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FERABRIGHT

NDA

FERUMOXYTOL | N219868 | AZURITY PHARMACEUTICALS SWITZERLAND GMBH

2 strengths0 unique patents1 unique exclusivity

Patent Timeline

0 unique patents, 1 exclusivity by expiration date

TodayExclusivity

2027

2028

Today

Oct. 16, 2028

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

3 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-6222 · 11 docket documents Law firm Hyman, Phelps & McNamara, P.C. filed this citizen petition requesting that the FDA require submission of a Prior Approval Supplement with bioequivalence testing when sponsors of carbohydrate-iron complex products such as ferric carboxymaltose, ferric derisomaltose, ferumoxytol, iron dextran	Other	2025-11-17	Open	Hyman, Phelps & McNamara, P.C.
AMAG Pharmaceuticals, Inc. - Citizen Petition FDA-2013-P-0885 · 3 docket documents AMAG Pharmaceuticals, Inc., sponsor of Feraheme (ferumoxytol) injection approved under NDA 22-180, filed this citizen petition under 21 USC 355 and 21 CFR 10.30 requesting that FDA refrain from approving any ANDA for a generic version of Feraheme until post-market contract studies on the generic sod	505(q)	2013-08-09	Open	—
Luitpold Pharmaceuticals, Inc. - Citizen Petition FDA-2008-P-0524 · 5 docket documents Luitpold Pharmaceuticals, Inc. filed this citizen petition on September 23, 2008, requesting that the FDA require any new drug application (NDA) for ferumoxytol for iron deficiency anemia to contain the same rigorous clinical trial data and safety labeling as other intravenous iron dextran products,	505(q)	2008-10-02	Denied	—

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

Clinical Trials

75 trials from ClinicalTrials.gov — 7 recruiting, 47 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)NCT03619850	Phase 3	Recruiting	AMAG Pharmaceuticals, Inc.	129	2018-08-13 → 2026-08-31
Gadolinium and Ferumoxytol MRI in Diagnosing Patients With Abnormalities in the Central Nervous System NCT03270059	Phase 2	Recruiting	OHSU Knight Cancer Institute	150	2017-10-06 → 2028-12-15
A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects NCT03893045	Phase 3	Recruiting	AMAG Pharmaceuticals, Inc.	75	2019-09-18 → 2026-10
Virtual Histology of the Bladder Wall for Bladder Cancer Staging NCT04369560	Early Phase 1	Recruiting	Jodi Maranchie	42	2025-05-23 → 2028-12-30
Early Antenatal Support for Iron Deficiency Anemia NCT04278651	Phase 4	Recruiting	Thomas Jefferson University	80	2021-09-29 → 2026-12-30
Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer NCT01542879	Phase 1/2	Recruiting	Heike E Daldrup-Link	75	2012-02 → 2026-12
Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient NCT04268849	Phase 3	Recruiting	Auerbach Hematology Oncology Associates P C	104	2020-02-27 → 2026-02
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
Ferumoxytol for Magnetic Resonance Imaging of Myocardial Infarction NCT01323296	N/A	Completed	University of Edinburgh	15	2010-11 → 2012-10
Iron Indices and Intravenous Ferumoxytol: Time to Steady State NCT01148745	Phase 4	Completed	Dialysis Clinic, Inc.	15	2010-03 → 2010-05

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

1 letter from Drugs@FDA

Date	Submission	Document
Oct 20, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 300MG IRON/10ML (EQ 30MG IRON/ML)

RLD

0 patents1 exclusivity▴

SOLUTION;INTRAVENOUS | Approved: Oct 16, 2025

Exclusivities (1)

Code	Date	Status
NP	Oct 16, 2028	Active

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

RLD

0 patents1 exclusivity▾

SOLUTION;INTRAVENOUS | Approved: Oct 16, 2025