Question 1

Is there a generic for Ziftomenib?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Ziftomenib. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Ziftomenib?

Accepted Answer

KOMZIFTI (NDA 220305, KURA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Ziftomenib?

Accepted Answer

The Orange Book lists 8 patents against Ziftomenib products, with the earliest listed expiry in 2036. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Ziftomenib have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Ziftomenib. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Ziftomenib are approved?

Accepted Answer

Ziftomenib is approved in the following dosage form: capsule.

Patent	Expires	In	Type
10174041	Mar 16, 2036	in 9 yr 11 mo	U-4350
10077271	Mar 16, 2036	in 9 yr 11 mo	SubstanceProduct
10869868	Jan 26, 2037	in 10 yr 9 mo	U-4352
11673898	Mar 15, 2037	in 10 yr 11 mo	U-4350
10781218	Mar 15, 2037	in 10 yr 11 mo	SubstanceProduct
11944627	Sep 06, 2038	in 12 yr 5 mo	U-4347
12410184	Jul 16, 2044	in 18 yr 4 mo	SubstanceProductU-4347
12521396	Jul 16, 2044	in 18 yr 4 mo	Product

Ziftomenib

Brand (NDA) products · capsule

Marketing exclusivity (1)

Listed patents (8)

Ziftomenib — frequently asked questions

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