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  1. pharmadog
  2. ›drugs
  3. ›Sofdra
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sofpironium bromide

Marketedupdated 3mo ago
by Botanix Pharmaceuticals Ltd
Approved
community read0 votes

all catalysts(0)

nothing on the calendar yet

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

Patent cliff

source: FDA Orange Book
first barrier falls
Nov 13, 2026
91 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 8147809224d
  • Nov 13, 2026method-of-use (U-2398)US 862875991d

FDA exclusivities (1)

  • Jun 20, 2029NCENew Chemical Entity (5y)2.9y

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 44m ago
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