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FERAHEME

NDA

FERUMOXYTOL | N022180 | AZURITY PHARMACEUTICALS SWITZERLAND GMBH

1 strength0 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 Luitpold Pharmaceuticals Inc. (Sheppard, Mullin, Richte... FDA-2013-P-1294 On September 30, 2013, Luitpold Pharmaceuticals Inc., through counsel at Sheppard Mullin Richter & Hampton LLP, filed a citizen petition requesting that the FDA approve any New Drug Application or supplement for injectable iron products treating iron deficiency anemia outside chronic kidney disease	505(q)	2013-11-15	Denied	Luitpold Pharmaceuticals Inc. (Sheppard

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

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia NCT04253626	Phase 3	Completed	Stanford University	83	2021-01-21 → 2024-07-01

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

API Supply Chain3 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

LEK PHARMACEUTICALS DDFERUMOXYTOL

DMF 277182013

MSN LIFE SCIENCES PRIVATE LTDFERUMOXYTOL

DMF 372652022

APICORE LLCFERUMOXYTOL

DMF 390322023

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

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
May 29, 2026	SUPPL -26	View Letter (PDF)
Jun 17, 2022	SUPPL -25	View Letter (PDF)
Sep 14, 2020	SUPPL -24	View Letter (PDF)
Oct 15, 2019	SUPPL -23	View Letter (PDF)
Feb 8, 2018	SUPPL -9	View Letter (PDF)
Dec 27, 2017	SUPPL -16	View Letter (PDF)
Mar 17, 2015	SUPPL -13	View Letter (PDF)
Mar 17, 2015	SUPPL -11	View Letter (PDF)
Jun 28, 2011	SUPPL -6	View Letter (PDF)
Nov 30, 2010	SUPPL -3	View Letter (PDF)
Nov 30, 2010	SUPPL -5	View Letter (PDF)
Jul 7, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 510MG IRON/17ML (EQ 30MG IRON/ML)

RLDAB

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jun 30, 2009

No patent or exclusivity listings for this strength.