siponimod · Novartis · NDA 209884
Mayzent
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.
FDA has approved 1 generic application (ANDA) for Mayzent, though its earliest generic-entry date is 23 Apr 2036 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11944602 | use U-3889 · sets the listed date | 23 Apr 2036 |
| US 12533340 | use U-4407 · sets the listed date | 23 Apr 2036 |
| US 12071402 | drug product | 5 Jan 2032 |
| US 8492441 | use U-2511 | 30 Nov 2030 |
| US 7939519 | drug substance, drug 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
- Generic approved · ANDA 218459, Aurobindo Pharma Ltd · 209884-001Approved 6 Mar 2026Detected 25 Oct 2026Historical import
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 |