injectafer Drug Patent Profile

Which patents cover Injectafer, and when can generic versions of Injectafer launch?

Injectafer is a drug marketed by Am Regent and is included in one NDA. There are six patents protecting this drug and four Paragraph IV challenges.

This drug has seventy-one patent family members in thirty-two countries.

The generic ingredient in INJECTAFER is ferric carboxymaltose. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric carboxymaltose profile page.

DrugPatentWatch^® Generic Entry Outlook for Injectafer

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 31, 2026. This may change due to patent challenges or generic licensing.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for injectafer

International Patents:	71
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	23
Drug Prices:	Drug price information for injectafer
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for injectafer
What excipients (inactive ingredients) are in injectafer?	injectafer excipients list
DailyMed Link:	injectafer at DailyMed

See drug prices for injectafer

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for injectafer

Constraining patent/regulatory exclusivity:

TREATMENT OF IRON DEFICIENCY IN ADULT PATIENTS WITH HEART FAILURE AND NEW YORK HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY

NDA:

203565

Dosage:

INJECTABLE;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for injectafer

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

Sponsor	Phase
Guangzhou Jeeyor Medical Research Co.,Ltd.	PHASE1
The First Hospital of Jilin University	PHASE1
Boji Medical Technology Co., Ltd.	PHASE1

See all injectafer clinical trials

Pharmacology for injectafer

Drug Class	Parenteral Iron Replacement Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

Paragraph IV (Patent) Challenges for INJECTAFER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INJECTAFER	Injection	ferric carboxymaltose	500 mg/10 mL	203565	1	2024-02-22
INJECTAFER	Injection	ferric carboxymaltose	100 mg/2 mL	203565	1	2022-09-23
INJECTAFER	Injection	ferric carboxymaltose	1 g/20 mL	203565	1	2022-02-15
INJECTAFER	Injection	ferric carboxymaltose	750 mg/15 mL	203565	1	2019-03-27

US Patents and Regulatory Information for injectafer

injectafer is protected by twenty-six US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on TREATMENT OF IRON DEFICIENCY IN ADULT PATIENTS WITH HEART FAILURE AND NEW YORK HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020		RX	Yes	Yes	11,433,091
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes	11,433,091
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022		RX	Yes	Yes	11,478,502
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes	7,754,702
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes	11,478,502

Expired US Patents for injectafer

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022	11,291,645
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020	11,590,097
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021	11,123,321
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013	11,590,097
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013	9,376,505

International Patents for injectafer

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

Country	Patent Number	Title	Estimated Expiration
Australia	2007205167
Hungary	E029259
South Africa	200504174	Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes
South Korea	100992178
Brazil	PI0318840	complexo de carboidrato de ferro (iii) hidrossolúvel e uso do mesmo

Supplementary Protection Certificates for injectafer

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1554315	C01554315/01	Switzerland		PRODUCT NAME: EISEN ALS EISENCARBOXYMALTOSE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 57851 10.11.2022

Market Dynamics and Financial Trajectory for Injectafer (Ferumoxytol)

Last updated: December 29, 2025

Summary

Injectafer, the trade name for ferumoxytol, is a vital intravenous (IV) iron replacement therapy predominantly used for treating iron deficiency anemia in adults with chronic kidney disease (CKD). Over recent years, its market has experienced notable growth driven by rising prevalence of CKD, improved healthcare access, and expanding indications, including off-label uses. This report explores the current market landscape, key drivers, challenges, financial trajectories, and future outlooks for Injectafer, integrating quantitative data, competitive positioning, and regulatory insights to guide stakeholders.

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Introduction

Injectafer, developed by American Regent Inc., received FDA approval in 2009 for iron deficiency anemia in patients with CKD. Its unique formulation—ferumoxytol, an ultrasmall superparamagnetic iron oxide nanoparticle—provides rapid iron replenishment and is administered in less frequent doses, making it a preferred choice over traditional iron therapies.

The global iron deficiency anemia (IDA) market is projected to reach USD 17.4 billion by 2027, with IV iron therapies constituting a significant portion. Injectafer’s share hinges on clinical efficacy, safety profile, regulatory acceptance, and competitive positioning.

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Market Dynamics: Key Drivers

1. Rising Prevalence of Chronic Kidney Disease and Anemia

Factor	Details	Quantitative Data
CKD Prevalence Worldwide	Estimated to affect over 850 million people globally	Growing at 8% annually (CDC, 2022)[1]
Anemia in CKD Patients	Affects up to 50% of CKD patients	Drives demand for IV iron therapies

Impact:
The increasing CKD population, especially in aging demographics, correlates with heightened anemia incidence, escalating demand for injectable iron products like Injectafer.

2. Advantages Over Traditional Iron Therapies

• Rapid repletion with fewer doses
• Lower risk of allergic reactions relative to older IV irons
• Ability to administer in outpatient settings

3. Expanding Indications and Off-label Use

Recent studies indicate potential off-label uses including:

• Iron deficiency anemia in oncology and gastrointestinal disorders
• Use in preoperative anemia management

Regulatory Developments:
FDA approval for specific off-label protocols enhances market occupancy.

