gilteritinib fumarate · Astellas · NDA 211349

Xospata

Earliest generic entry, as listed
1 Jul 2036

Blocked by patent: US 10786500, US 11938130, US 11938131, US 11938132, US 11938133, US 11944620.

Listed patents · 8 unexpired

PatentClaimsExpires
US 10786500drug product · sets the listed date1 Jul 2036
US 11938130drug product · sets the listed date1 Jul 2036
US 11938131drug product · sets the listed date1 Jul 2036
US 11938132drug product · sets the listed date1 Jul 2036
US 11938133drug product · sets the listed date1 Jul 2036
US 11944620drug product · sets the listed date1 Jul 2036
US 8969336drug substance, drug product28 Nov 2032
US 9487491use U-245628 Jul 2030

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
211349 · 001 · RLDtablet, oralEQ 40MG BASE1 Jul 2036