TERIFLUNOMIDE | N202992 | SANOFI AVENTIS US LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2019-10-17 | Terminated 2020-05-13 | — | |
| D. Del. | 2017-01-25 | Terminated 2017-04-28 | — | |
| D. Del. | 2017-01-12 | Terminated 2017-04-12 | — | |
| D. Del. | 2017-01-12 | Terminated 2017-10-11 | — | |
| D. Del. | 2017-01-11 | Terminated 2018-01-02 | — | |
| D. Del. | 2017-01-11 | Terminated 2017-03-10 | — | |
Sanofi-Aventis U.S. LLC et al v. Mylan Pharmaceuticals Inc. et al 3 patentsANDA 209702teriflunomide | D. Del. | 2017-01-10 | Terminated 2018-01-02 | — |
| D. Del. | 2017-01-10 | Terminated 2017-09-27 | — | |
| D. Del. | 2017-01-05 | Terminated 2017-10-30 | — | |
| D. Del. | 2017-01-05 | Terminated 2017-11-06 | — | |
Sanofi-Aventis U.S. LLC et al v. IMPAX Laboratories, Inc. 2 patentsANDA 209677teriflunomide | D. Del. | 2017-01-03 | Terminated 2017-04-21 | — |
| D. Del. | 2017-01-03 | Terminated 2017-06-23 | — | |
Sanofi-Aventis U.S. LLC et al v. Alvogen Pine Brook LLC 2 patentsANDA 209555teriflunomide | D. Del. | 2016-12-22 | Terminated 2018-01-02 | — |
Sanofi-Aventis U.S. LLC et al v. Cadila Healthcare Limited et al 2 patentsANDA 209549teriflunomide | D. Del. | 2016-12-22 | Terminated 2018-01-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Kaylin Bower FDA-2026-P-1223 · 12 docket documents Kaylin Bower filed this citizen petition requesting that the FDA revise the labeling for Aubagio (teriflunomide) to clearly disclose that the statistically significant reduction in disability progression demonstrated in the pivotal TEMSO trial (Study 1) was observed only in the Eastern European tria | 505(q) | 2026-02-05 | Open | Kaylin Bower |
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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.