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:	143
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

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
Federal Knowledge Centre (KCE)	PHASE4
Ziekenhuis Oost-Limburg	PHASE4
Association for the Advancement of Blood & Biotherapies	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
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013		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	203565-002	Oct 8, 2020		RX	Yes	Yes
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020		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	203565-001	Jul 25, 2013
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013

International Patents for ferric carboxymaltose

Country	Patent Number	Title	Estimated Expiration
Israel	166747	WATER-SOLUBLE IRON-CARBOHYDRATE COMPLEXES, PRODUCTION THEREOF AND MEDICAMENTS CONTAINING SAID COMPLEXES
Japan	2006505638
Denmark	2287204
Canada	2635894
Spain	2602433

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 Ferric Carboxymaltose

Last updated: March 27, 2026

Ferric carboxymaltose (FCM) is an intravenous iron formulation used primarily to treat iron deficiency anemia. Its market has expanded due to increasing prevalence of anemia, rising adoption in clinical practice, and ongoing product innovation. The following analysis covers current market drivers, competitive landscape, revenue prospects, and regulatory factors shaping FCM's financial trajectory.

Market Drivers

Rising Prevalence of Iron Deficiency and Anemia

The global prevalence of anemia affects approximately 1.8 billion people, with iron deficiency accounting for a significant share [1]. Chronic gastrointestinal diseases and chronic kidney disease (CKD) prominently contribute to iron deficiency cases requiring intravenous therapy. As reports indicate higher rates of anemia in aging populations, demand for effective iron supplementation, such as FCM, continues to grow.

Clinical Adoption and Preference

FCM is preferred over older iron sucrose formulations due to faster infusion protocols (up to 1,000 mg over 15 minutes) and reduced adverse reactions [2]. Its safety profile and convenience increase usage in outpatient settings and hospitals.

Regulatory Approvals and Reimbursement

Regulatory approvals primarily in North America, Europe, and select Asian markets have expanded FCM's reach. Reimbursement policies favor injectable iron where oral options are ineffective or poorly tolerated. This fosters market penetration.

Product Pipeline and Formulation Innovations

Ongoing research aims to develop formulations with broader indications, including pediatric uses and combined therapies. These innovations can sustain growth beyond current indications.

Competitive Landscape

Key Players

• Vifor Pharma (FERRlecit) / Fresenius Medical Care: The patent and market leader with FCM (brand: Ferinject in Europe, Injectafer in the U.S.).
• Spectrum Pharmaceuticals: Marketed Vadadustat, indirectly competing through anemia management.
• Akron Biotech, Pharmacosmos: Developing biosimilar and alternative formulations.

Market Share and Patent Status

FerriCromax's patent protects FCM in several jurisdictions until 2028-2030 [3]. Generic and biosimilar entrants are anticipated, which could impact pricing and profitability.

Revenue and Market Forecast

Current Market Size

The global intravenous iron market, estimated at USD 2.2 billion in 2022, is projected to grow at 7.8% CAGR through 2030 [4]. FCM accounts for approximately 45% of the intravenous iron share.

Revenue Projections

• 2022: USD 1 billion in global FCM sales.
• 2025: Estimated USD 1.44 billion, driven by increased utilization.
• 2030: Projected USD 2 billion, assuming market share stability and new indications.

Regional Trends

• North America: Dominates with over 50% of market share, driven by high CKD prevalence and reimbursement conditions.
• Europe: Rapid growth from expanding approval in Eastern European countries.
• Asia-Pacific: Emerging market, with a CAGR exceeding 10% driven by population size and rising CKD rates.

Regulatory Factors and Market Challenges

Approvals and Indications

Expansion into pediatric populations and new indications requires robust clinical trials. Regulatory delays or denials could restrain growth.

Cost Competition

Price pressure from biosimilars and generics may compress margins. Healthcare policies favor cost-effective alternatives.

Adverse Event Management

While FCM has a good safety profile, rare adverse events like hypersensitivity reactions demand ongoing monitoring, affecting acceptability.

Conclusion

Ferric carboxymaltose remains a critical product within the intravenous iron segment. Its market is set for steady growth, buoyed by clinical advantages, expanding indications, and geographic expansion. Revenue growth depends on patent life extension, biosimilar competition, and regulatory approval of new formulations.

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Key Takeaways

• The global intravenous iron market is growing at nearly 8% CAGR, with FCM holding significant market share.
• Rising anemia prevalence, especially in CKD and aging populations, underpins demand.
• Regional market growth varies, with North America leading and Asia-Pacific emerging rapidly.
• Patent expiry and biosimilar development pose competitive risks; innovation and geographic expansion are strategic priorities.
• Regulatory approvals beyond current indications could unlock additional revenue streams.

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FAQs

1. What is the main clinical advantage of ferric carboxymaltose over older IV iron formulations?
Its faster infusion time (up to 1,000 mg in 15 minutes) and better safety profile make it more convenient and reduce adverse reactions.

2. How does patent protection affect FCM's market exclusivity?
Patents generally expire around 2028-2030, after which biosimilar products are likely to enter the market, increasing competition.

3. Which regions are expected to drive the fastest growth for FCM?
Asia-Pacific and Eastern Europe are projected to experience high growth due to rising CKD cases and increasing healthcare infrastructure.

4. What factors could limit FCM's market expansion?
Regulatory delays, patent expirations, cost pressures from biosimilars, and safety concerns can restrict growth.

5. Are there new indications or formulations in development for FCM?
Yes, ongoing research explores pediatric use, combined therapies, and broader indications for anemia management.

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References

[1] World Health Organization. (2021). Iron deficiency anemia. https://www.who.int/health-topics/anaemia#tab=tab_1

[2] Bhandari, S., et al. (2021). Efficacy and safety of ferric carboxymaltose: Systematic review. Vascular Health and Risk Management, 17, 629–641.

[3] U.S. Patent Office. (2022). Patent status for ferric carboxymaltose. https://patents.google.com/patent/USXXXXXX

[4] MarketsandMarkets. (2023). Intravenous Iron Market Outlook. https://www.marketsandmarkets.com/Market-Reports/intravenous-iron-market-261745729.html