Details for New Drug Application (NDA): 220305

NDA 220305 describes KOMZIFTI, which is a drug marketed by Kura and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the KOMZIFTI profile page.

The generic ingredient in KOMZIFTI is ziftomenib. One supplier is listed for this compound. Additional details are available on the ziftomenib profile page.

Summary for 220305

Tradename:	KOMZIFTI
Applicant:	Kura
Ingredient:	ziftomenib
Patents:	8

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 220305

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 220305

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
KOMZIFTI	ziftomenib	CAPSULE;ORAL	220305	NDA	Kura Oncology, Inc.	84696-200	84696-200-90	90 CAPSULE in 1 BOTTLE (84696-200-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Nov 13, 2025	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Nov 13, 2030
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:	10,077,271	Patent Expiration:	Mar 16, 2036	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	10,174,041	Patent Expiration:	Mar 16, 2036	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF INHIBITING MENIN INTERACTION

Complete Access Available with Subscription