Fluconazole capsule — Competitive Intelligence Brief

Fluconazole capsule (Fluconazole capsule) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Triazole antifungal. Area: Infectious Disease.

phase 3 Triazole antifungal Fungal cytochrome P450 (lanosterol 14α-demethylase) Infectious Disease Small molecule

Target snapshot

Fluconazole capsule (Fluconazole capsule) — Jiangsu HengRui Medicine Co., Ltd.. Fluconazole inhibits fungal cytochrome P450-dependent lanosterol 14α-demethylase, disrupting ergosterol synthesis in the fungal cell membrane.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Fluconazole capsule TARGET	Fluconazole capsule	Jiangsu HengRui Medicine Co., Ltd.	phase 3	Triazole antifungal	Fungal cytochrome P450 (lanosterol 14α-demethylase)
Voriconazole high dose	Voriconazole high dose	Manjunath Prakash Pai	marketed	Triazole antifungal	Fungal cytochrome P450 lanosterol 14α-demethylase (CYP51)
fast itraconazole tablet	fast itraconazole tablet	University of Maryland, Baltimore	marketed	Triazole antifungal	Fungal cytochrome P450 lanosterol 14α-demethylase (CYP51)
Voriconazole clinical practice	Voriconazole clinical practice	Instituto de Investigación Hospital Universitario La Paz	marketed	Triazole antifungal	Fungal cytochrome P450 lanosterol 14α-demethylase (CYP51)
ORAL VORICONAZOLE and IV Amphotericin B	ORAL VORICONAZOLE and IV Amphotericin B	All India Institute of Medical Sciences	phase 3	Antifungal agents (triazole and polyene)	Fungal cytochrome P450 lanosterol 14α-demethylase (voriconazole); ergosterol (amphotericin B)
medium itraconazole tablet	medium itraconazole tablet	University of Maryland, Baltimore	marketed	Triazole antifungal	Fungal CYP51 (lanosterol 14α-demethylase)
Posaconazole Delayed Release Oral Tablet	Posaconazole Delayed Release Oral Tablet	Cedars-Sinai Medical Center	marketed	Triazole antifungal	Lanosterol 14α-demethylase (CYP51)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Triazole antifungal class)

1. University of Maryland, Baltimore · 3 drugs in this class
2. Manjunath Prakash Pai · 2 drugs in this class
3. Pfizer · 2 drugs in this class
4. Janssen Pharmaceutical K.K. · 1 drug in this class
5. Jiangsu HengRui Medicine Co., Ltd. · 1 drug in this class
6. Merck Sharp & Dohme LLC · 1 drug in this class
7. Seoul National University Hospital · 1 drug in this class
8. University of California, San Francisco · 1 drug in this class
9. University of Minnesota · 1 drug in this class
10. Bayer · 1 drug in this class