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Ketoconazole tablet — Competitive Intelligence Brief

Ketoconazole tablet (Ketoconazole tablet) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Azole antifungal. Area: Infectious Disease.

phase 2 Azole antifungal Lanosterol 14α-demethylase Infectious Disease Small molecule Live · refreshed every 30 min

Target snapshot

Ketoconazole tablet (Ketoconazole tablet) — Purdue Pharma LP. Ketoconazole is a broad-spectrum antifungal agent that inhibits the synthesis of ergosterol, a vital component of fungal cell membranes, by blocking the cytochrome P450-dependent enzyme lanosterol 14α-demethylase.

Comparator set (6 drugs)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Ketoconazole tablet TARGET Ketoconazole tablet Purdue Pharma LP phase 2 Azole antifungal Lanosterol 14α-demethylase
Loceryl NL 12 weeks Loceryl NL 12 weeks Galderma R&D marketed Allylamine antifungal Lanosterol 14α-demethylase (CYP51)
Topical Clotrimazole cream Topical Clotrimazole cream Hayat Abad Medical Complex, Peshawar marketed Imidazole antifungal Fungal lanosterol 14α-demethylase (CYP51)
Terconazole Vaginal Suppository Terconazole Vaginal Suppository Hatem AbuHashim marketed Azole antifungal Lanosterol 14α-demethylase (CYP51)
Topical ketoconazole 2% cream Topical ketoconazole 2% cream PAEC General Hospital, Islamabad marketed Imidazole antifungal Fungal cytochrome P450 (CYP51 / lanosterol 14α-demethylase)
Topical Sertaconazole 2% Topical Sertaconazole 2% Jinnah Postgraduate Medical Centre marketed Imidazole antifungal Lanosterol 14α-demethylase (CYP51)
Canesten® Canesten® Ache Laboratorios Farmaceuticos S.A. marketed Imidazole 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 (Azole antifungal class)

  1. Pfizer · 3 drugs in this class
  2. Elion Therapeutics, Inc. · 1 drug in this class
  3. Hadassah Medical Organization · 1 drug in this class
  4. Hatem AbuHashim · 1 drug in this class
  5. Janssen Pharmaceutical K.K. · 1 drug in this class
  6. Jiangsu Aosaikang Pharmaceutical Co., Ltd. · 1 drug in this class
  7. Military Hospital of Tunis · 1 drug in this class
  8. Mycovia Pharmaceuticals Inc. · 1 drug in this class
  9. Nuvation Bio Inc. · 1 drug in this class
  10. Purdue Pharma LP · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Ketoconazole tablet — Competitive Intelligence Brief. https://druglandscape.com/ci/ketoconazole-tablet. Accessed 2026-05-13.

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