sonrotoclax · Beone Medicines Usa · NDA 220711

Beqalzi

Earliest generic entry, as listed · earliest of 4 marketed strengths
29 Apr 2039

Blocked by patent: US 11420968.

Listed patents · 1 unexpired

PatentClaimsExpires
US 11420968drug substance, drug product · sets the listed date29 Apr 2039

Exclusivities · 1 unexpired

NCEnew chemical entity (5 years)13 May 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 · 4

NDA · productFormStrengthListed expiry
220711 · 001 · RLDtablet, oral1MG29 Apr 2039
220711 · 002 · RLDtablet, oral5MG29 Apr 2039
220711 · 003 · RLDtablet, oral20MG29 Apr 2039
220711 · 004 · RLDtablet, oral80MG29 Apr 2039