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 5h ago · AI intelligence enriched 1w 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)
Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
Meningitis, CryptococcalHIV Infections
A Randomized Double Blind Protocol Comparing Amphotericin B With Flucytosine to Amphotericin B Alone Followed by a Comparison of Fluconazole and Itraconazole in the Treatment of Acute Cryptococcal Meningitis
400 enrolled
Meningitis, CryptococcalHIV Infections
A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis
Meningitis, CryptococcalHIV Infections
An Open, Non-Comparative Study of Intravenous and Oral Fluconazole in the Treatment of Acute Cryptococcal Meningitis
Meningitis, CryptococcalHIV Infections
A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients With AIDS
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.