small molecule

SOFDRA

SOFPIRONIUM BROMIDE

Loss of exclusivityMay 2040latest FDA-listed patent expiry

CompanyBOTANIX SB INC

Drug detail

Brand name	SOFDRA
Active ingredient	SOFPIRONIUM BROMIDE
Strength	EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)
Dosage form	GEL, METERED
Route	TOPICAL
Modality	Small molecule
FDA approval	June 2024
Marketing status	RX

Listed patents

Patent	Expires	Type
11566000	May 2040	substance, product
11584715	May 2040	substance, product
11123325	July 2037	product
11084788	May 2034	product
11052067	May 2034	product
11034652	May 2034	product
11026919	May 2034	product
10961191	May 2034	use U-2398
10959983	May 2034	use U-2398
10952990	May 2034	use U-2398
10947192	May 2034	use U-2398
12357609	May 2034	product
12156865	May 2034	product
12398102	May 2034	product
9492429	March 2034	product
9895350	March 2034	use U-2398
9220707	March 2034	use U-2398
10383846	March 2034	use U-2398
8147809	March 2027	substance, product
8628759	November 2026	use U-2398

Regulatory exclusivity

Code	Expires
NCE	June 2029

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.