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Luzu

(Luliconazole Cream 1%)

Small molecule

BBausch Health Americas, Inc.

0

Indications

4

Total Trials

1

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

4

Patents

Timeline

Expected Milestones

Q4 2026

Post-ApprovalNot yet recruiting

Pityriasis Versicolor

NCT07333170

Clinical

Trials by Indication[1]

Safety and Efficacy1 trial

Safety and Efficacy of Product 33525 (Luliconazole Cream 1%) in Pediatric Participants With Tinea Corporis

Completed·BBausch Health Americas, Inc.·Phase 4·NCT02767947·75 enrolled

Interaction1 trial

Study Evaluating the Drug Interaction Potential of Luliconazole Cream 1% in Participants With Tinea Pedis and Tinea Cruris

Completed·BBausch & Lomb Incorporated·Phase 4·NCT02394340·20 enrolled

Pityriasis Versicolor1 trial

Comparison of the Efficacy of Topical Luliconazole 2% Cream vs Topical Ketoconazole 1% Cream in the Treatment of Pityriasis Versicolor.

Not yet recruiting·PPAEC General Hospital, Islamabad·Phase 4·NCT07333170·86 enrolled

Tinea Pedis1 trial

Maximal Use of Luliconazole Cream 1% in Pediatric Participants With Moderate to Severe Tinea Pedis or Tinea Cruris

Completed·BBausch Health Americas, Inc.·Phase 4·NCT02767271·30 enrolled

Regulatory

FDA Approval Timeline[3]

Nov 14, 2013

LUZU

NDA NDA204153

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Luliconazole Cream 1%. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Luliconazole Cream 1% compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA204153). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Luzu. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Bausch Health Americas, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: BBausch Health Americas, Inc.

Patent Landscape[4]

Patent Cliff

Sep 6, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9012484Sep 6, 2033

9453006Sep 6, 2033

9199977Sep 6, 2033

8980931Apr 28, 2034

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