ENALAPRIL MALEATE | N208686 | AZURITY PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
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. | 2021-10-15 | Terminated 2025-01-02 | — | |
| D. Del. | 2019-11-05 | Terminated 2023-02-10 | — | |
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 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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.