Ferric carboxymaltose - Generic Drug Details

What are the generic sources for ferric carboxymaltose and what is the scope of freedom to operate?

Ferric carboxymaltose is the generic ingredient in one branded drug marketed by Am Regent and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ferric carboxymaltose has seventy-one patent family members in thirty-two countries.

There are two drug master file entries for ferric carboxymaltose. One supplier is listed for this compound.

Summary for ferric carboxymaltose

International Patents:	71
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	141
Patent Applications:	183
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ferric carboxymaltose
DailyMed Link:	ferric carboxymaltose at DailyMed

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

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

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 ferric carboxymaltose

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

Sponsor	Phase
Association for the Advancement of Blood & Biotherapies	PHASE2
Columbia University	PHASE2
Fundacion Clinic per a la Recerca Biomdica	PHASE3

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
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022		RX	Yes	Yes
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022		RX	Yes	Yes
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021		RX	Yes	Yes

Expired US Patents for ferric carboxymaltose

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021

International Patents for ferric carboxymaltose

Country	Patent Number	Title	Estimated Expiration
Mexico	PA05004300	COMPLEJOS DE HIERRO-CARBOHIDRATO SOLUBLES EN AGUA, PRODUCCION DE LOS MISMOS, Y MEDICAMENTOS QUE LOS CONTIENEN. (WATER-SOLUBLE IRON-CARBOHYDRATE COMPLEXES, PRODUCTION THEREOF, AND MEDICAMENTS CONTAINING SAID COMPLEXES.)
Japan	2006505638
Jordan	3286	متراكبات مائية من حديد و كربوهيدرات,انتاجها و ادوية تحتوي عليها (AQUEOUS IRON CARBOHYDRATE COMPLEXES,THEIR PRODUCTION AND MEDICAMENTS CONTAINING THEM)

Supplementary Protection Certificates for ferric carboxymaltose

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 the Pharmaceutical Drug: FERRIC CARBOXYMALTOSE

Last updated: November 3, 2025

---

Introduction

Ferric Carboxymaltose (FCM) is an intravenous iron formulation widely utilized to treat iron deficiency anemia (IDA), especially in cases where oral iron therapy proves ineffective or is contraindicated. Its unique pharmacological profile—rapid iron delivery and favorable safety profile—has bolstered its adoption across global healthcare markets. As the demand for effective anemia treatments intensifies, understanding the market dynamics and financial prospects of Ferric Carboxymaltose becomes essential for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

---

Market Overview and Growth Drivers

1. Rising Prevalence of Iron Deficiency Anemia (IDA):
IDA affects over 1.6 billion individuals globally, with higher prevalence in pregnant women, children, chronic disease patients, and the elderly [1]. This pervasive health condition drives demand for efficacious iron replacement therapies. Ferric Carboxymaltose's FDA and EMA approvals have elevated its profile as a preferred IV iron option, particularly in complex anemia cases.

2. Limitations of Oral Iron Therapy:
Oral iron supplements often induce gastrointestinal side effects, poor compliance, and in certain conditions like inflammatory bowel disease or chronic kidney disease (CKD), absorption issues render oral therapy ineffective. FCM’s rapid infusion capabilities and minimal GI side effects position it favorably among healthcare providers.

3. Advancements in IV Iron Formulations:
The transition from older, high-molecular-weight iron dextrans to newer formulations like FCM underscores technological evolution that enhances safety, efficacy, and administration convenience. This progress sustains FCM’s market relevance.

4. Expanding Indications and Clinical Evidence:
Beyond IDA, FCM is increasingly used for anemia management in CKD, cancer-related anemia, and perioperative settings [2]. Growing clinical evidence facilitates regulatory approvals and formulary inclusion, expanding its market access.

5. Healthcare Infrastructure and Urbanization:
Developed nations with advanced healthcare systems regularly incorporate IV iron therapies into anemia protocols. Emerging markets, buoyed by urbanization and increasing healthcare expenditure, are gradually adopting FCM.

---

Market Challenges and Constraints

1. Cost Considerations:
Compared to oral iron, FCM’s higher drug and administration costs can impede widespread adoption, especially in low- and middle-income economies. Reimbursement policies and insurance coverage significantly influence market penetration.

2. Competition:
Ferroliquid products like iron sucrose, iron dextran, and next-generation formulations such as Ferumoxytol and Fitusiran compete directly. Differentiation hinges on efficacy, safety, dosing convenience, and cost.

3. Regulatory and Safety Concerns:
While generally safe, rare hypersensitivity reactions and anaphylaxis have been reported. Strict adherence to administration protocols remains critical, influencing provider comfort and utilization rates.

4. Licensing and Patent Expiry Risks:
Patent protections for FCM are nearing expiration in some markets, risking generic entry and price erosion, potentially affecting profit margins.

