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Sofdra

(Sofpironium Bromide, 15%)

Small molecule

BBotanix Pharmaceuticals

0

Indications

4

Total Trials

0

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

21

Patents

Clinical

Trials by Indication[1]

Hyperhidrosis4 trials

Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302)

Completed·BBotanix Pharmaceuticals·Phase 3·NCT03948646·351 enrolled

A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis

Completed·BBotanix Pharmaceuticals·Phase 3·NCT03627468·300 enrolled

Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)

Completed·BBotanix Pharmaceuticals·Phase 3·NCT03836287·350 enrolled

Show 1 more trial

A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis

Completed·BBotanix Pharmaceuticals·Phase 2·NCT03785587·21 enrolled

Regulatory

FDA Approval Timeline[3]

Jun 18, 2024

SOFDRA

NDA NDA217347

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Sofpironium Bromide, 15%. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sofpironium Bromide, 15% compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA217347). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Sofdra. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Botanix Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: BBotanix Pharmaceuticals

Patent Landscape[4]

Patent Cliff

Nov 13, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8628759Nov 13, 2026

8147809Mar 26, 2027

10383846Mar 14, 2034

9492429Mar 14, 2034

9895350Mar 14, 2034

16 more patents

9220707Mar 14, 2034

11026919May 22, 2034

10961191May 22, 2034

10959983May 22, 2034

10952990May 22, 2034

10947192May 22, 2034

12357609May 22, 2034

12156865May 22, 2034

12398102May 22, 2034

11084788May 22, 2034

11052067May 22, 2034

11034652May 22, 2034

11123325Jul 20, 2037

12703682May 22, 2040

11584715May 22, 2040

11566000May 22, 2040

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