FERRIC CARBOXYMALTOSE Drug Patent Profile

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

Ferric Carboxymaltose is a drug marketed by Mylan and Mylan Labs Ltd and is included in three NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ferric Carboxymaltose

A generic version of FERRIC CARBOXYMALTOSE was approved as ferric carboxymaltose by MYLAN on June 25^th, 2026.

Summary for FERRIC CARBOXYMALTOSE

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	143
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FERRIC CARBOXYMALTOSE
What excipients (inactive ingredients) are in FERRIC CARBOXYMALTOSE?	FERRIC CARBOXYMALTOSE excipients list
DailyMed Link:	FERRIC CARBOXYMALTOSE at DailyMed

Recent Clinical Trials for FERRIC CARBOXYMALTOSE

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

Sponsor	Phase
Ziekenhuis Oost-Limburg	PHASE4
Federal Knowledge Centre (KCE)	PHASE4
Columbia University	PHASE2

See all FERRIC CARBOXYMALTOSE clinical trials

Pharmacology for FERRIC CARBOXYMALTOSE

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

Paragraph IV (Patent) Challenges for FERRIC CARBOXYMALTOSE

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 FERRIC CARBOXYMALTOSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	FERRIC CARBOXYMALTOSE	ferric carboxymaltose	SOLUTION;INTRAVENOUS	217076-001	Jun 25, 2026	AP	RX	No	No
Mylan	FERRIC CARBOXYMALTOSE	ferric carboxymaltose	SOLUTION;INTRAVENOUS	217769-001	Jun 25, 2026	AP	RX	No	No
Mylan Labs Ltd	FERRIC CARBOXYMALTOSE	ferric carboxymaltose	SOLUTION;INTRAVENOUS	212572-001	Jun 25, 2026	AP	RX	No	No

Ferric Carboxymaltose Market Dynamics, Revenue Outlook, Patents, and Competitive Risk

Last updated: October 1, 2026

Ferric carboxymaltose is a leading high-dose intravenous iron product sold primarily as Ferinject in Europe and Injectafer in the United States. Its commercial position rests on fewer infusion visits, broad use in iron-deficiency anemia, chronic kidney disease, heart failure, and inflammatory conditions, and strong physician familiarity. The market is shifting from branded expansion to lifecycle management as core composition patents age, competing intravenous irons gain adoption, and hypophosphatemia concerns influence prescribing.

CSL Vifor remains the principal global rights holder through Ferinject and related commercial arrangements. Daiichi Sankyo’s American Regent markets Injectafer in the United States. Public companies do not report ferric carboxymaltose revenue consistently as a standalone line item, so financial analysis depends on product-level disclosures, regional sales commentary, and aggregate CSL Vifor results.

What is ferric carboxymaltose and how is it used?

Ferric carboxymaltose is an intravenous iron-carbohydrate complex used to replenish iron stores rapidly. It is administered in relatively large doses, reducing the number of infusion visits compared with iron sucrose and some other intravenous iron products.

Major commercial brands include:

Brand	Principal market	Commercial rights or marketer
Injectafer	United States	American Regent, a Daiichi Sankyo company
Ferinject	Europe and numerous international markets	CSL Vifor and regional partners
Ferric carboxymaltose injection	Generic markets	Various manufacturers after regulatory approval

The product is used for patients with iron-deficiency anemia who cannot tolerate oral iron, have an inadequate response to oral iron, or require rapid iron repletion. It is also used in non-dialysis-dependent chronic kidney disease and in selected heart-failure populations, depending on the jurisdiction and label.

The principal clinical advantages are dose convenience and reduced administration burden. The principal safety concern is hypophosphatemia, particularly with repeated dosing and in patients with certain risk factors. The U.S. prescribing information includes a warning concerning symptomatic hypophosphatemia and monitoring of serum phosphate in patients receiving repeat treatment or at elevated risk [1].

What is the FDA and European regulatory status of Injectafer and Ferinject?

Injectafer received U.S. Food and Drug Administration approval in 2013 for adults with iron-deficiency anemia who were intolerant of or had an unsatisfactory response to oral iron, and for adults with non-dialysis-dependent chronic kidney disease. Subsequent label expansions broadened the addressable patient population, including pediatric use and additional heart-failure-related populations.

Ferinject received European authorization earlier and has a broader, mature international regulatory footprint. European labeling generally permits high-dose administration, subject to country-specific implementation and clinical restrictions.

Regulatory milestone	Product	Significance
2007	Ferinject in Europe	Established the first major commercial market for ferric carboxymaltose
2013	Injectafer in the United States	Opened the largest branded opportunity for the product
2020	U.S. label expansion	Added non-dialysis-dependent chronic kidney disease
2021 onward	Further U.S. population expansions	Increased use in pediatric and specialty-care settings
2023 onward	Heart failure-related use expansion	Supported demand in cardiology and hospital channels

The regulatory opportunity is strongest where treatment guidelines support intravenous iron before transfusion, during chronic disease management, or in heart failure with iron deficiency. The product is less advantaged in settings where low-cost iron sucrose is clinically adequate and infusion capacity is available.

