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 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DIFLUCAN (fluconazole) is an oral azole antifungal agent that works by inhibiting fungal cytochrome P450 2C19, disrupting ergosterol synthesis in fungal cell membranes. Approved in 1993, it is used to treat various fungal infections across multiple body systems. The drug has become a standard-of-care option for candidiasis and other fungal infections in both immunocompromised and immunocompetent patients.
$0.229MPart D
LOE ApproachingDeclining
As LOE approaches with minimal Part D spending, the brand team is likely contracting; career opportunities focus on generic transition management and niche positioning rather than growth expansion.
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)
Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)
500 enrolled
CandidiasisMycosesHIV Infections
Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites
48 enrolled
Bacterial InfectionsMycosesHIV Infections
Pilot Study to Determine the Feasibility of Fluconazole for Induction Treatment and Suppression of Relapse of Histoplasmosis in Patients With the Acquired Immunodeficiency Syndrome
90 enrolled
HIV InfectionsHistoplasmosis
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 Study of Fluconazole in the Prevention of Fungal Infections in HIV-Infected Patients Living in Areas Where Fungal Infections Are Common
MycosesHIV InfectionsCoccidioidomycosis
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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.