OXCARBAZEPINE | N202810 | SUPERNUS PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Supernus Pharmaceuticals, Inc. v. Ajanta Pharma Limited 10 patentsANDA 217659oxcarbazepine | D. Del. | 2022-10-28 | Terminated 2024-01-18 | — |
| D.N.J. | 2022-01-24 | Terminated 2022-08-01 | — | |
| D.N.J. | 2020-06-26 | Terminated 2023-06-27 | — | |
| D.N.J. | 2015-04-07 | Terminated 2016-05-04 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Supernus Pharmaceuticals (Ropes and Gray, LLP) FDA-2015-P-2830 Supernus Pharmaceuticals filed this citizen petition pursuant to Section 505 of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 10.30 requesting that FDA establish specific bioequivalence parameters, including partial area under the curve measurements at 0-T and T-t with 90-125% confidence | 505(q) | 2015-08-10 | Denied | Supernus Pharmaceuticals (Ropes and Gray |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7722898 | Apr 13, 2027 | — | — | Yes | — | — |
| 7910131 | Apr 13, 2027 | — | — | — | — | |
| 8617600 | Apr 13, 2027 | — | — | Yes | — | — |
| 8821930 | Apr 13, 2027 | — | — | Yes | — | — |
| 9119791 | Apr 13, 2027 | — | — | — | — | |
| 9351975 | Apr 13, 2027 | — | — | Yes | — | — |
| 9370525 | Apr 13, 2027 | — | — | Yes | — | — |
| 9855278 | Apr 13, 2027 | — | — | Yes | — | — |
| 10220042 | Apr 13, 2027 | — | — | — | — | |
| 11166960 | Apr 13, 2027 | — | — | Yes | — | — |
| 11896599 | Apr 13, 2027 | — | — | Yes | — | — |