SIPONIMOD | N209884 | NOVARTIS PHARMACEUTICALS CORP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
NOVARTIS PHARMACEUTICALS CORPORATION et al v. DR. REDDY'S LABORATORIES, LTD. et al 2 patentsANDA 218393siponimod | D.N.J. | 2025-05-15 | Terminated 2025-07-29 | — |
Novartis Pharmaceuticals Corporation et al v. Lupin Limited et al 2 patentsANDA 218453siponimod | D. Del. | 2025-05-09 | Terminated 2025-12-02 | — |
Novartis Pharmaceuticals Corporation et al v. Cipla Limited et al 3 patentsANDA 218228siponimod | D. Del. | 2025-02-14 | Terminated 2025-10-06 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Kaylin Bower FDA-2026-P-0775 · 2 docket documents Kaylin Bower filed this citizen petition with the FDA on January 24, 2026, requesting that the agency correct or remove misleading statements in FDA approval tables for multiple sclerosis drugs including Kesimpta, Aubagio, Ponvory, Gilenya, Mayzent, and Zeposia that present relative risk reductions | Other | 2026-01-27 | Open | Kaylin Bower |
Citizen Petition from Novartis Pharmaceuticals Corporation FDA-2023-P-0793 · 37 docket documents Novartis Pharmaceuticals Corporation filed this citizen petition on March 3, 2023, requesting that the FDA require any ANDA or 505(b)(2) NDA referencing MAYZENT (siponimod fumaric acid) to include the approved dosage titration regimen and an appropriate patent certification, and to refrain from appr | 505(q) | 2023-03-06 | Open | Novartis Pharmaceuticals Corporation |
Source: Regulations.gov. FDA citizen petitions matched by application number.