MELPHALAN HYDROCHLORIDE | N207155 | ACROTECH BIOPHARMA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ACROTECH BIOPHARMA INC. et al v. GLAND PHARMA LIMITED 3 patentsANDA 220632Melphalan Hydrochloride | D.N.J. | 2025-11-26 | Active | — |
ACROTECH BIOPHARMA LLC v. ALEMBIC PHARMACEUTICALS, LTD 4 patentsANDA 212810Melphalan HCl (Captisol®-enabled Melphalan HCl) | D.N.J. | 2020-12-15 | Terminated 2020-12-15 | — |
| D. Del. | 2019-10-29 | Terminated 2021-05-03 | — | |
CyDex Pharmaceuticals, Inc. v. Alembic Global Holding SA et al 2 patentsANDA 212810Melphalan hydrochloride | D. Del. | 2019-05-23 | Terminated 2021-06-10 | — |
CyDex Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc. et al 3 patentsANDA 209323Melphalan HCl | D. Del. | 2017-12-20 | Terminated 2019-11-06 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Axinn, Veltrop & Harkrider LLP FDA-2016-P-3598 · 5 docket documents On October 27, 2016, Chad A. Landmon, filing on behalf of a client through the law firm Axinn, Veltrop & Harkrider LLP, submitted a citizen petition requesting that the FDA designate Evomela (melphalan hydrochloride) for Injection, 50 mg base per vial, approved under NDA 207155 by Spectrum Pharmaceu | 505(q) | 2016-10-28 | Granted | Axinn, Veltrop & Harkrider LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.