ENALAPRIL MALEATE | N208686 | AZURITY PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2023-09-01 | Terminated 2023-11-01 | — | |
AZURITY PHARMACEUTICALS, INC. v. NOVITIUM PHARMA, LLC 2 patentsANDA 212408enalapril maleate | D. Del. | 2023-02-14 | Terminated 2024-04-08 | — |
AZURITY PHARMACEUTICALS, INC. v. NOVITIUM PHARMA, LLC 2 patentsANDA 212408enalapril maleate | D.N.J. | 2022-10-03 | Terminated 2023-01-23 | — |
| D. Del. | 2021-12-02 | Terminated 2023-10-12 | — | |
| D. Del. | 2021-10-15 | Terminated 2025-01-02 | — | |
| D.N.J. | 2021-06-22 | Terminated 2021-09-10 | — | |
| D. Del. | 2021-02-11 | Terminated 2023-06-22 | — | |
| D. Del. | 2020-09-18 | Terminated 2021-05-21 | — | |
| D. Del. | 2020-09-18 | Terminated 2021-06-29 | — | |
| D. Del. | 2020-06-04 | Terminated 2021-10-20 | — | |
| D. Del. | 2019-11-05 | Terminated 2023-02-10 | — | |
| D. Del. | 2019-04-11 | Terminated 2021-06-29 | — | |
Silvergate Pharmaceuticals, Inc. v. Bionpharma Inc. 3 patentsANDA 212408enalapril maleate | D. Del. | 2018-12-12 | Terminated 2021-05-17 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Wilson Sonsini Goodrich & Rosati (Silvergate Pharmaceut... FDA-2017-P-2092 · 18 docket documents Wilson Sonsini Goodrich & Rosati filed this citizen petition on behalf of Silvergate Pharmaceuticals, Inc., requesting that the FDA require all ANDA applicants referencing Silvergate's NDA No. 208686 for Epaned (enalapril maleate) Oral Solution 1 mg/mL to conduct in vivo bioequivalence studies with | 505(q) | 2017-04-04 | Denied | Wilson Sonsini Goodrich & Rosati (Silvergate Pharmaceuticals, Inc.) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$4.48
per ml
Lowest NADAC/Unit
$0.9921
per ml
Brand NDCs
1
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 52652400101EPANED 1 MG/ML ORAL SOLUTION | $4.48 | ML | Brand | $0.9921 | 2026-06-17 |
| 69238214107ENALAPRIL 1 MG/ML ORAL SOLN | $0.9921 | ML | Generic | — | 2026-06-17 |
| 52536040101ENALAPRIL 1 MG/ML ORAL SOLN | $0.9921 | ML | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.