DIAZEPAM | N211635 | NEURELIS INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2025-00465 | 11241414 | IPR | Padagis US LLC et al. | Trial Instituted | 2025-01-17 | 2025-09-16 |
| IPR2025-00466 | 11793786 | IPR | Padagis US LLC et al. | Trial Instituted | 2025-01-17 | 2025-09-16 |
| IPR2025-00464 | 8895546 | IPR | Padagis US LLC et al. | Trial Instituted | 2025-01-17 | 2025-09-16 |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2026-04-08 | Active | — | |
| D. Del. | 2026-03-11 | Active | — | |
| D. Del. | 2026-03-11 | Active | — | |
| D. Del. | 2025-11-26 | Active | — | |
| D. Del. | 2025-10-03 | Active | — | |
| D. Del. | 2025-07-02 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & McNamara, P.C. (on behalf of Aquestive ... FDA-2024-P-3563 · 3 docket documents Hyman, Phelps & McNamara, P.C., on behalf of Aquestive Therapeutics, Inc., submitted this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA refuse to approve any nasal spray drug product lacking food-effect studies if the active moiety has demonstr | 505(q) | 2024-07-30 | Partially Denied | Aquestive Therapeutics, Inc. |
Citizen Petition and Petition for Stay of Action from Arent Fox LLP on behalf... FDA-2019-P-5121 · 9 docket documents Arent Fox LLP, on behalf of Aquestive Therapeutics, Inc., filed a 505(q) citizen petition requesting that the FDA stay approval of Neurelis's 505(b)(2) NDA for Valtoco (diazepam intranasal solution) and require additional clinical studies, including a bridging study comparing Valtoco to Diastat (dia | 505(q) Stay Request | 2019-11-04 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$365.98
per ea
Lowest NADAC/Unit
$365.49
per ea
Brand NDCs
4
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 72252052010VALTOCO 20 MG NASAL SPRAY | $365.98 | EA | Brand | — | 2026-06-17 |
| 72252050505VALTOCO 5 MG NASAL SPRAY | $365.78 | EA | Brand | — | 2026-06-17 |
| 72252051510VALTOCO 15 MG NASAL SPRAY | $365.74 | EA | Brand | — | 2026-06-17 |
| 72252051005VALTOCO 10 MG NASAL SPRAY | $365.49 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Code | Date | Status |
|---|---|---|
| NPP | Apr 15, 2028 | Active |
| ODE-279 | Jan 10, 2027 | < 1 year |