nilotinib tartrate · Azurity · NDA 219293

Danziten

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

Blocked by patent: US 10874671, US 11793809, US 12403140, US 12629369.

Listed patents · 4 unexpired

PatentClaimsExpires
US 10874671drug product · sets the listed date18 Feb 2040
US 11793809drug product · sets the listed date18 Feb 2040
US 12403140drug product · sets the listed date18 Feb 2040
US 12629369drug product · sets the listed date18 Feb 2040

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 · 2

NDA · productFormStrengthListed expiry
219293 · 001 · RLDtablet, oralEQ 71MG BASE18 Feb 2040
219293 · 002 · RLDtablet, oralEQ 95MG BASE18 Feb 2040