taletrectinib adipate · Nuvation · NDA 219713

Ibtrozi

Earliest generic entry, as listed
3 Jun 2033

Blocked by patent: US 9187489, US 9751887.

Listed patents · 2 unexpired

PatentClaimsExpires
US 9187489substance, product, use U-42073 Jun 2033
US 9751887substance, product, use U-42073 Jun 2033

Exclusivities · 2 unexpired

ODE-544orphan drug (7 years)11 Jun 2032
NCEnew chemical entity (5 years)11 Jun 2030

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
219713 · 001 · RLDcapsule, oralEQ 200MG BASE3 Jun 2033