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 | — |
Melinta Therapeutics, LLC et al v. Nexus Pharmaceuticals, Inc. 2 patentsANDA 214934minocycline | N.D. Ill. | 2021-05-14 | Terminated 2024-11-15 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Melinta Therapeutics, LLC FDA-2023-P-0127 · 8 docket documents 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 | Partially Denied | Melinta Therapeutics, LLC |
Citizen Petition from Melinta Therapeutics LLC FDA-2021-P-1123 · 12 docket documents 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 |
Citizen Petition from Pitney, Hardin, Kipp Szuch FDA-1998-P-0835 · 4 docket documents Law firm Pitney, Hardin, Kipp & Szuch filed this petition on March 31, 1998, pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting permission to file an Abbreviated Antibiotic Drug Application for Minocycline Hydrochloride Tablets in a 75 mg dosage strength, which d | Other | 2019-09-04 | Granted | Pitney, Hardin, Kipp Szuch |
Source: Regulations.gov. FDA citizen petitions matched by application number.