Orange Book product · Brand (NDA)
EXKIVITY
MOBOCERTINIB SUCCINATE
At a glance
Sep 15, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 15, 2021
4 yr 10 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Sep 15, 2026
in 3 mo
Exclusivity ends · ODE-374
Orphan-drug exclusivity (7 years)
Sep 15, 2028
in 2 yr 3 mo
Patent 10227342 expires
Listed drug substance patent expiration.
May 13, 2035
in 9 yr
Patent 9796712 expires
Listed drug substance patent expiration.
May 13, 2035
in 9 yr
Pharmaceutical detail
Active ingredient
MOBOCERTINIB SUCCINATE
Strength
EQ 40MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 215310
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 (2)
- NCENew chemical entity exclusivity (5 years)
Sep 15, 2026
in 3 mo
- ODE-374Orphan-drug exclusivity (7 years)
Sep 15, 2028
in 2 yr 3 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10227342 | May 13, 2035 | in 9 yr | SubstanceProductU-3220 |
| 9796712 | May 13, 2035 | in 9 yr | SubstanceProduct |
