Orange Book product · Brand (NDA)
KOMZIFTI
ZIFTOMENIB
At a glance
Nov 13, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
13
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 13, 2025
7 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Nov 13, 2030
in 4 yr 6 mo
Patent 10077271 expires
Listed drug substance patent expiration.
Mar 16, 2036
in 9 yr 11 mo
Patent 10174041 expires
Listed method-of-use patent (U-4350) expiration.
Mar 16, 2036
in 9 yr 11 mo
Patent 10174041 expires
Listed method-of-use patent (U-4354) expiration.
Mar 16, 2036
in 9 yr 11 mo
Patent 10869868 expires
Listed method-of-use patent (U-4352) expiration.
Jan 26, 2037
in 10 yr 9 mo
Patent 10869868 expires
Listed method-of-use patent (U-4353) expiration.
Jan 26, 2037
in 10 yr 9 mo
Patent 10781218 expires
Listed drug substance patent expiration.
Mar 15, 2037
in 10 yr 11 mo
Patent 11673898 expires
Listed method-of-use patent (U-4350) expiration.
Mar 15, 2037
in 10 yr 11 mo
Patent 11673898 expires
Listed method-of-use patent (U-4351) expiration.
Mar 15, 2037
in 10 yr 11 mo
Patent 11944627 expires
Listed method-of-use patent (U-4347) expiration.
Sep 06, 2038
in 12 yr 5 mo
Patent 11944627 expires
Listed method-of-use patent (U-4349) expiration.
Sep 06, 2038
in 12 yr 5 mo
Patent 12410184 expires
Listed drug substance patent expiration.
Jul 16, 2044
in 18 yr 4 mo
Patent 12410184 expires
Listed drug substance patent expiration.
Jul 16, 2044
in 18 yr 4 mo
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 familyThis 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)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10077271 | Mar 16, 2036 | in 9 yr 11 mo | SubstanceProduct |
| 10174041 | Mar 16, 2036 | in 9 yr 11 mo | U-4350 |
| 10174041 | Mar 16, 2036 | in 9 yr 11 mo | U-4354 |
| 10869868 | Jan 26, 2037 | in 10 yr 9 mo | U-4352 |
| 10869868 | Jan 26, 2037 | in 10 yr 9 mo | U-4353 |
| 10781218 | Mar 15, 2037 | in 10 yr 11 mo | SubstanceProduct |
| 11673898 | Mar 15, 2037 | in 10 yr 11 mo | U-4350 |
| 11673898 | Mar 15, 2037 | in 10 yr 11 mo | U-4351 |
| 11944627 | Sep 06, 2038 | in 12 yr 5 mo | U-4347 |
| 11944627 | Sep 06, 2038 | in 12 yr 5 mo | U-4349 |
| 12410184 | Jul 16, 2044 | in 18 yr 4 mo | SubstanceProductU-4347 |
| 12410184 | Jul 16, 2044 | in 18 yr 4 mo | SubstanceProductU-4348 |
| 12521396 | Jul 16, 2044 | in 18 yr 4 mo | Product |