How large is the ferric carboxymaltose market?

Ferric carboxymaltose is one of the largest branded intravenous iron franchises globally. Market research estimates vary materially because some reports measure the entire intravenous iron market, while others isolate ferric carboxymaltose or include hospital purchasing, distributor revenue, and retail sales differently.

The addressable market is supported by several structural factors:

1. Iron-deficiency anemia remains common across women of reproductive age, pregnancy, gastrointestinal disease, chronic kidney disease, cancer, and inflammatory disorders.
2. Oral iron has adherence and tolerability limitations.
3. Hospitals and infusion centers value products that deliver a high iron dose in one or two visits.
4. Heart failure guidelines and clinical evidence have increased screening and treatment of iron deficiency.
5. Chronic kidney disease and oncology care generate recurring treatment demand.

The market faces countervailing pressure from lower-priced intravenous iron products, biosimilar-like competition involving iron-carbohydrate complexes, formulary controls, and efforts to manage hypophosphatemia risk.

Market segmentation by treatment setting

Segment	Demand profile	Commercial outlook
Chronic kidney disease	Recurring use, nephrology-driven	Stable, but exposed to formulary substitution
Heart failure	Growth linked to screening and guideline adoption	Major expansion opportunity
Obstetrics and gynecology	High prevalence of iron deficiency	Strong use where rapid correction is needed
Gastroenterology	Demand from inflammatory bowel disease and malabsorption	Durable specialty opportunity
Oncology	Supportive care and anemia management	Variable, tied to treatment pathways
General hospital and outpatient infusion	High volume and protocol-driven	Price competition is strongest

What is the financial trajectory for ferric carboxymaltose?

The commercial trajectory has moved through three stages: initial market creation, label-driven expansion, and mature-franchise defense.

During the first stage, Ferinject and Injectafer benefited from differentiation against iron sucrose and other products requiring multiple visits. The second stage was driven by U.S. label expansions, broader specialty adoption, and increased evidence in heart failure. The current stage depends more heavily on maintaining price, defending formulary position, expanding diagnosis rates, and managing generic competition.

CSL’s acquisition of Vifor Pharma for approximately $11.7 billion closed in 2022. The transaction gave CSL control of a global portfolio centered on iron products, including Ferinject, and strengthened its specialty pharmaceutical platform [2]. CSL reports Vifor-related revenue at the segment or portfolio level rather than providing a complete, recurring standalone Ferinject revenue series.

Financial factor	Effect on ferric carboxymaltose
High-dose convenience	Supports premium pricing over iron sucrose
U.S. market maturity	Limits volume growth in established accounts
Heart failure expansion	Creates incremental volume and physician demand
Generic entry	Creates price and share pressure
Hypophosphatemia monitoring	May shift use toward competing products
CSL ownership	Supports global coordination and lifecycle investment
American Regent distribution	Maintains U.S. commercial reach for Injectafer

Injectafer has been a material product for American Regent, but American Regent is privately held and does not provide a detailed public revenue history for the brand. CSL’s public reporting provides a better view of the global franchise, although the company’s disclosures combine Ferinject with other Vifor products in some periods [3].

The likely financial pattern is declining growth in mature Western European markets, continued resilience in the United States, and higher growth potential in emerging markets where intravenous iron penetration remains lower. Net pricing is likely to become more important than unit growth as generic and competing branded products gain access.

When does ferric carboxymaltose lose exclusivity?

The core ferric carboxymaltose composition and manufacturing patent estate was filed more than two decades ago. The commercial exclusivity period for the original active complex has therefore substantially matured in major jurisdictions.

The key U.S. patent families associated with ferric carboxymaltose and iron-carbohydrate complexes include patents assigned to Vifor-related entities, including:

Patent or patent family	Subject matter	Commercial relevance
U.S. Patent No. 7,754,702	Iron-carbohydrate complex technology	Core composition and product protection
Related continuation and international families	Iron complexes, preparation, and pharmaceutical use	Potentially extended protection in selected jurisdictions
Later formulation and method-of-use families	Administration, dosing, and clinical use	More limited protection than the core product patents

Patent term, terminal disclaimers, patent-term adjustment, and Orange Book listing status must be assessed by jurisdiction and patent family. The practical issue is that the principal product technology is mature, while later patents may protect dosing, formulations, or specific uses rather than the entire ferric carboxymaltose molecule.

What patents protect Injectafer and Ferinject?

Protection historically has relied on four layers:

Core composition patents

These patents cover iron-carbohydrate complexes with defined structural or physicochemical characteristics. They formed the primary barrier to direct competition during the launch period.

