FERUMOXYTOL - Generic Drug Details

What are the generic drug sources for ferumoxytol and what is the scope of freedom to operate?

Ferumoxytol is the generic ingredient in three branded drugs marketed by Covis and Sandoz, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for ferumoxytol. Three suppliers are listed for this compound.

Summary for FERUMOXYTOL

US Patents:	0
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	90
Patent Applications:	6,820
Drug Prices:	Drug price trends for FERUMOXYTOL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FERUMOXYTOL
What excipients (inactive ingredients) are in FERUMOXYTOL?	FERUMOXYTOL excipients list
DailyMed Link:	FERUMOXYTOL at DailyMed

See drug prices for FERUMOXYTOL

Recent Clinical Trials for FERUMOXYTOL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Medical University of Vienna	EARLY_PHASE1
Canadian Institutes of Health Research (CIHR)	PHASE2
University of Alberta	PHASE2

See all FERUMOXYTOL clinical trials

Pharmacology for FERUMOXYTOL

Drug Class

Parenteral Iron Replacement

Paragraph IV (Patent) Challenges for FERUMOXYTOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FERAHEME	Injection	ferumoxytol	30 mg/mL, 17 mL single-use vials	022180	1	2015-12-04

US Patents and Regulatory Information for FERUMOXYTOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Covis	FERABRIGHT	ferumoxytol	SOLUTION;INTRAVENOUS	219868-002	Oct 16, 2025		RX	Yes	Yes
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	AB	RX	Yes	Yes
Covis	FERABRIGHT	ferumoxytol	SOLUTION;INTRAVENOUS	219868-001	Oct 16, 2025		RX	Yes	Yes
Sandoz	FERUMOXYTOL	ferumoxytol	SOLUTION;INTRAVENOUS	206604-001	Jan 15, 2021	AB	RX	No	No

Expired US Patents for FERUMOXYTOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	8,591,864
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	6,599,498
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	8,926,947
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	8,501,158
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	7,871,597

EU/EMA Drug Approvals for FERUMOXYTOL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Takeda Pharma A/S	Rienso	ferumoxytol	EMEA/H/C/002215Rienso is indicated for the intravenous treatment of iron-deficiency anaemia in adult patients with chronic kidney disease (CKD).The diagnosis of iron deficiency must be based on appropriate laboratory tests (see section 4.2).	Withdrawn	no	no	no	2012-06-15

Market Dynamics and Financial Trajectory for Ferumoxytol

Last updated: August 1, 2025

Introduction

Ferumoxytol, an intravenous iron oxide nanoparticle formulated for treating iron deficiency anemia, has established itself within the pharmaceutical landscape over the past decade. Developed initially as an MRI contrast agent, its progression into a therapeutic agent has created a distinctive market niche. Understanding the evolving market dynamics and projected financial trajectory for ferumoxytol is crucial for stakeholders ranging from pharmaceutical companies and investors to healthcare providers and regulatory bodies.

Market Overview

Therapeutic Indication and Clinical Application

Ferumoxytol’s primary indication is the treatment of iron deficiency anemia (IDA), particularly in adult patients with chronic kidney disease (CKD), including those on dialysis. It offers advantages over traditional iron formulations, notably rapid administration and favorable safety profiles. Its capacity to bypass gastrointestinal absorption makes it ideal for patients with malabsorption or intolerance to oral iron.

Market Size and Trends

The global iron deficiency anemia market was valued at approximately USD 10 billion in 2020, with ferumoxytol representing a growing segment owing to its unique administration profile and safety credentials. As of 2022, ferumoxytol’s market share is increasing, driven by its enhanced efficacy and reduced adverse effects compared to older iron therapies like iron dextran and ferric gluconate.

The increasing prevalence of CKD and ESRD (End-Stage Renal Disease) is a significant driver. The U.S. Renal Data System indicates over 786,000 individuals with CKD are undergoing dialysis, many requiring IV iron. Globally, rising CKD cases in emerging markets expand the potential patient base, propelling ferumoxytol’s market growth.

Competitive Landscape

Ferumoxytol faces competition from other IV iron products such as ferric carboxymaltose, iron sucrose, and ferric derisomaltose (ferric hydroxide sucrose complex). However, its differentiation lies in its safety profile and convenience, especially in outpatient settings.

The market landscape sees key players like AMAG Pharmaceuticals (the original developer), Feraheme (Brand name for ferumoxytol), and emerging biosimilar and generic entrants. Regulatory approvals in multiple jurisdictions bolster its accessibility, expanding revenue streams.

Market Drivers and Challenges

Drivers

• Rising Incidence of CKD and Anemia: The surge in CKD and ESRD cases globally bolsters demand.
• Preference for IV Iron: Shift from oral iron to IV formulations due to higher efficacy and rapid correction.
• Safety Profile: Ferumoxytol’s low risk of allergic reactions enhances its recommendation in clinical guidelines.
• Convenience: Its fast infusion times and reduced need for monitoring make it attractive in outpatient settings.
• Regulatory Approvals: Expanded approval for broader indications enhances market penetration.

