iberdomide hydrochloride · Bristol Myers Squibb · NDA 221075

Zenbexus

Earliest generic entry, as listed · earliest of 2 marketed strengths
30 Sep 2039

Blocked by patent: US 11529339. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 7 unexpired

PatentClaimsExpires
US 11529339use U-459830 Sep 2039
US RE49647product7 Oct 2034
US RE50917use U-45987 Oct 2034
US 9221788substance25 Sep 2033
US 9629849use U-45988 Aug 2033
US 8518972substance, product5 Jun 2031
US 9828361substance, product10 Feb 2031

Exclusivities · 1 unexpired

NCEnew chemical entity (5 years)13 Aug 2031

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
221075 · 001 · RLDcapsule, oralEQ 0.75MG BASE30 Sep 2039
221075 · 002 · RLDcapsule, oralEQ 1MG BASE30 Sep 2039