siponimod · Novartis · NDA 209884
Mayzent
Earliest generic entry, as listed · earliest of 3 marketed strengths
23 Apr 2036
Blocked by patent: US 11944602, US 12533340. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11944602 | use U-3889 | 23 Apr 2036 |
| US 12533340 | use U-4407 | 23 Apr 2036 |
| US 12071402 | product | 5 Jan 2032 |
| US 8492441 | use U-2511 | 30 Nov 2030 |
| US 7939519 | substance, product | 27 Aug 2028 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- 25 Oct 2026Generic approved · 209884-0016 Mar 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209884 · 001 · RLD | tablet, oral | EQ 0.25MG BASE | 23 Apr 2036 |
| 209884 · 002 · RLD | tablet, oral | EQ 2MG BASE | 23 Apr 2036 |
| 209884 · 003 · RLD | tablet, oral | EQ 1MG BASE | 23 Apr 2036 |