fedratinib hydrochloride · Bristol-Myers · NDA 212327

Inrebic

Earliest generic entry, as listed
24 Sep 2039

Blocked by patent: US 11400092. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 5 unexpired

PatentClaimsExpires
US 11400092use U-340924 Sep 2039
US 10391094product, use U-26074 Jun 2032
US 7528143substance, product16 Nov 2031
US 8138199use U-260730 Jun 2028
US 7825246substance16 Dec 2026

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

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
212327 · 001 · RLDcapsule, oralEQ 100MG BASE24 Sep 2039
Expired or delisted (1)
  • ODE-259 · 16 Aug 2026