EPINEPHRINE | N214697 | ARS PHARMACEUTICALS OPERATIONS INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2021-01324 | 10682414 | IPR | Amphastar Pharmaceuticals, Inc. | Final Written Decision | 2021-08-12 | 2025-03-07 |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ARS PHARMACEUTICALS OPERATIONS, INC. et al v. LUPIN INC. et al 8 patentsANDA 221269epinephrine | D.N.J. | 2026-02-26 | Terminated 2026-04-27 | — |
ARS PHARMACEUTICALS OPERATIONS, INC. et al v. LUPIN INC. et al 8 patentsANDA 220047epinephrine nasal spray | D.N.J. | 2025-08-29 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Viatris Inc. FDA-2023-P-2392 · 37 docket documents Viatris Inc. filed this citizen petition under Section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require additional pharmacokinetic and pharmacodynamic studies before approving NDA 214697 for neffy (intranasal epinephrine) for emergency treatment of allergic reactions a | 505(q) | 2023-06-12 | Denied | Viatris Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$360.29
per ea
Lowest NADAC/Unit
$359.83
per ea
Brand NDCs
2
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 82580001002NEFFY 1 MG/0.1 ML NASAL SPRAY | $360.29 | EA | Brand | — | 2026-06-17 |
| 82580002002NEFFY 2 MG/0.1 ML NASAL SPRAY | $359.83 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.