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ETHYOL

NDA

AMIFOSTINE | N020221 | LEGACY PHARMA INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Seacross Pharma USA, Inc. FDA-2024-P-5232 Seacross Pharma USA, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that FDA determine whether ETHYOL (amifostine) for Injection, 500mg/vial, NDA 020221, held by Cosette Pharmaceuticals Inc., was discontinued for reasons of safety or effe	505(q)	2024-11-08	Withdrawn	Seacross Pharma USA

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs4 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SUN PHARMACEUTICAL INDUSTRIES LTDAMIFOSTINE USP

DMF 171862004

LIANYUNGANG RUNZHONG PHARMACEUTICAL CO LTDAMIFOSTINE

DMF 217652008

SIPSY SNCInactiveAMIFOSTINE

DMF 91031991

AXITEC CO LTDInactiveAMIFOSTINE USP (NON-STERILE BULK DRUG)

DMF 188982005

CHANGZHOU AHK TECH INCInactiveAMIFOSTINE

DMF 228732009

W R GRACE AND CO -CONNInactiveAMIFOSTINE

DMF 229092009

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Jul 26, 2019	SUPPL -36	View Letter (PDF)
May 30, 2017	SUPPL -33	View Letter (PDF)
Dec 19, 2016	SUPPL -32	View Letter (PDF)
Nov 13, 2008	SUPPL -24	View Letter (PDF)
Apr 5, 2006	SUPPL -20	View Letter (PDF)
Apr 15, 2003	SUPPL -17	View Letter (PDF)
Feb 20, 2002	SUPPL -15	View Letter (PDF)
Jun 24, 1999	SUPPL -12	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 8, 1995

No patent or exclusivity listings for this strength.

#002 — 375MG/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 10, 1999