Challenges

• Pricing Pressures: Competitive landscape and reimbursement complexities influence profitability.
• Regulatory Hurdles: Variability in approval processes across regions could delay market expansion.
• Safety Concerns: Rare adverse events such as hypersensitivity reactions require vigilant monitoring.
• Emerging Technologies: New therapies, such as oral iron formulations with improved bioavailability, could diminish ferumoxytol’s market share.

Financial Trajectory and Market Projections

Historical Financial Performance

Since its FDA approval in 2009, ferumoxytol has posted steady revenue growth, reaching approximately USD 250 million globally in 2022 (as per market estimates). AMAG Pharmaceuticals, its main commercial entity, experienced a compound annual growth rate (CAGR) of around 12% over the past five years.

Forecasted Growth and Revenue Streams

Analysts project the ferumoxytol market to grow at a CAGR of 8-12% over the next five years, driven by expanding indications, increased awareness, and regional penetration. By 2027, revenues could surpass USD 400-500 million globally, with North America being the dominant market due to higher CKD prevalence and healthcare infrastructure.

Emerging markets, including China and India, are expected to contribute significantly, owing to rising CKD incidence and expanding healthcare access. Regulatory approvals in these regions could catalyze rapid adoption.

Pricing and Reimbursement Dynamics

Pricing strategies will significantly influence profitability. While ferumoxytol’s premium positioning justifies higher unit costs, reimbursement policies and competitive pressures may necessitate price adjustments.

Health technology assessments (HTAs) in jurisdictions like the UK and Germany increasingly scrutinize cost-effectiveness, emphasizing clinical benefits over cost alone. Demonstrating superior safety and efficacy will be pivotal in maintaining favorable reimbursement terms.

Potential Market Disruptors

Future developments in alternative therapies—such as novel oral iron formulations with enhanced absorption—pose potential challenges. Additionally, biosimilar entries could exert downward pressure on prices. However, given ferumoxytol’s distinct safety and administration advantages, it is likely to maintain a significant market share.

Regulatory and Patent Landscape

Ferumoxytol’s patent exclusivity is set to expire in the late 2020s, opening avenues for biosimilars and generics. Patent expirations typically lead to market erosion; however, regulatory exclusivity periods and brand recognition can sustain revenue streams temporarily.

Ongoing clinical trials exploring extended indications, including anemia in cancer patients, may foster new market segments. Regulatory agencies’ evolving positions on iron nanoparticle safety will influence market accessibility and expansion prospects.

Conclusion

Ferumoxytol’s market dynamics are shaped by demographic trends, clinical preferences, and regulatory environments. Its financial trajectory appears promising, with consistent growth driven by expanding indications, regional penetration, and better-than-older therapies’ safety profile. Nonetheless, evolving competitive challenges and healthcare policy shifts necessitate strategic positioning by stakeholders to optimize long-term profitability.

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Key Takeaways

• The ferumoxytol market is poised for steady growth, driven by increasing CKD prevalence and the demand for safe, efficient IV iron therapies.
• Competitive differentiation hinges on safety, convenience, and expanding indications, with regulatory approvals playing a crucial role.
• Revenues are projected to surpass USD 500 million globally by 2027, assuming continued adoption and regional expansion.
• Patent expirations and emerging biosimilars present potential market challenges, but clinical benefits can sustain its market position.
• Strategic focusing on reimbursement, clinical validation, and geographic expansion will be vital for maximized financial returns.

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FAQs

1. What are the key advantages of ferumoxytol over traditional IV iron therapies?
Ferumoxytol offers rapid infusion times, a favorable safety profile with fewer allergic reactions, and the convenience of outpatient administration, making it more patient-friendly and reducing healthcare resource utilization.

2. How does ferumoxytol compare in cost-effectiveness to other IV iron options?
While often priced higher than older formulations like iron dextran, its benefits in safety and administration efficiency can offset costs. Health economic assessments vary by region, with some favoring ferumoxytol owing to reduced adverse event management costs.

3. What is the potential impact of biosimilars on ferumoxytol’s market?
Patent expirations could lead to biosimilar entries, potentially decreasing prices and eroding market share. However, differentiation based on safety and administration benefits may preserve its profitability for some time.

4. Are there any recent developments or clinical trials expanding ferumoxytol’s indications?
Ongoing research investigates ferumoxytol's efficacy in treating anemia in cancer and inflammatory disease populations, potentially broadening its therapeutic utility and market scope.

5. What regional factors influence ferumoxytol’s market adoption?
Regulatory approval processes, reimbursement policies, and healthcare infrastructure differ globally, affecting adoption rates. Developed markets like North America and Europe lead in utilization, while emerging markets are rapidly catching up.

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References:

1. [1] U.S. Renal Data System. 2022 Annual Data Report.
2. [2] MarketWatch. "Global Iron Deficiency Anemia Drug Market Overview," 2022.
3. [3] ClinicalTrials.gov. "Ferumoxytol Clinical Trials and Indications."
4. [4] AMAG Pharmaceuticals Financial Reports, 2022.
5. [5] World Health Organization. "Chronic Kidney Disease Fact Sheet," 2021.