FERAHEME Drug Patent Profile

When do Feraheme patents expire, and what generic alternatives are available?

Feraheme is a drug marketed by Covis and is included in one NDA.

The generic ingredient in FERAHEME is ferumoxytol. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the ferumoxytol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Feraheme

A generic version of FERAHEME was approved as ferumoxytol by SANDOZ on January 15^th, 2021.

Summary for FERAHEME

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	61
Drug Prices:	Drug price information for FERAHEME
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FERAHEME
What excipients (inactive ingredients) are in FERAHEME?	FERAHEME excipients list
DailyMed Link:	FERAHEME at DailyMed

See drug prices for FERAHEME

Recent Clinical Trials for FERAHEME

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

Sponsor	Phase
University of Alberta	PHASE2
Canadian Institutes of Health Research (CIHR)	PHASE2
Lipella Pharmaceuticals, Inc.	Early Phase 1

See all FERAHEME clinical trials

Pharmacology for FERAHEME

Drug Class

Parenteral Iron Replacement

Paragraph IV (Patent) Challenges for FERAHEME

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 FERAHEME

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	AB	RX	Yes	Yes

Expired US Patents for FERAHEME

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009

EU/EMA Drug Approvals for FERAHEME

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

International Patents for FERAHEME

See the table below for patents covering FERAHEME around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2334555
European Patent Office	1522318
Japan	2002541218
European Patent Office	1169062	OXYDES DE FER COLLOIDAUX THERMOSTABLES RECOUVERTS DE CARBOHYDRATES REDUITS ET DES DERIVES DE CARBOHYDRATES (HEAT STABLE COATED COLLOIDAL IRON OXIDES)
Cyprus	1109527

Supplementary Protection Certificates for FERAHEME

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169062	2012C/052	Belgium		PRODUCT NAME: FERUMOXYTOL; AUTHORISATION NUMBER AND DATE: EU/1/12/774/001 20120620
1169062	300558	Netherlands		PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615
1169062	1290043-7	Sweden		PRODUCT NAME: FERUMOXYTOL; REG. NO/DATE: EU/1/12/774/001 20120615
1169062	CA 2012 00050	Denmark
1169062	92114	Luxembourg		PRODUCT NAME: FERUMOXYTOL

Market Dynamics and Financial Trajectory for Feraheme: A Comprehensive Analysis

Last updated: July 27, 2025

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Introduction

Feraheme (ferumoxytol) is an intravenous iron replacement therapy primarily indicated for the treatment of iron deficiency anemia (IDA), particularly in chronic kidney disease (CKD) patients. Approved by the U.S. Food and Drug Administration (FDA) in 2009, Feraheme has established a notable presence in the hematology and nephrology markets. As the pharmaceutical landscape evolves, understanding the intricate market dynamics and financial trajectory of Feraheme becomes vital for stakeholders—ranging from investors to healthcare providers.

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Market Overview and Therapeutic Positioning

Feraheme operates within the broader intravenous (IV) iron therapy segment, which is increasingly favored over oral formulations due to higher efficacy and better tolerability in certain patient populations, especially those with CKD, cancer-related anemia, or intolerance to oral iron. The global preference for IV iron therapies stems from their rapid action, high bioavailability, and suitable profiles for outpatient and inpatient settings.

The global anemia market is projected to grow substantially, driven chiefly by increasing prevalence of CKD, aging populations, and rising awareness of anemia management. The Kidney Disease: Improving Global Outcomes (KDIGO) guidelines and other treatment protocols underscore IV iron as a frontline therapy in CKD-related anemia, further cementing Feraheme's clinical value.

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Market Dynamics Shaping Feraheme

1. Demographic and Epidemiological Trends
The prevalence of CKD affects approximately 10% of the global population, with higher concentrations in North America, Europe, and Asia. The expanding CKD population directly correlates with increased demand for IV iron therapies like Feraheme. Aging populations exacerbate this trend, given their higher susceptibility to anemia and renal impairment.

2. Competitive Landscape and Market Share
Feraheme competes against other IV iron formulations, including Ferrlecit (sodium ferric gluconate), Venofer (iron sucrose), Injectafer (ferric carboxymaltose), and newer agents like Monofer. Among these, Injectafer has gained significant market share owing to its higher single-dose capability and favorable safety profile. However, Feraheme’s unique benefits—such as rapid infusion times and proven efficacy—continue to sustain its market position, especially in specific clinical settings.

3. Regulatory and Reimbursement Environment
Reimbursement policies across different regions are critical in dictating Feraheme’s uptake. In the U.S., coverage by Medicare and private insurers facilitates access, but reimbursement constraints and formulary positioning can influence prescribing patterns. Regulatory approvals extend Feraheme's market reach into Canada, Europe, and Asia, with regional regulatory nuances affecting commercial strategies.

4. Clinical Efficacy and Safety Profile
Feraheme’s safety profile—low incidence of hypersensitivity reactions and ability to administer high doses in a single infusion—positions it favorably among IV iron therapies. Continuous pharmacovigilance and post-market studies bolster confidence among clinicians, impacting demand dynamics positively.

5. Manufacturing and Supply Chain Factors
As a specialty pharmaceutical, manufacturing capacity and supply chain stability are pivotal. Any disruptions or scaling limitations can influence availability and financial performance. The manufacturer’s ability to innovate and optimize production costs directly affects profit margins.