Manufacturing patents

Manufacturing claims can cover the preparation of the iron-carbohydrate complex, control of molecular weight, carbohydrate-to-iron ratios, reaction conditions, purification, and stability. These claims can create a technical barrier even after basic composition patents expire.

Formulation patents

Formulation protection can cover concentration, pH, excipients, container systems, stability profiles, and ready-to-use injectable presentations. Such patents usually provide narrower protection than the core composition estate.

Method-of-use patents

Use patents may cover treatment of iron deficiency in chronic kidney disease, heart failure, inflammatory disease, pediatric populations, or patients requiring defined dosing schedules. These patents can support litigation against a generic applicant that seeks approval for a patented indication, but they may not prevent approval for non-infringing uses.

The practical strength of the estate is therefore mixed. The original product has strong historical validation and manufacturing complexity, but age of the core technology reduces long-term exclusionary power. Later patents have greater value when they map closely to high-volume indications and when the generic applicant seeks a broad label.

What is the Orange Book status of Injectafer?

Injectafer is approved under U.S. New Drug Application 022180. U.S. exclusivity analysis depends on current FDA Orange Book listings, patent certifications, pediatric exclusivity, and the scope of any approved label expansion.

The primary legal risks are:

• Paragraph IV certifications against listed patents.
• Section viii statements carving out protected indications.
• Patent litigation filed within 45 days of notice.
• FDA approval with a skinny label that excludes patented uses.
• Generic approval followed by commercial launch before resolution of all method-of-use disputes.

Because ferric carboxymaltose is a complex iron-carbohydrate product, regulatory substitution may require more than a conventional small-molecule bioequivalence showing. The FDA’s approval pathway depends on the reference product, product sameness, characterization, manufacturing controls, and the specific application filed by the competitor.

Which companies are challenging ferric carboxymaltose?

Competition comes from three groups.

Generic and follow-on ferric carboxymaltose manufacturers

Companies seeking approval for ferric carboxymaltose injection can compete directly with Injectafer once regulatory and patent barriers are cleared. Likely competitive advantages include lower acquisition cost, hospital contracting, and distributor access.

Alternative intravenous iron manufacturers

The most important alternatives include:

• Iron sucrose, marketed historically as Venofer.
• Ferric derisomaltose, marketed as Monoferric in the United States and Monofer in certain markets.
• Ferumoxytol, marketed as Feraheme.
• Low-molecular-weight iron dextran products.

Ferric derisomaltose is the closest branded competitor because it also supports large-dose administration and competes for outpatient infusion and chronic kidney disease use. Iron sucrose remains a significant price competitor, particularly in dialysis and hospital formularies.

Oral and emerging iron therapies

Oral iron remains the default for many patients because of cost and convenience. Newer oral products may compete for patients who would otherwise receive intravenous treatment, although tolerability and speed of repletion remain constraints.

How does ferric carboxymaltose compare with ferric derisomaltose?

Attribute	Ferric carboxymaltose	Ferric derisomaltose
Major brands	Injectafer, Ferinject	Monoferric, Monofer
High-dose administration	Yes	Yes
Main commercial advantage	Established brand, broad evidence base, global scale	High-dose dosing and lower hypophosphatemia concern in some comparative data
Main risk	Hypophosphatemia and mature patent estate	Smaller installed base and competitive pricing
Key channels	Nephrology, cardiology, infusion centers, hospitals	Nephrology, hematology, infusion centers
Strategic position	Incumbent leader	Principal branded challenger

Comparative clinical data have increased attention to hypophosphatemia. Studies have reported higher rates with ferric carboxymaltose than with ferric derisomaltose in certain populations, which may influence product selection and payer policy [4]. The commercial effect depends on whether clinicians treat the risk as a manageable monitoring issue or as a reason to select an alternative product.

What generic entry risks exist for Injectafer?

Generic entry could occur through several scenarios:

Scenario	Expected commercial effect
Narrow generic label	Limited immediate erosion, especially if major indications remain protected
Broad generic label after patent clearance	Rapid price compression and formulary substitution
One approved competitor	Moderate pressure, with contracting focused on large accounts
Multiple competitors	Steeper net-price decline and reduced brand leverage
Hospital-only entry	Volume loss concentrated in institutional accounts
Specialty-pharmacy entry	Greater exposure in outpatient and office-based infusion

The most important variable is not simply FDA approval. It is whether the entrant can obtain broad labeling, meet complex-product manufacturing requirements, secure payer coverage, and offer a meaningful discount. Iron products are often purchased through institutional contracts, so a competitor with limited clinical differentiation can still gain share through price.

What manufacturing and intellectual-property barriers remain?

