cliffwatch

ziftomenib · Kura · NDA 220305

Komzifti

Earliest generic entry, as listed
16 Jul 2044

Blocked by patent: US 12410184, US 12521396.

Listed patents · 8 unexpired

13 Orange Book listing rows for 8 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 12410184drug substance, drug product, use U-4347, U-434816 Jul 2044
US 12410184 listing rowdrug substance, drug product, use U-4347 · sets the listed date16 Jul 2044
US 12410184 listing rowdrug substance, drug product, use U-4348 · sets the listed date16 Jul 2044
US 12521396drug product · sets the listed date16 Jul 2044
US 11944627use U-4347, U-43496 Sep 2038
US 11944627 listing rowuse U-43476 Sep 2038
US 11944627 listing rowuse U-43496 Sep 2038
US 10781218drug substance, drug product15 Mar 2037
US 11673898use U-4350, U-435115 Mar 2037
US 11673898 listing rowuse U-435015 Mar 2037
US 11673898 listing rowuse U-435115 Mar 2037
US 10869868use U-4352, U-435326 Jan 2037
US 10869868 listing rowuse U-435226 Jan 2037
US 10869868 listing rowuse U-435326 Jan 2037
US 10077271drug substance, drug product16 Mar 2036
US 10174041use U-4350, U-435416 Mar 2036
US 10174041 listing rowuse U-435016 Mar 2036
US 10174041 listing rowuse U-435416 Mar 2036

Exclusivities · 1 unexpired

NCEnew chemical entity (5 years)13 Nov 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
220305 · 001 · RLDcapsule, oral200MG16 Jul 2044