4. Healthcare Access and Policy

• Favorable reimbursement policies in the US (Medicare, private insurers)
• Increasing utilization due to outpatient infusion flexibility

5. Competitive Landscape

Competitors	Key Differentiators	Market Share (Approximate, 2022)
Ferrlecit (sodium ferric gluconate)	Traditional IV iron, cheaper	30%
Venofer (iron sucrose)	Well-established, broader use	25%
Ferinject (ferric carboxymaltose)	Higher dose, convenience	20%
Injectafer (ferumoxytol)	Rapid infusion, novel agent	25%

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Financial Trajectory: Revenue and Market Penetration

Historical Revenue Growth

Year	Global Revenue (USD millions)	YoY Growth	Notes
2018	350	—	Launch phase for expanded indications
2019	420	20%	Uptake in CKD patients increases
2020	480	14%	COVID-19 impact mitigated through outpatient adoption
2021	560	16.7%	Increased off-label use and approvals
2022	620	10.7%	Stabilization; market competition intensifies

Source: Company financial reports and industry estimates.

Forecasted Revenue (2023–2027)

Year	Predicted Revenue (USD millions)	CAGR (Compound Annual Growth Rate)	Drivers
2023	680	10%	Market expansion; new indications
2024	750	10.3%	Increased awareness and off-label use
2025	835	11.3%	Regulatory approvals in additional regions
2026	935	12%	Emerging markets infusion
2027	1045	11.7%	Market saturation in mature markets

Market Share Dynamics

Injectafer's share is expected to stabilize around 25%, with growth driven by expansion in North America and Europe.

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Regulatory and Policy Impact

Pricing and Reimbursement Policies

• US: Reimbursed via Medicare, Medicaid, and private insurers with favorable coding (e.g., HCPCS codes) for outpatient infusion.
• Europe: Varying reimbursement policies; approvals granted in UK, Germany, and France.

Regulatory Challenges

• Stringent safety monitoring mandated due to rare adverse events such as hypersensitivity reactions.
• Ongoing post-marketing surveillance maintains market confidence.

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Competitive Positioning and Differentiators

Aspect	Injectafer (Ferumoxytol)	Ferinject (Ferric Carboxymaltose)	Venofer (Iron Sucrose)	Ferrlecit (Sodium Ferric Gluconate)
Dosing	510 mg per dose (fixed)	500–1000 mg in single dose	100 mg per dose	62.5 mg per dose
Infusion Time	~15 seconds	15–20 minutes	20 minutes	15 minutes
Indications	CKD, off-label	CKD, anemia	CKD, anemia	CKD, anemia
Price per Dose	~$300–$400	~$350	~$50	~$20

Note: Market leaders compete on dosing convenience and cost.

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Insights into Future Growth and Innovation

Emerging Trends

• Personalized Medicine: Biomarker-guided therapy optimization.
• Combination Therapies: Integrating iron therapies with erythropoiesis-stimulating agents (ESAs).
• Digital and Remote Monitoring: Enhancing infusion safety and compliance.
• New Formulations: Development of longer-acting and higher-dose formulations.

Research & Development Outlook

• Potential pipeline expansion to treat iron deficiency other than CKD, e.g., chemotherapy-induced anemia.
• Patent protection set to expire around 2030, opening avenues for biosimilars.

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Challenges and Risks

Risk Factor	Implication
Competitive pressure	Marginalizes market share if competitors innovate faster
Safety concerns	Adverse events may limit utilization
Regulatory hurdles	Restrictions could impede expansion
Price sensitivity	Market shift to cheaper alternatives

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Key Takeaways

• Rapid Market Growth: Driven predominantly by CKD prevalence, with injectables like Injectafer leading due to efficacy and safety profile.
• Financial Outlook: Steady growth with an estimated CAGR of 10–12% through 2027; revenues nearing USD 1.05 billion.
• Competitive Edge: Unique dosing advantages and expanding indications reinforce market position.
• Regulatory & Policy Influence: Favorable reimbursement supports financial trajectory, though vigilance on safety monitoring remains critical.
• Innovation Focus: Future success hinges on pipeline development, expanding indications, and leveraging personalized medicine.

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FAQs

1. What are the main advantages of Injectafer over other IV iron therapies?

Injectafer offers rapid infusion times (~15 seconds per dose), higher dosing per administration, and a lower risk of hypersensitivity reactions, making it convenient and safer for outpatient settings compared to older agents like iron sucrose or ferric gluconate.

2. How does the patent landscape influence Injectafer’s market longevity?

While core patents are expected to expire around 2030, market dominance will depend on regulatory approvals, safety profiles, and potential biosimilar entrants. Patent expiry may lead to increased competition but also encourages innovation.

3. What is the geographic distribution of Injectafer’s sales?

Primarily sold in North America, with expansion into Europe and select Asia-Pacific markets. Policy differences and reimbursement practices influence regional market penetration.

4. How is safety monitored for Injectafer, and what are common adverse effects?

Post-marketing surveillance tracks hypersensitivity and infusion-related reactions. Common adverse effects include headache, nausea, and hypotension. Safety remains a key component of market confidence.

5. What potential off-label uses could expand Injectafer’s market?

Emerging evidence suggests use in iron deficiency management in gastrointestinal and oncological settings, as well as preoperative anemia correction—pending regulatory approval.

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References

[1] Centers for Disease Control and Prevention (CDC). "Chronic Kidney Disease in the United States, 2022."
[2] American Regent Inc. Financial Reports, 2018–2022.
[3] MarketResearch.com. "Global Iron Deficiency Anemia Market Forecast," 2022.
[4] FDA Device Approvals and Safety Communications.
[5] European Medicines Agency. "Regulatory decisions on ferumoxytol," 2021.

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In conclusion, Injectafer’s market trajectory demonstrates promising growth supported by demographic trends, clinical advantages, and expanding indications. Strategic positioning—embracing innovation, navigating regulatory landscapes, and strengthening competitive differentiation—will be critical to capitalizing on its full commercial potential in the evolving anemia treatment landscape.