RUFINAMIDE | A204964 | LUPIN LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2013-07-24 | Terminated 2016-10-13 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Lupin Pharmaceuticals, Inc. - Citizen Petition FDA-2013-P-0573 · 4 docket documents Lupin Pharmaceuticals, Inc. filed this citizen petition on May 9, 2013, requesting that the FDA determine whether Eisai Inc.'s BANZEL (rufinamide) Tablets, 100 mg (NDA 21911) was voluntarily withdrawn from marketing for safety or effectiveness reasons, and if not, to find the product eligible for AN | 505(q) | 2013-05-23 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.39
per ea
Lowest NADAC/Unit
$0.8636
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 68180080416RUFINAMIDE 400 MG TABLET | $1.39 | EA | Generic | — | 2026-06-17 |
| 68180080316RUFINAMIDE 200 MG TABLET | $0.8636 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.