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:	128
Patent Applications:	105
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
Suzhou Guochen Biotek Co., Ltd.	Phase 1
Sichuan Huiyu Pharmaceutical Co., Ltd	Phase 1
Boji Medical Technology Co., Ltd.	Phase 1

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	7,754,702
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022		RX	Yes	Yes	11,433,091
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	7,612,109		Y	Y
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020		RX	Yes	Yes
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021		RX	Yes	Yes	7,754,702
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020		RX	Yes	Yes	7,612,109		Y	Y

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	11,590,097
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013	9,376,505
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021	11,123,321
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020	11,123,321
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022	11,590,097
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020	11,291,645
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013	11,291,645

International Patents for ferric carboxymaltose

Country	Patent Number	Title	Estimated Expiration
Lithuania	1973549
Canada	2953964	METHODES ET COMPOSITIONS POUR L'ADMINISTRATION DE FER (METHODS AND COMPOSITIONS FOR ADMINISTRATION OF IRON)
Malaysia	134394	AQUEOUS IRON CARBOHYDRATE COMPLEXES, THEIR PRODUCTION AND MEDICAMENTS CONTAINING THEM
European Patent Office	1973549	MÉTHODES ET COMPOSITIONS POUR L'ADMINISTRATION DE FER (METHODS AND COMPOSITIONS FOR ADMINISTRATION OF IRON)
South Korea	20050070014	WATER-SOLUBLE IRON-CARBOHYDRATE COMPLEXES, PRODUCTION THEREOF, AND MEDICAMENTS CONTAINING SAID COMPLEXES
Uruguay	28033	COMPLEJOS DE CARBOHIDRATO DE HIERRO ACUOSOS, SU PRODUCCION Y MEDICAMENTOS QUE LOS CONTIENEN
Hungary	E029259

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

Ferric carboxymaltose Market Analysis and Financial Projection Experimental

Ferric Carboxymaltose: Market Dynamics and Financial Trajectory

Introduction

Ferric carboxymaltose (FCM) has emerged as a leading intravenous iron drug, widely used for treating various forms of anemia, including those related to chronic kidney disease (CKD), cancer, and heart failure. Here, we delve into the market dynamics and financial trajectory of FCM, highlighting its current status, growth prospects, and the factors influencing its market performance.

Market Share and Dominance

FCM has dominated the intravenous iron drugs market, accounting for a significant market share. In 2023, the ferric carboxymaltose segment held a market share of 48%[1][3][4]. This dominance is attributed to its effectiveness, safety, and cost-efficiency, making it a preferred choice for high-dose iron replenishment.

Clinical and Economic Impact

Studies have demonstrated the clinical and economic benefits of FCM. For instance, a cost-offset model analyzing the introduction of FCM for patients with acute heart failure in the UK, Switzerland, and Italy showed significant cost savings. The model projected net cost savings of -£14,008,238, -CHF25,456,455, and -€105,295,146 over a five-year period, primarily due to reduced hospitalizations and avoided cardiovascular deaths[2].

Market Size and Growth Projections

The global intravenous iron drugs market, with FCM as a key segment, is expected to grow substantially. By 2030, the market is projected to reach $4.8 billion, growing at a CAGR of 7.4% from 2022 to 2030. Specifically, the FCM segment is anticipated to record a 7.7% CAGR and reach $2.3 billion by the end of this period[4].

In a more extended forecast, the FCM injection market is valued at $16 billion in 2023 and is expected to reach $30.9 billion by 2031, growing at a CAGR of 9.2% during the forecast period 2024-2031[5].

Regional Market Dynamics

The market for FCM is geographically diverse, with varying growth rates and challenges across different regions.

North America

The North American market, led by the United States and Canada, is characterized by a high prevalence of iron deficiency anemia and robust healthcare infrastructure. This region has stringent regulatory standards, which ensure the safety and efficacy of intravenous iron treatments, driving the growth of the FCM market[5].

Europe

Europe, particularly countries like Germany, France, and the UK, dominates the FCM market due to increasing awareness of anemia management and a growing aging population. The region benefits from supportive healthcare policies and a well-established pharmaceutical regulatory framework[5].

Asia-Pacific

The Asia-Pacific region presents an emerging market with rising incidence of anemia, improved healthcare access, and economic development contributing to the expanding demand for FCM. This region is expected to expand at the fastest CAGR during the forecast period[1][5].

