MINOCYCLINE HYDROCHLORIDE | N050444 | REMPEX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF MELINTA THERAPEUTICS LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Melinta Subsidiary Corp. et al v. Gland Pharma Limited 4 patentsANDA 220209minocycline hydrochloride | N.D. Ill. | 2025-04-04 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Melinta Therapeutics, LLC FDA-2023-P-0127 Melinta Therapeutics, LLC and its subsidiary Rempex Pharmaceuticals, Inc. filed this citizen petition under 21 U.S.C. § 355 requesting that FDA vacate the July 22, 2022 approval of ANDA 214934 submitted by Nexus Pharmaceuticals, Inc. for a generic minocycline injection product, update its databases | 505(q) Stay Request | 2023-01-11 | Denied | Melinta Therapeutics |
Citizen Petition from Melinta Therapeutics LLC FDA-2021-P-1123 Melinta Therapeutics LLC filed this citizen petition on October 16, 2021, requesting that the FDA refuse to approve ANDA 214934 submitted by Nexus Pharmaceuticals for a generic version of MINOCIN (minocycline) for injection relying on Melinta's NDA 050444 as the reference listed drug, unless Nexus p | 505(q) | 2021-10-19 | Denied | Melinta Therapeutics LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.