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 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)
Non-Comparative Study of Fluconazole in Patients With Serious Mycoses and Who Cannot Be Treated With Conventional Antifungal Therapy
CandidiasisMycosesHIV Infections
A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections
MycosesHIV Infections
A Comparison of Fluconazole and Amphotericin B in the Treatment of Cryptococcal Meningitis
Meningitis, CryptococcalHIV Infections
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
Safety and Effectiveness of Giving L-743,872 to Patients With Thrush That Has Not Been Cured With Fluconazole
70 enrolled
Candidiasis, OralHIV 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.