DABRAFENIB MESYLATE | N202806 | NOVARTIS PHARMACEUTICALS CORP
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Novartis Pharmaceuticals Corporation v. Apotex Inc. et al 4 patentsANDA 221036dabrafenib | D. Del. | 2026-02-06 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Rising Pharma Holdings, Inc. FDA-2025-P-7322 Rising Pharma Holdings, Inc. filed this suitability petition under section 502(j)(2)(C) of the FDC Act and 21 CFR § 314.93 requesting FDA approval to submit an ANDA for Dabrafenib Capsules 150 mg, a new strength that differs from the reference listed drug TAFINLAR (Dabrafenib) 75 mg capsules approve | Suitability | 2025-12-23 | Open | Rising Pharma Holdings |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7994185 | Jan 20, 2030PED: Jul 20, 2030 | PED | Yes | Yes | — | |
| 8415345 | Jan 20, 2030PED: Jul 20, 2030 | PED | Yes | Yes | — | |
| 8703781 | Oct 15, 2030PED: Apr 15, 2031 | PED | Yes | Yes | — | |
| 8952018 | Oct 15, 2030PED: Apr 15, 2031 | PED | — | — | — | |
| 9233956 | May 4, 2029PED: Nov 4, 2029 | PED | — | — | — | |
| 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, 2030 | Active |