mavorixafor · X4 Pharms · NDA 218709

Xolremdi

Earliest generic entry, as listed
11 Dec 2038

Blocked by patent: US 10548889, US 11045461, US 12115156.

Listed patents · 6 unexpired

PatentClaimsExpires
US 10548889product11 Dec 2038
US 11045461product11 Dec 2038
US 12115156product11 Dec 2038
US 10610527use U-393222 Dec 2036
US 11219621use U-393222 Dec 2036
US 10953003product14 Dec 2036

Exclusivities · 2 unexpired

ODE-480orphan drug (7 years)26 Apr 2031
NCEnew chemical entity (5 years)26 Apr 2029

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
218709 · 001 · RLDcapsule, oral100MG11 Dec 2038