Orange Book product · Brand (NDA)
MAYZENT
SIPONIMOD
At a glance
Mar 26, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 26, 2019
7 yr 4 mo ago
Today
Patent 7939519 expires
Listed drug substance patent expiration.
Aug 27, 2028
in 2 yr 3 mo
Patent 8492441 expires
Listed method-of-use patent (U-2511) expiration.
Nov 30, 2030
in 4 yr 6 mo
Patent 12071402 expires
Listed drug product patent expiration.
Jan 05, 2032
in 5 yr 8 mo
Patent 11944602 expires
Listed method-of-use patent (U-3889) expiration.
Apr 23, 2036
in 10 yr
Patent 12533340 expires
Listed method-of-use patent (U-4407) expiration.
Apr 23, 2036
in 10 yr
Pharmaceutical detail
Active ingredient
SIPONIMOD
Strength
EQ 0.25MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 209884
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.
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7939519 | Aug 27, 2028 | in 2 yr 3 mo | SubstanceProduct |
| 8492441 | Nov 30, 2030 | in 4 yr 6 mo | U-2511 |
| 12071402 | Jan 05, 2032 | in 5 yr 8 mo | Product |
| 11944602 | Apr 23, 2036 | in 10 yr | U-3889 |
| 12533340 | Apr 23, 2036 | in 10 yr | U-4407 |
