deucravacitinib · Bristol · NDA 214958

Sotyktu

Earliest generic entry, as listed
11 Feb 2043

Blocked by patent: US 12521390, US 12521390.

Listed patents · 8 unexpired

PatentClaimsExpires
US 12521390product, use U-445111 Feb 2043
US 12521390product, use U-343411 Feb 2043
US 12734169product, use U-343418 Sep 2040
US 12734169product, use U-445218 Sep 2040
US 10000480substance, product7 Nov 2033
US 11021475use U-34347 Nov 2033
US RE47929substance, product, use U-34347 Nov 2033
US RE47929substance, product, use U-44527 Nov 2033

Exclusivities · 2 unexpired

I-986new indication (3 years)6 Mar 2029
NCEnew chemical entity (5 years)9 Sep 2027

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
214958 · 001 · RLDtablet, oral6MG11 Feb 2043