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Sofdra · pharmadog

pharmadog
drugs
Sofdra

drug

patient view →

sofpironium bromide

Marketedupdated 2mo ago

by Botanix Pharmaceuticals Ltd

Approved

community read0 votes

all catalysts(0)

nothing on the calendar yet

News(0)

no news has mentioned this drug yet

brand

Sofdra

generic

sofpironium bromide

indication

Axillary Hyperhidrosis

phase

marketed

Data sources

ClinicalTrials.gov

last refreshed 30m ago

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Patent cliff

source: FDA Orange Book

first barrier falls

Nov 13, 2026

129 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (20)

May 22, 2040compositionUS 11566000
May 22, 2040compositionUS 11584715
Jul 20, 2037formulationUS 11123325
May 22, 2034method-of-use (U-2398)US 10947192
May 22, 2034method-of-use (U-2398)US 10952990
May 22, 2034method-of-use (U-2398)US 10959983
May 22, 2034method-of-use (U-2398)US 10961191
May 22, 2034formulationUS 11026919
May 22, 2034formulationUS 11034652
May 22, 2034formulationUS 11052067
May 22, 2034formulationUS 11084788
May 22, 2034formulationUS 12156865
May 22, 2034formulationUS 12357609
May 22, 2034formulationUS 12398102
Mar 14, 2034method-of-use (U-2398)US 10383846
Mar 14, 2034method-of-use (U-2398)US 9220707
Mar 14, 2034formulationUS 9492429
Mar 14, 2034method-of-use (U-2398)US 9895350
Mar 26, 2027compositionUS 8147809262d
Nov 13, 2026method-of-use (U-2398)US 8628759129d

FDA exclusivities (1)

Jun 20, 2029NCENew Chemical Entity (5y)3.0y

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Trials studying sofpironium bromide

phase3Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)completedn=350
phase3Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302)completedn=351
phase3A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosiscompletedn=300