NDAORALFOR SUSPENSION
Approved
Dec 1993
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
DIFLUCAN (fluconazole) by Pfizer is cytochrome p450 2c19 inhibitors [moa]. First approved in 1993.
Drug data last refreshed 2h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DIFLUCAN (fluconazole) is an oral azole antifungal that inhibits fungal cytochrome P450 2C19, disrupting ergosterol synthesis in fungal cell membranes. It treats systemic and localized fungal infections across multiple indications including candidiasis, cryptococcosis, and other mycotic diseases. The drug has been a cornerstone therapy for fungal infections since its 1993 approval.
$0.229MPart D
LOE ApproachingDeclining
Product approaching loss of exclusivity with modest Part D spending suggests a mature, declining franchise requiring defensive commercial strategies.
Mechanism of Action
Cytochrome P450 2C19 Inhibitors
Pharmacologic Class:
Azole Antifungal
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study of Treatments for Fungal Infections of the Mouth and Throat in HIV-Infected Patients Who Have Had Success With Itraconazole But Not With Fluconazole
Candidiasis, OralHIV Infections
A Randomized, Prospective, Double-Blind Study Comparing Fluconazole With Placebo for Primary and Secondary Prophylaxis of Mucosal Candidiasis in HIV-Infected Women
400 enrolled
CandidiasisCandidiasis, EsophagealHIV Infections
A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.
64 enrolled
Meningitis, CryptococcalHIV Infections
A Study to Assess the Effect of Concomitant Administration of Fluconazole on the Clinical Pharmacokinetics of Methadone
24 enrolled
CandidiasisHIV Infections
Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites
48 enrolled
Bacterial InfectionsMycosesHIV Infections
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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.