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
3/8 — Basic
Priority Review
MONISTAT (miconazole) by Johnson & Johnson is 12. First approved in 1978.
Drug data last refreshed 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MONISTAT (miconazole) is a small-molecule antifungal agent that inhibits cytochrome P450 14α-demethylase, disrupting ergosterol synthesis in fungal cell membranes. It is primarily used to treat oropharyngeal candidiasis and other candida infections caused by C. albicans, C. parapsilosis, and C. tropicalis. The drug demonstrates broad-spectrum activity with local buccal delivery (ORAVIG formulation) achieving therapeutic salivary concentrations while minimizing systemic absorption.
LOE Approaching
Product is approaching loss of exclusivity with limited commercial expansion potential; teams are typically focused on defensive positioning and managed care negotiations rather than growth initiatives.
Mechanism of Action
12.1 Mechanism of Action Miconazole is an antifungal drug 12.3 Pharmacokinetics Absorption and Distribution Salivary Single dose application of ORAVIG containing 50 mg of miconazole to the buccal mucosa of 18 healthy volunteers provided mean maximum salivary concentrations of 15 mcg/mL at 7 hours…
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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.