Orange Book product · Brand (NDA)
VELSIPITY
ETRASIMOD ARGININE
At a glance
Oct 12, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 12, 2023
2 yr 9 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Oct 12, 2028
in 2 yr 4 mo
Patent 9126932 expires
Listed method-of-use patent (U-3732) expiration.
Jul 22, 2029
in 3 yr 2 mo
Patent 8580841 expires
Listed drug substance patent expiration.
Mar 05, 2030
in 3 yr 9 mo
Patent 11007175 expires
Listed method-of-use patent (U-3730) expiration.
Jan 06, 2036
in 9 yr 8 mo
Patent 12156866 expires
Listed method-of-use patent (U-4047) expiration.
Jan 06, 2036
in 9 yr 8 mo
Patent 12377071 expires
Listed method-of-use patent (U-4255) expiration.
Jan 06, 2036
in 9 yr 8 mo
Patent 10301262 expires
Listed drug substance patent expiration.
Jun 21, 2036
in 10 yr 2 mo
Patent 10676435 expires
Listed method-of-use patent (U-3731) expiration.
Jun 21, 2036
in 10 yr 2 mo
Patent 11091435 expires
Listed drug substance patent expiration.
Jun 21, 2036
in 10 yr 2 mo
Patent 11884626 expires
Listed method-of-use patent (U-3731) expiration.
Jun 21, 2036
in 10 yr 2 mo
Pharmaceutical detail
Active ingredient
ETRASIMOD ARGININE
Strength
EQ 2MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 216956
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)
Oct 12, 2028
in 2 yr 4 mo
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9126932 | Jul 22, 2029 | in 3 yr 2 mo | U-3732 |
| 8580841 | Mar 05, 2030 | in 3 yr 9 mo | SubstanceProduct |
| 11007175 | Jan 06, 2036 | in 9 yr 8 mo | U-3730 |
| 12156866 | Jan 06, 2036 | in 9 yr 8 mo | U-4047 |
| 12377071 | Jan 06, 2036 | in 9 yr 8 mo | U-4255 |
| 10301262 | Jun 21, 2036 | in 10 yr 2 mo | SubstanceProduct |
| 10676435 | Jun 21, 2036 | in 10 yr 2 mo | U-3731 |
| 11091435 | Jun 21, 2036 | in 10 yr 2 mo | SubstanceProduct |
| 11884626 | Jun 21, 2036 | in 10 yr 2 mo | U-3731 |

