Orange Book product · Brand (NDA)
NEREUS
TRADIPITANT
At a glance
Dec 30, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 30, 2025
6 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Dec 30, 2030
in 4 yr 7 mo
Patent 10772880 expires
Listed method-of-use patent (U-4396) expiration.
Mar 04, 2036
in 9 yr 10 mo
Patent 10821099 expires
Listed method-of-use patent (U-4396) expiration.
Mar 04, 2036
in 9 yr 10 mo
Patent 11324735 expires
Listed method-of-use patent (U-4396) expiration.
Mar 04, 2036
in 9 yr 10 mo
Patent 12318375 expires
Listed method-of-use patent (U-4396) expiration.
Aug 09, 2036
in 10 yr 3 mo
Pharmaceutical detail
Active ingredient
TRADIPITANT
Strength
85MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 220152
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)
Dec 30, 2030
in 4 yr 7 mo
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10772880 | Mar 04, 2036 | in 9 yr 10 mo | U-4396 |
| 10821099 | Mar 04, 2036 | in 9 yr 10 mo | U-4396 |
| 11324735 | Mar 04, 2036 | in 9 yr 10 mo | U-4396 |
| 12318375 | Aug 09, 2036 | in 10 yr 3 mo | U-4396 |
