Assyro AI

Orange Book product · Brand (NDA)

KOMZIFTI

ZIFTOMENIB

Brand (NDA)NDA 220305RX KURA

At a glance

Nov 13, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

13

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 13, 2025

    7 mo ago

  2. Today

  3. Exclusivity ends · NCE

    New chemical entity exclusivity (5 years)

    Nov 13, 2030

    in 4 yr 6 mo

  4. Patent 10077271 expires

    Listed drug substance patent expiration.

    Mar 16, 2036

    in 9 yr 11 mo

  5. Patent 10174041 expires

    Listed method-of-use patent (U-4350) expiration.

    Mar 16, 2036

    in 9 yr 11 mo

  6. Patent 10174041 expires

    Listed method-of-use patent (U-4354) expiration.

    Mar 16, 2036

    in 9 yr 11 mo

  7. Patent 10869868 expires

    Listed method-of-use patent (U-4352) expiration.

    Jan 26, 2037

    in 10 yr 9 mo

  8. Patent 10869868 expires

    Listed method-of-use patent (U-4353) expiration.

    Jan 26, 2037

    in 10 yr 9 mo

  9. Patent 10781218 expires

    Listed drug substance patent expiration.

    Mar 15, 2037

    in 10 yr 11 mo

  10. Patent 11673898 expires

    Listed method-of-use patent (U-4350) expiration.

    Mar 15, 2037

    in 10 yr 11 mo

  11. Patent 11673898 expires

    Listed method-of-use patent (U-4351) expiration.

    Mar 15, 2037

    in 10 yr 11 mo

  12. Patent 11944627 expires

    Listed method-of-use patent (U-4347) expiration.

    Sep 06, 2038

    in 12 yr 5 mo

  13. Patent 11944627 expires

    Listed method-of-use patent (U-4349) expiration.

    Sep 06, 2038

    in 12 yr 5 mo

  14. Patent 12410184 expires

    Listed drug substance patent expiration.

    Jul 16, 2044

    in 18 yr 4 mo

  15. Patent 12410184 expires

    Listed drug substance patent expiration.

    Jul 16, 2044

    in 18 yr 4 mo

  16. Patent 12521396 expires

    Listed drug product patent expiration.

    Jul 16, 2044

    in 18 yr 4 mo

Pharmaceutical detail

Active ingredient

ZIFTOMENIB

Strength

200MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 220305

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (1)

  • NCENew chemical entity exclusivity (5 years)

    Nov 13, 2030

    in 4 yr 6 mo

Listed patents (13)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10077271Mar 16, 2036in 9 yr 11 mo
SubstanceProduct
10174041Mar 16, 2036in 9 yr 11 mo
U-4350
10174041Mar 16, 2036in 9 yr 11 mo
U-4354
10869868Jan 26, 2037in 10 yr 9 mo
U-4352
10869868Jan 26, 2037in 10 yr 9 mo
U-4353
10781218Mar 15, 2037in 10 yr 11 mo
SubstanceProduct
11673898Mar 15, 2037in 10 yr 11 mo
U-4350
11673898Mar 15, 2037in 10 yr 11 mo
U-4351
11944627Sep 06, 2038in 12 yr 5 mo
U-4347
11944627Sep 06, 2038in 12 yr 5 mo
U-4349
12410184Jul 16, 2044in 18 yr 4 mo
SubstanceProductU-4347
12410184Jul 16, 2044in 18 yr 4 mo
SubstanceProductU-4348
12521396Jul 16, 2044in 18 yr 4 mo
Product
Agent CTA Background

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