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Winlevi

(Clascoterone)

Small molecule

0

Indications

1

Total Trials

1

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

8

Patents

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Efficacy and Safety

NCT06403501

Clinical

Trials by Indication[1]

Efficacy and Safety1 trial

Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris

Recruiting·ZZhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.·Phase 3·NCT06403501·692 enrolled

Regulatory

FDA Approval Timeline[3]

Aug 26, 2020

WINLEVI

NDA NDA213433

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for Clascoterone. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Clascoterone compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA213433). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Winlevi. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Sun Pharma company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: Sun Pharma

Patent Landscape[4]

Patent Cliff

Jan 12, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8143240Jan 12, 2027

12337002Jul 24, 2028

9486458Jul 24, 2028

11938141Jul 24, 2028

10159682Aug 14, 2028

3 more patents

11207332Nov 20, 2028

9433628Feb 28, 2029

8785427Jul 25, 2030

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