FDA Orange Book · active-ingredient family
Siponimod
Siponimod is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MAYZENT · NDA 209884
1
Brand (NDA)
2
Generics (ANDA)
5
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MAYZENTRLD×3 | NOVARTIS | NDA 209884 | — | Mar 26, 2019 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SIPONIMOD×3 | AUROBINDO PHARMA LTD | ANDA 218459 | — | Mar 06, 2026 | |
| SIPONIMOD×3 | RICONPHARMA LLC | ANDA 218444 | — | Apr 22, 2025 |
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 |
| 12533340 | Apr 23, 2036 | in 10 yr | U-4407 |
| 11944602 | Apr 23, 2036 | in 10 yr | U-3889 |
Siponimod — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
