cliffwatch

brensocatib · Insmed Inc · NDA 217673

Brinsupri

Earliest generic entry, as listed · earliest of 2 marketed strengths
21 Feb 2040

Blocked by patent: US 12059424.

Listed patents · 14 unexpired

PatentClaimsExpires
US 12059424drug product · sets the listed date21 Feb 2040
US 12201638drug product1 Mar 2039
US 9522894drug substance12 Mar 2035
US 10287258drug substance, use U-425721 Jan 2035
US 10669245drug substance, use U-425721 Jan 2035
US 11655221drug product, use U-425721 Jan 2035
US 11655222drug substance, use U-425721 Jan 2035
US 11655223drug substance, use U-425721 Jan 2035
US 11655224drug product, use U-425721 Jan 2035
US 11673871drug product, use U-425721 Jan 2035
US 11773069drug product, use U-425721 Jan 2035
US 11814359drug substance, use U-425721 Jan 2035
US 12054465drug substance, use U-425721 Jan 2035
US 9815805use U-425721 Jan 2035

Exclusivities · 1 unexpired

NCEnew chemical entity (5 years)12 Aug 2030

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 · 2

NDA · productFormStrengthListed expiry
217673 · 001 · RLDtablet, oral10MG21 Feb 2040
217673 · 002 · RLDtablet, oral25MG21 Feb 2040