Latin America and Middle East & Africa

Latin America is witnessing gradual growth driven by increasing health awareness and efforts to improve healthcare infrastructure. The Middle East and Africa display contrasting dynamics due to varying levels of healthcare access and economic conditions, affecting the overall market growth[5].

Regulatory Approvals and Product Launches

Regulatory approvals and new product launches are crucial for the expansion of the FCM market. For example, the FDA’s approval of drugs like INJECTAFER for specific conditions has been pivotal in driving market growth. However, the market also faces significant regulatory challenges, including stringent approval processes and varying regulations across different countries, which can delay product launches and increase development costs[1][5].

Impact of COVID-19

The COVID-19 pandemic has influenced the market by increasing the incidence of CKD and acute kidney injury (AKI) among hospitalized COVID-19 patients, thereby boosting the demand for IV iron drugs, including FCM. This increased demand has contributed to the market's growth during the pandemic period[1].

Cost and Competition

Despite its benefits, the FCM market faces cost constraints and intense competition. The high cost of production and competition from cheaper alternatives, such as oral iron supplements and older intravenous formulations, can limit market accessibility and affect profitability. Established brands often dominate the market share, making it challenging for new entrants to gain traction[5].

Patient Awareness and Acceptance

Growing awareness about anemia management is a significant driver for the FCM market. Increasing healthcare spending and supportive healthcare policies enhance patient access to advanced treatments like FCM. However, patient acceptance and awareness vary across regions, influencing the market's growth potential[5].

Financial Implications

The financial implications of FCM treatment are positive, with studies indicating cost savings through reduced hospitalizations and avoided cardiovascular deaths. The cost-offset modeling in the UK, Switzerland, and Italy demonstrated significant net cost savings over a five-year period, highlighting the economic benefits of FCM treatment[2].

Key Takeaways

• Market Dominance: FCM holds a significant market share in the intravenous iron drugs market.
• Clinical and Economic Benefits: FCM treatment is associated with reduced hospitalizations and cost savings.
• Growth Projections: The FCM market is expected to grow substantially, reaching $2.3 billion by 2030 and $30.9 billion by 2031.
• Regional Dynamics: The market is geographically diverse, with North America, Europe, and Asia-Pacific being key regions.
• Regulatory and Cost Challenges: The market faces regulatory hurdles and cost constraints that can impact growth.
• Impact of COVID-19: The pandemic has increased demand for IV iron drugs, including FCM.

FAQs

What is the current market share of ferric carboxymaltose in the intravenous iron drugs market?

Ferric carboxymaltose holds a market share of approximately 48% in the intravenous iron drugs market as of 2023[1][3][4].

How does ferric carboxymaltose impact healthcare costs?

FCM treatment is projected to be a cost-saving intervention, primarily through reduced hospitalizations and avoided cardiovascular deaths, as demonstrated in cost-offset models for the UK, Switzerland, and Italy[2].

What are the key drivers for the growth of the ferric carboxymaltose market?

Key drivers include increasing healthcare spending, growing awareness about anemia management, and supportive healthcare policies. Additionally, the COVID-19 pandemic has boosted demand for IV iron drugs, including FCM[1][5].

Which regions are expected to drive the growth of the ferric carboxymaltose market?

The Asia-Pacific region is expected to expand at the fastest CAGR during the forecast period, while North America and Europe also remain significant markets due to their robust healthcare infrastructure and regulatory frameworks[1][5].

What are the main challenges facing the ferric carboxymaltose market?

The market faces regulatory challenges, cost constraints, and intense competition from other intravenous iron therapies and oral iron supplements. These factors can limit market accessibility and affect profitability[5].

How does regulatory approval impact the ferric carboxymaltose market?

Regulatory approvals, such as those from the FDA, are crucial for market expansion. However, stringent approval processes and varying regulations across countries can delay product launches and increase development costs[1][5].

Sources

1. Biospace: Intravenous Iron Drugs Market Size to Worth Around US$ 7.41 Billion by 2033.
2. PubMed: Clinical and economic impact of ferric carboxymaltose treatment for iron deficiency at discharge in patients hospitalized for acute heart failure.
3. Grand View Research: Intravenous Iron Drugs Market Size And Share Report, 2030.
4. GlobeNewswire: Global Intravenous (IV) Iron Drugs Market to Reach $4.8 Billion by 2030.
5. Verified Market Research: Ferric Carboxymaltose Injection Market Size, Trends & Forecast.