MYCELEX
LOE ApproachingNDAORALTROCHE/LOZENGE
Approved
Jun 1983
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
MYCELEX by Bayer is clinical pharmacology clotrimazole is a broad-spectrum antifungal agent that inhibits the growth of pathogenic yeasts by altering the permeability of cell membranes. First approved in 1983.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MYCELEX (clotrimazole) is a broad-spectrum antifungal agent administered as an oral troche that inhibits pathogenic yeast growth by altering cell membrane permeability. It is primarily used to treat oral candidiasis (thrush) and other Candida infections, demonstrating fungistatic activity at therapeutic concentrations with potential fungicidal effects at higher levels. The drug maintains therapeutic salivary concentrations for up to three hours per dose, enabling three-hour dosing intervals to sustain antifungal effect.
LOE Approaching
As an established oral antifungal approaching loss of exclusivity with moderate competitive pressure (30%), team sizes on this product are likely contracted and focused on generic transition management rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Clotrimazole is a broad-spectrum antifungal agent that inhibits the growth of pathogenic yeasts by altering the permeability of cell membranes. The action of clotrimazole is fungistatic at concentrations of drug up to 20 mcg/mL and may be fungicidal in vitro against Candida…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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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.