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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 · 4 docket documents 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	Granted	Seacross Pharma USA, Inc.

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

Clinical Trials

73 trials from ClinicalTrials.gov, 49 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of Cytoreductive Surgery and Hyperthermic Intrathoracic Pleural Chemotherapy (HITC) With Escalating Doses for Children and Adolescents With Unilateral Pleural Malignancy NCT01998529	Phase 1	Completed	M.D. Anderson Cancer Center	7	2014-08-20 → 2020-08-25
Radiation Therapy, Combination Chemotherapy, and Amifostine in Treating Patients With Head and Neck Cancer NCT00003582	Phase 1/2	Completed	University of Miami	36	1988-05 → 1996-12
Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer NCT00003927	Phase 1	Completed	City of Hope Medical Center	15	1999-05-18 → 2023-03-21
Extrapleural Pneumonectomy /Pleurectomy Decortication, IHOC Cisplatin and Gemcitabine With Amifostine and Sodium Thiosulfate Cytoprotection for Resectable Malignant Pleural Mesothelioma NCT00571298	Phase 1	Completed	Brigham and Women's Hospital	141	2007-11 → 2015-06
Subcutaneous Amifostine Safety Study NCT00158041	Phase 4	Completed	Mt. Sinai Medical Center, Miami	452	2002-01 → 2005-01
Amifostine in Treating Patients With Ovarian Epithelial Cancer Who Are Receiving Chemotherapy NCT00004166	Phase 3	Completed	Northwestern University	—	1999-10 → 2003-01
High-dose ICE With Amifostine NCT00003657	Phase 2	Completed	Dana-Farber Cancer Institute	24	1998-07 → 2002-06
Azacitidine Plus Amifostine in Treating Patients With Myelodysplastic Syndrome NCT00005598	Phase 2	Completed	University of Michigan Rogel Cancer Center	—	2000-10 → 2002-03
Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer NCT00006012	Phase 1/2	Completed	Alliance for Clinical Trials in Oncology	73	2001-02 → 2006-05
Amifostine in Treating Peripheral Neuropathy in Patients Who Have Received Chemotherapy for Cancer NCT00058071	Phase 3	Completed	Gynecologic Oncology Group	100	2003-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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)

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#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