---

Financial Trajectory and Revenue Outlook

1. Market Size and Forecasts:
According to a recent report by Grand View Research, the global market for IV iron therapies, led by FCM, was valued at approximately USD 2.4 billion in 2021, with projections to reach USD 4.3 billion by 2030, growing at a CAGR of 7.4% [3]. FCM accounts for a significant share due to its widespread approval and clinical endorsement.

2. Geographic Market Dynamics:

• North America: Leading the market owing to high prevalence of CKD, robust healthcare infrastructure, and strong regulatory support. The U.S. remains the largest market, with the FDA's approvals (notably for IDA and CKD) propelling growth.
• Europe: Mature market with extensive penetration; pre-existing clinical guidelines favor IV iron therapies.
• Asia-Pacific: Fastest-growing segment owing to rising anemia prevalence, increasing healthcare spending, and expanding healthcare access. Countries like China, India, and Japan are seeing burgeoning adoption.
• Latin America & MEA: Growing markets driven by increasing awareness and infrastructural development.

3. Revenue Streams and Pricing Strategies:
Revenue generation depends on per-dose pricing, frequency of administration, and patient volume. In regions with reimbursement frameworks, FCM's higher costs are mitigated, encouraging uptake. Strategies such as bundled payments and value-based care models further influence profitability.

4. Impact of Patent Expirations and Generics:
The expiration of patents in select markets could introduce generic alternatives, compress pricing but expand volume sales. Companies are increasingly investing in differentiated formulations and combination therapies to sustain revenues.

5. R&D and Pipeline Prospects:
Leverage of innovative formulations and combination regimens, along with new indications like inflammatory bowel disease and oncology-related anemia, signal diversified revenue avenues. Collaborations with biotech firms aimed at developing next-generation IV iron products could alter financial trajectories.

---

Market Dynamics: Opportunities and Strategic Outlook

Opportunities:

• Expansion into Emerging Markets: Tailored pricing and local manufacturing could accelerate penetration.
• Integration into Treatment Protocols: Demonstrating cost-effectiveness and improved patient outcomes fosters formulary inclusion.
• Combination Therapies: Combining FCM with other therapeutics to address multifactorial anemia enhances value propositions.
• Digital and Telehealth Adoption: Facilitating outpatient infusion services and remote monitoring can improve accessibility.

Challenges:

• Price sensitivity in resource-limited settings necessitates strategic pricing.
• Competition may intensify with the entry of biosimilar and alternative formulations.
• Ensuring safety and clinician confidence requires ongoing post-market surveillance and education.

---

Key Takeaways

• Steady Market Growth: The global IV iron market, led by Ferric Carboxymaltose, is expected to expand at approximately 7.4% CAGR through 2030, driven by increasing anemia prevalence and expanding indications.
• Geographic Diversification: North America and Europe currently dominate, but Asia-Pacific presents significant future growth prospects.
• Market Dynamics: Cost, competition, safety profile, and regulatory changes are pivotal. Strategic pricing, clinical education, and pipeline innovation remain critical.
• Financial Outlook: Revenues are poised for sustainable growth amid patent expirations and competitive pressures, especially if manufacturers can innovate and expand into new therapeutic areas.
• Stakeholder Strategies: Core success factors include expanding access, demonstrating cost-effectiveness, and building clinical confidence.

---

FAQs

1. What factors influence the adoption of Ferric Carboxymaltose globally?
Clinical efficacy, safety profile, reimbursement policies, cost considerations, and physician familiarity primarily influence adoption rates.

2. How does Ferric Carboxymaltose compare to other IV iron formulations?
FerriCarboxymaltose offers rapid repletion, high dosing flexibility, and a favorable safety profile compared to older formulations like iron dextran or iron sucrose, which may require multiple infusions or have higher risks of hypersensitivity.

3. What is the impact of patent expiration on the Ferric Carboxymaltose market?
Patent expiry may lead to generic competition, potentially reducing prices but increasing market volume. This can impact profit margins but also expands access.

4. Are there upcoming indications for Ferric Carboxymaltose that could influence its market trajectory?
Yes, ongoing research explores its role in non-anemic iron deficiency, heart failure, and cancer-related anemia, which could broaden its therapeutic use.

5. How can pharmaceutical companies sustain growth amid increasing competition?
Through innovation, expanding indications, cost management strategies, enhancing safety profiles, and forging strategic partnerships in emerging markets.

---

References:

[1] World Health Organization. (2021). Iron deficiency anemia prevalence and health impact.
[2] European Medicines Agency. (2017). Summary of Product Characteristics for Ferric Carboxymaltose.
[3] Grand View Research. (2022). Intravenous Iron Market Size, Share & Trends Analysis.