cliffwatch

sofpironium bromide · Botanix Sb · NDA 217347

Sofdra

Earliest generic entry, as listed
22 May 2040

Blocked by patent: US 11566000, US 11584715, US 12703682.

Listed patents · 21 unexpired

PatentClaimsExpires
US 11566000substance, product22 May 2040
US 11584715substance, product22 May 2040
US 12703682substance, product22 May 2040
US 11123325product, use U-239820 Jul 2037
US 10947192use U-239822 May 2034
US 10952990use U-239822 May 2034
US 10959983use U-239822 May 2034
US 10961191use U-239822 May 2034
US 11026919product, use U-239822 May 2034
US 11034652product, use U-239822 May 2034
US 11052067product, use U-239822 May 2034
US 11084788product, use U-239822 May 2034
US 12156865product, use U-239822 May 2034
US 12357609product, use U-239822 May 2034
US 12398102product, use U-239822 May 2034
US 10383846use U-239814 Mar 2034
US 9220707use U-239814 Mar 2034
US 9492429product, use U-239814 Mar 2034
US 9895350use U-239814 Mar 2034
US 8628759use U-239813 Nov 2027
US 8147809substance, product26 Mar 2027

Exclusivities · 1 unexpired

NCEnew chemical entity (5 years)20 Jun 2029

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 1

NDA · productFormStrengthListed expiry
217347 · 001 · RLDgel, metered, topicalEQ 12.45% BASE (EQ 72MG BASE/ACTUATION)22 May 2040