Orange Book product · Brand (NDA)
PONVORY
PONESIMOD
At a glance
Mar 18, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 18, 2021
5 yr 4 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Mar 18, 2026
3 mo ago
Today
Patent RE43728 expires
Listed drug substance patent expiration.
Nov 16, 2029
in 3 yr 6 mo
Patent 9062014 expires
Listed drug substance patent expiration.
May 06, 2032
in 6 yr
Patent 10220023 expires
Listed method-of-use patent (U-3103) expiration.
Dec 10, 2035
in 9 yr 7 mo
Patent 12336980 expires
Listed method-of-use patent (U-3103) expiration.
Dec 10, 2035
in 9 yr 7 mo
Patent 11951097 expires
Listed method-of-use patent (U-3891) expiration.
Oct 10, 2042
in 16 yr 7 mo
Pharmaceutical detail
Active ingredient
PONESIMOD
Strength
2MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 213498
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)
Mar 18, 2026
3 mo ago
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE43728 | Nov 16, 2029 | in 3 yr 6 mo | SubstanceProduct |
| 9062014 | May 06, 2032 | in 6 yr | SubstanceProductU-2774 |
| 10220023 | Dec 10, 2035 | in 9 yr 7 mo | U-3103 |
| 12336980 | Dec 10, 2035 | in 9 yr 7 mo | U-3103 |
| 11951097 | Oct 10, 2042 | in 16 yr 7 mo | U-3891 |
