Orange Book product · Brand (NDA)
JASCAYD
NERANDOMILAST
At a glance
Oct 07, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 07, 2025
9 mo ago
Today
Exclusivity ends · I-979
New indication exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
Patent 8754073 expires
Listed drug substance patent expiration.
Nov 26, 2029
in 3 yr 6 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Oct 07, 2030
in 4 yr 4 mo
Patent 8609670 expires
Listed drug substance patent expiration.
Aug 23, 2032
in 6 yr 3 mo
Exclusivity ends · ODE-546
Orphan-drug exclusivity (7 years)
Oct 07, 2032
in 6 yr 5 mo
Patent 9802954 expires
Listed method-of-use patent (U-4298) expiration.
Feb 19, 2034
in 7 yr 9 mo
Patent 11406638 expires
Listed method-of-use patent (U-4373) expiration.
Oct 22, 2038
in 12 yr 6 mo
Patent 11406638 expires
Listed method-of-use patent (U-4297) expiration.
Oct 22, 2038
in 12 yr 6 mo
Patent 11813266 expires
Listed method-of-use patent (U-4372) expiration.
Oct 22, 2038
in 12 yr 6 mo
Patent 11813266 expires
Listed method-of-use patent (U-4292) expiration.
Oct 22, 2038
in 12 yr 6 mo
Pharmaceutical detail
Active ingredient
NERANDOMILAST
Strength
9MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 218764
Product number
001
Marketing status
RX
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 (3)
- I-979New indication exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
- NCENew chemical entity exclusivity (5 years)
Oct 07, 2030
in 4 yr 4 mo
- ODE-546Orphan-drug exclusivity (7 years)
Oct 07, 2032
in 6 yr 5 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8754073 | Nov 26, 2029 | in 3 yr 6 mo | SubstanceProductU-4298 |
| 8609670 | Aug 23, 2032 | in 6 yr 3 mo | Substance |
| 9802954 | Feb 19, 2034 | in 7 yr 9 mo | U-4298 |
| 11406638 | Oct 22, 2038 | in 12 yr 6 mo | U-4373 |
| 11406638 | Oct 22, 2038 | in 12 yr 6 mo | U-4297 |
| 11813266 | Oct 22, 2038 | in 12 yr 6 mo | U-4372 |
| 11813266 | Oct 22, 2038 | in 12 yr 6 mo | U-4292 |

