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	219868-001	Oct 16, 2025		RX	Yes	Yes
Sandoz	FERUMOXYTOL	ferumoxytol	SOLUTION;INTRAVENOUS	206604-001	Jan 15, 2021	AB	RX	No	No
Covis	FERABRIGHT	ferumoxytol	SOLUTION;INTRAVENOUS	219868-002	Oct 16, 2025		RX	Yes	Yes

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	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	7,553,479

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: February 5, 2026

Ferumoxytol (marketed as Feraheme) is an iron oxide nanoparticle approved for the treatment of iron deficiency anemia in adult patients with Chronic Kidney Disease (CKD). It faces a competitive landscape dominated by traditional iron therapies but benefits from its unique formulation and indications.

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Market Size and Growth Potential

The global iron deficiency anemia (IDA) treatment market, estimated at approximately USD 3.2 billion in 2022, is projected to reach USD 4.1 billion by 2027, registering a CAGR of about 5.2% [1]. Ferumoxytol accounts for roughly 20-25% of this market segment, with its revenue primarily derived from North America, where it holds around 40-50% market share in IV iron therapies for CKD patients.

The compound's higher cost, roughly USD 700-900 per dose, limits broad adoption but is offset by its rapid onset and suitability for patients intolerant of oral iron or with gastrointestinal absorption issues.

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Market Drivers

1. CKD Prevalence and Treatment Needs
   CKD affects approximately 10% of the global population, with an increasing number progressing to End Stage Renal Disease (ESRD), requiring dialysis and anemia management [2]. Anemic CKD patients often benefit from IV iron therapies, including ferumoxytol.

2. Advantage over Traditional Iron Formulations
   Ferumoxytol's rapid infusion (up to 30 seconds per dose) and lower risk of hypersensitivity reactions make it preferable over older formulations like iron sucrose or ferric gluconate.

3. Reimbursement and Healthcare Integration
   Insurance coverage in North America supports utilization. The drug is often used off-label in other anemia populations, expanding its potential market.

4. Clinical Trials and New Indications
   Ongoing studies evaluate ferumoxytol in different anemia contexts, including oncology-related anemia, broadening its therapeutic scope.

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Competitive Landscape and Market Share

Company	Product	Estimated Market Share	Key Differentiator
AMAG Pharmaceuticals	Feraheme	50%	First-to-market, established brand
Vifor Pharma	Ferinject	30%	Approved in Europe, versatile IV iron
Others	Various (iron sucrose, iron dextran)	20%	Lower cost, generic options

Ferumoxytol maintains a competitive edge in efficacy and safety profiles; however, price sensitivity affects penetration in certain regions.

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Regulatory and Policy Factors

• FDA Approval: 2009 for iron deficiency anemia in adults with CKD.
• European Market: Approved as Ferinject, with different dosing protocols.
• Off-label Use: Limited but emerging, especially for iron deficiency anemia outside CKD.

Policy shifts toward cost-effective anemia management influence adoption rates. The cost-effectiveness profile favors ferumoxytol under specific clinical circumstances, particularly for patients with poor oral iron response.

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Revenue Projections and Financial Trajectory

Based on current market trends, ferumoxytol’s revenue grew modestly from approximately USD 500 million in 2020 to USD 700 million in 2022. Growth is projected at a CAGR of 6-8% through 2027, driven by:

• Increasing CKD prevalence and dialysis patient population.
• Expanding clinical research supporting broader indications.
• Entry into emerging markets, notably Asia, where CKD management is rising.

Potential revenue catalysts include the FDA's approval of new indications or formulations, reductions in manufacturing costs, or strategic acquisitions.

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Challenges and Risks

• Pricing Pressures: Increasing competition from low-cost generics and biosimilar iron products can erode margins.
• Regulatory Changes: Cost-containment policies could restrict reimbursement.
• Off-label Use: Limited regulatory approval outside CKD constrains commercialization efforts.

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Key Takeaways

• Ferumoxytol is a key player in the IV iron therapy segment for anemia associated with CKD.
• The market is expected to grow at over 6% annually through 2027, driven by rising CKD prevalence.
• It faces competition mainly from older iron formulations and biosimilars but maintains a niche through safety and rapid infusion advantages.
• Revenue remains stable but is sensitive to pricing policies and regulatory shifts.
• Expansion into new indications and markets represents the primary growth opportunities.

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FAQs

1. How does ferumoxytol compare cost-wise to other iron therapies?
It costs approximately USD 700-900 per dose, higher than traditional formulations like iron sucrose (~USD 100-200 per dose), but offers clinical advantages that justify the premium in specific patient populations.

2. What are the primary clinical benefits of ferumoxytol?
It offers rapid infusion times, a lower risk of hypersensitivity, and effective iron replenishment in CKD patients, often with fewer side effects.

3. What are the major barriers to market growth?
Pricing pressures, competition from generics, and regulatory restrictions on off-label use limit broader adoption beyond CKD.

4. Which regions present the highest growth opportunities?
North America remains the dominant market; expanding into Europe, Japan, and emerging Asian economies offers significant upside due to increasing CKD burdens.

5. Are there any upcoming regulatory reviews or approvals expected for ferumoxytol?
As of 2023, no major submissions are pending. Clinical trials exploring new indications could lead to future regulatory filings.

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References

[1] MarketDataForecast, "Iron Deficiency Anemia Treatment Market," 2022.
[2] Global Burden of Disease Study, "CKD Epidemiology," 2022.