6. Technological and Formulation Innovations
Efforts to develop next-generation formulations with improved safety, dosing, and ease of administration influence competitive dynamics. The emergence of biosimilars or generic equivalents could exert downward pressure on prices and profit margins.

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Financial Trajectory and Revenue Projections

1. Historical Financial Trends
Since its FDA approval, Feraheme's revenue growth has experienced fluctuations driven by market competition, pricing strategies, and clinical adoption rates. For instance, in the fiscal year 2021, the product generated approximately $200 million in global sales, representing a modest growth compared to previous years, influenced by increased competition.

2. Market Penetration and Sales Drivers
The core sales driver remains the large CKD and oncology markets. Growth is also fostered by expanding indications, including explorations in other anemia-related conditions, and improved global access in emerging markets. Enhanced awareness and guideline endorsements (e.g., KDIGO recommendations) fuel further adoption.

3. Strategic Pricing and Contracting
Pricing strategies involve negotiations with healthcare providers and insurers. Premium pricing remains justified by clinical benefits, but price competition could dampen margins. Value-based contracts and outcome-based reimbursement models are emerging trends influencing future revenue streams.

4. R&D Investment and Pipeline Development
Investment in research and development for new formulations or indications can divert financial resources but also offers growth opportunities. Expanding into novel therapeutic areas or developing combination therapies could diversify revenue sources.

5. Impact of Market Competition and Patent Landscape
Patent expirations of key formulations and the entry of biosimilars threaten Feraheme’s market exclusivity. While Feraheme’s original patents might have been challenged, the company’s strategic innovations and formulations can sustain market relevance. Nonetheless, competitive pressures are expected to temper growth trajectories over the next decade.

6. Forecasting Outlook
Analysts project a compound annual growth rate (CAGR) of approximately 4-6% over the next five years, contingent on global expansion, regulatory approvals, market acceptance, and competitive dynamics. Market analysts such as EvaluatePharma and IQVIA estimate that the global IV iron therapy market could reach $5-6 billion by 2027, with Feraheme capturing an increasing share.

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Global Regional Outlook

North America:
The largest market, driven by high CKD prevalence, advanced healthcare infrastructure, and robust reimbursement. Growth is expected to be steady, with innovations enhancing clinical usage.

Europe:
A mature but expanding market, with national guidelines supporting IV iron use. Reimbursement variability influences sales dynamics.

Asia-Pacific:
High-growth potential due to increasing CKD incidence, expanding healthcare systems, and rising awareness. Regulatory pathways are becoming more streamlined for innovative drugs like Feraheme, opening avenues for accelerated growth.

Emerging Markets:
Potential for rapid growth due to unmet needs and increasing adoption of IV iron therapies. Challenges include pricing, supply chain issues, and regulatory hurdles.

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Regulatory and Commercial Strategies

Feraheme’s future financial trajectory hinges on proactive regulatory strategies, including seeking approvals for new indications and formulations. Expanding into adjunct markets such as pediatric anemia or iron deficiency in chronic inflammatory diseases could diversify revenue streams.

Broadening clinical data and real-world evidence presentations enhance FDA and global regulatory body confidence, bolstering market access and reimbursement negotiations.

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Key Challenges and Risks

• Intense Competition: Entry of biosimilars and superior formulations could erode market share.
• Pricing Pressures: Cost containment initiatives and value-based pricing may limit revenue growth.
• Regulatory Risks: Delays or denials of approvals for new indications could impede expansion.
• Manufacturing Constraints: Quality control issues or supply disruptions could adversely affect sales.
• Market Saturation: In mature markets, growth may plateau without innovation.

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Key Takeaways

• The global market for IV iron therapies, including Feraheme, is poised for steady growth driven by demographic trends and clinical guidelines favoring IV over oral formulations.
• Feraheme’s competitive advantages—rapid infusion, safety profile, and efficacy—maintain its relevance, but intense market competition necessitates innovation.
• Financial performance relies on strategic pricing, market access, and expansion into emerging markets, with forecasted growth at 4-6% CAGR over the coming years.
• Regulatory developments and patent landscapes are pivotal; proactive strategies are essential to sustaining revenue.
• Ongoing clinical research and pipeline diversification are critical for long-term financial stability amid market pressures.

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FAQs

1. What are the primary factors influencing Feraheme's market share?
Clinical efficacy, safety profile, infusion advantages, competitive landscape, and reimbursement policies primarily determine market share.

2. How does Feraheme compare economically to oral iron therapies?
While more expensive upfront, Feraheme's rapid action and better tolerability can lead to reduced hospitalization and treatment costs, offering overall economic benefits.

3. What future indications could expand Feraheme’s market?
Potential indications include anemia associated with inflammatory bowel disease, chemotherapy-induced anemia, and pediatric iron deficiency anemia.

4. How might biosimilars impact Feraheme's financial trajectory?
Biosimilar entries could lead to pricing pressures, reducing margins and market share unless Feraheme distinguishes itself through clinical benefits or cost advantages.

5. What emerging regions hold the most promise for Feraheme?
The Asia-Pacific region, driven by high CKD burden and expanding healthcare infrastructure, offers substantial growth opportunities.

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References:

[1] EvaluatePharma. "IV Iron Market Analysis." 2022.
[2] KDIGO Clinical Practice Guidelines for Anemia Management. 2012.
[3] IQVIA. "Global Hematology/Oncology Drug Forecast." 2021.
[4] U.S. FDA. Feraheme Prescribing Information. 2009.
[5] MarketWatch. "IV Iron Therapy Global Market Outlook." 2022.