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 Yesterday
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 a broad spectrum of mycoses including candidiasis, cryptococcosis, coccidioidomycosis, and histoplasmosis, with particular utility in immunocompromised patients including those with HIV infection. The drug is available as an oral suspension, enabling flexible dosing across pediatric and adult populations.
$0.229MPart D
LOE ApproachingDeclining
Product approaching loss of exclusivity with modest Part D spending; brand team likely focused on cost-containment and niche indication management rather than growth initiatives.
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 Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections
MycosesHIV Infections
An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
Candidiasis, OralHIV Infections
A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients With AIDS
Meningitis, CryptococcalHIV Infections
Pilot Study of Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
Meningitis, CryptococcalHIV Infections
A Pilot Study of Fluconazole Plus Flucytosine for the Treatment of AIDS Patients With Acute Cryptococcal Meningitis.
64 enrolled
Meningitis, CryptococcalHIV Infections
Worked on DIFLUCAN at Pfizer? Share your interview experience or compensation data (+7 days Pro)
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.