TRAMETINIB DIMETHYL SULFOXIDE | N204114 | NOVARTIS PHARMACEUTICALS CORP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Novartis Pharmaceuticals Corporation v. Apotex Inc. et al 4 patentsANDA 220471trametinib dimethyl sulfoxide | D. Del. | 2025-10-30 | Active | — |
Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals, Inc. et al 4 patentsANDA 220040trametinib dimethyl sulfoxide | D. Del. | 2025-07-24 | Terminated 2025-11-25 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Apotex Inc. FDA-2023-P-1795 Apotex Inc. filed this petition on May 4, 2023, requesting that the FDA determine whether MEKINIST (Trametinib Dimethyl Sulfoxide) Tablets, 1 mg, NDA 204114 held by Novartis Pharmaceuticals Corp, has been voluntarily withdrawn from sale for reasons of safety or efficacy pursuant to 21 CFR 314.161, a | 505(q) | 2023-05-05 | Withdrawn | Apotex Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7378423 | May 29, 2027PED: Nov 29, 2027 | PED | Yes | Yes | — | — |
| 8580304 | Jan 28, 2032PED: Jul 28, 2032 | PED | — | Yes | — | — |
| 8703781 | Oct 15, 2030PED: Apr 15, 2031 | PED | Yes | Yes | — | |
| 8952018 | Oct 15, 2030PED: Apr 15, 2031 | PED | — | — | — | |
| 9155706 | Jan 28, 2032PED: Jul 28, 2032 | PED | — | Yes | — | — |
| 9271941 | Jan 28, 2032PED: Jul 28, 2032 | PED | — | Yes | — | — |
| 9399021 | Jan 28, 2032PED: Jul 28, 2032 | PED | — | Yes | — | — |
| 10869869 | Aug 30, 2033PED: Feb 28, 2034 | PED | — | — | — |
| Code | Date | Status |
|---|---|---|
| I-908 | Mar 16, 2026 | Expired |
| ODE-428 | Mar 16, 2030 | Active |
| PED | Sep 16, 2026 | < 1 year |