Ferric carboxymaltose is more difficult to replicate than a conventional small molecule because its performance depends on the iron-carbohydrate complex, particle characteristics, molecular distribution, free iron control, stability, and injectable quality attributes.

Manufacturing barriers include:

• Control of iron release and carbohydrate structure.
• Reproducibility across commercial batches.
• Removal of unbound iron and process impurities.
• Stability during storage and transport.
• Sterility and particulate control.
• Demonstration of comparable clinical and physicochemical performance.

These barriers can delay competition, but they do not create permanent exclusivity. A well-capitalized generic manufacturer with iron-complex manufacturing expertise can convert the barriers into a development-cost issue rather than a long-term exclusionary moat.

What licensing deals affect ferric carboxymaltose?

The principal commercial structure is based on Vifor’s global rights and regional commercialization arrangements. CSL acquired Vifor in 2022, consolidating ownership of Ferinject and related iron assets [2].

In the United States, American Regent commercializes Injectafer under arrangements linked to Vifor. This structure gives the product local commercial scale while preserving the originator’s global control of the product technology and international brand.

Licensing economics are likely to change as exclusivity weakens. Before generic entry, the originator can support premium pricing and royalty flows. After entry, license value depends on geography, manufacturing access, authorized-generic strategy, and the ability to preserve hospital contracts.

What is the long-term market outlook for ferric carboxymaltose?

The franchise remains commercially durable but has entered a lower-growth phase. Volume can continue to expand through heart failure screening, chronic kidney disease treatment, and underdiagnosed iron deficiency. Price and market share will face pressure from ferric derisomaltose, iron sucrose, and generic ferric carboxymaltose.

The strongest defensive assets are:

• Broad physician familiarity.
• High-dose administration.
• Established safety and efficacy evidence.
• Global regulatory approvals.
• Manufacturing know-how.
• Hospital and specialty-care relationships.

The main vulnerabilities are:

• Aging composition patents.
• Hypophosphatemia concerns.
• Product-level generic competition.
• Payer preference for lower-cost intravenous iron.
• Limited public disclosure of standalone product economics.
• Dependence on continued clinical adoption in heart failure.

Key Takeaways

• Ferric carboxymaltose is a mature, globally established intravenous iron franchise led by Ferinject and Injectafer.
• CSL Vifor is the principal global rights holder following CSL’s acquisition of Vifor Pharma.
• American Regent, owned by Daiichi Sankyo, is the major U.S. commercial channel for Injectafer.
• Growth is shifting from initial market penetration toward heart failure, chronic kidney disease, and international expansion.
• The core patent estate is mature, increasing the importance of later formulation, manufacturing, and method-of-use patents.
• Generic entry is the largest medium-term threat to price and market share.
• Ferric derisomaltose is the closest branded competitor, while iron sucrose remains the strongest low-cost alternative.
• Hypophosphatemia risk is a material competitive issue and may support switching in selected patient populations.
• Public financial data do not consistently isolate ferric carboxymaltose revenue, requiring analysis of CSL Vifor portfolio disclosures and U.S. channel information.

FAQs

Is ferric carboxymaltose the same as Injectafer?

Yes. Injectafer is the U.S. brand for ferric carboxymaltose injection. Ferinject is the principal international brand.

Which intravenous iron has the lowest hypophosphatemia risk?

Comparative studies generally report lower hypophosphatemia rates with ferric derisomaltose than with ferric carboxymaltose, although risk depends on patient characteristics, dosing, baseline phosphate, and repeat exposure [4].

Can a generic company launch ferric carboxymaltose with a narrow label?

Yes. A generic applicant may seek approval with patented indications carved out through a Section viii statement, subject to FDA requirements and applicable patent litigation.

Does ferric carboxymaltose have biosimilar competition?

No. Ferric carboxymaltose is an iron-carbohydrate complex rather than a biologic. Competition generally proceeds through generic or follow-on injectable pathways, although product characterization can be more complex than for conventional small molecules.

Why does ferric carboxymaltose retain a premium over iron sucrose?

Its premium is mainly linked to higher-dose administration, fewer infusion visits, established clinical evidence, and reduced administration burden. The premium weakens when payers prioritize acquisition cost or when infusion capacity is not constrained.

References

1. U.S. Food and Drug Administration. (2023). Injectafer ferric carboxymaltose injection prescribing information. FDA.

2. CSL Limited. (2022). CSL completes acquisition of Vifor Pharma. CSL Limited.

3. CSL Limited. (2024). Annual report 2024. CSL Limited.

4. Wolf, M., Chertow, G. M., Macdougall, I. C., Kaper, R., Krop, J., & Strauss, W. (2020). Randomized trial of intravenous iron-induced hypophosphatemia. Journal of the American Society of Nephrology, 31(7), 1612-1624.

5. European Medicines Agency. (2024). Ferinject: European public assessment report. EMA.

6. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.