NALMEFENE HYDROCHLORIDE | N217470 | INDIVIOR INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2025-06-20 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Nirsum Pharmaceuticals, LLC FDA-2017-P-2044 · 16 docket documents Nirsum Pharmaceuticals, LLC filed this petition under 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA Commissioner determine whether Revex (nalmefene hydrochloride injection) in strengths of 0.1 mg base/ml and 1.0 mg base/ml, subject of NDA 020-459, was withdrawn fro | 505(q) | 2017-04-04 | Denied | Nirsum Pharmaceuticals, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$46.79
per ea
Lowest NADAC/Unit
$46.79
per ea
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 12496000302OPVEE 2.7 MG NASAL SPRAY | $46.79 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.