EPINEPHRINE | N019430 | VIATRIS SPECIALTY LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2010-07-14 | Terminated 2011-05-10 | — |
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. |
Citizen Petition from Belcher Pharmaceuticals, LLC FDA-2017-P-3352 · 5 docket documents Belcher Pharmaceuticals, LLC filed this petition on May 25, 2017, requesting that the FDA amend the sulfite warning requirement in 21 C.F.R. 201.22(c) for sulfite-containing epinephrine for injection used in emergency situations to acknowledge the availability of sulfite-free epinephrine products an | Other | 2017-05-26 | Open | Belcher Pharmaceuticals, LLC |
Citizen Petition From Mylan Specialty, L.P. FDA-2015-P-0181 · 9 docket documents Mylan Specialty, L.P. filed this citizen petition on January 16, 2015, under 21 USC 355 and 21 CFR 10.30, requesting that the FDA refrain from approving Teva Pharmaceuticals' ANDA 90-589 for an epinephrine auto-injector referencing EpiPen® as the reference listed drug, unless the agency determines t | 505(q) | 2015-01-20 | Denied | Mylan Specialty, L.P. |
Dey Pharma, L.P. - Citizen Petition FDA-2009-P-0578 · 6 docket documents Dey Pharma, L.P., the distributor of EpiPen (epinephrine) Auto-Injector, filed this citizen petition under Section 505(q) of the Federal Food, Drug and Cosmetic Act requesting that the FDA decline to approve or assign an "AB" rating to any proposed generic ANDA for EpiPen auto-injectors unless they | 505(q) | 2009-12-07 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$142.84
per ea
Lowest NADAC/Unit
$141.53
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 49502010102EPINEPHRINE 0.15 MG AUTO-INJCT | $142.84 | EA | Generic | — | 2026-06-17 |
| 49502010202EPINEPHRINE 0.3 MG AUTO-INJECT | $141.53 | 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.