Viewing data from:

KOMZIFTI

NDA

ZIFTOMENIB | N220305 | KURA ONCOLOGY INC

1 strength8 unique patents1 unique exclusivity

Patent Timeline

8 unique patents, 1 exclusivity by expiration date

Active (8)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

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2045

Today

Mar. 16, 2036

Mar. 16, 2036

Mar. 15, 2037

Jan. 26, 2037

Mar. 15, 2037

Sep. 6, 2038

Jul. 16, 2044

Jul. 16, 2044

NCE

Nov. 13, 2030

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML NCT07007312	Phase 3	Recruiting	Kura Oncology, Inc.	1,300	2025-09-26 → 2031-11
Expanded Access to Ziftomenib NCT05738538	—	AVAILABLE	Kura Oncology, Inc.	—	—

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 14, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG

RLD

8 patents1 exclusivity▴

CAPSULE;ORAL | Approved: Nov 13, 2025

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10077271	Mar 16, 2036	—	Yes	Yes	—	—
10174041	Mar 16, 2036	—	—	—		—
10781218	Mar 15, 2037	—	Yes	Yes	—	—
10869868	Jan 26, 2037	—	—	—		—
11673898	Mar 15, 2037	—	—	—		—
11944627	Sep 6, 2038	—	—	—		—
12410184	Jul 16, 2044	—	Yes	Yes		—
12521396	Jul 16, 2044	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
NCE	Nov 13, 2030	Active