FERIDEX I.V. Drug Patent Profile

Which patents cover Feridex I.v., and what generic alternatives are available?

Feridex I.v. is a drug marketed by Amag Pharms Inc and is included in one NDA.

The generic ingredient in FERIDEX I.V. is ferumoxides. Additional details are available on the ferumoxides profile page.

Summary for FERIDEX I.V.

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	8
Patent Applications:	1,517
DailyMed Link:	FERIDEX I.V. at DailyMed

US Patents and Regulatory Information for FERIDEX I.V.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amag Pharms Inc	FERIDEX I.V.	ferumoxides	INJECTABLE;INJECTION	020416-001	Aug 30, 1996		DISCN	No	No

Expired US Patents for FERIDEX I.V.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amag Pharms Inc	FERIDEX I.V.	ferumoxides	INJECTABLE;INJECTION	020416-001	Aug 30, 1996	5,248,492
Amag Pharms Inc	FERIDEX I.V.	ferumoxides	INJECTABLE;INJECTION	020416-001	Aug 30, 1996	4,770,183
Amag Pharms Inc	FERIDEX I.V.	ferumoxides	INJECTABLE;INJECTION	020416-001	Aug 30, 1996	5,219,554
Amag Pharms Inc	FERIDEX I.V.	ferumoxides	INJECTABLE;INJECTION	020416-001	Aug 30, 1996	5,102,652
Amag Pharms Inc	FERIDEX I.V.	ferumoxides	INJECTABLE;INJECTION	020416-001	Aug 30, 1996	5,055,288

International Patents for FERIDEX I.V.

See the table below for patents covering FERIDEX I.V. around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	151991
Germany	563249
World Intellectual Property Organization (WIPO)	9305088
Canada	2105068
European Patent Office	0275285	MATERIAU SUPER PARAMAGNETIQUE BIODEGRADABLE UTILISE DANS DES APPLICATIONS CLINIQUES (BIODEGRADABLE SUPERPARAMAGNETIC MATERIALS USED IN CLINICAL APPLICATIONS)

FERIDEX I.V. Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Intravenous Iron Drugs: Focus on Ferric Carboxymaltose and Other Formulations

Introduction

The global intravenous (IV) iron drugs market is experiencing significant growth, driven by several key factors including the rising prevalence of chronic diseases, advancements in IV iron formulations, and regulatory approvals. Here, we will delve into the market dynamics and financial trajectory of IV iron drugs, with a particular focus on formulations like ferric carboxymaltose.

Global Market Size and Growth

The global IV iron drugs market was valued at approximately $3.24 billion in 2023 and is projected to reach around $7.41 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 8.62% from 2024 to 2033[1][4].

Key Drivers of Market Growth

Rising Prevalence of Chronic Diseases

Chronic kidney disease (CKD), cancer, and inflammatory bowel disease (IBD) are major drivers for the demand for IV iron drugs. CKD, in particular, is a significant segment due to the high prevalence of iron deficiency anemia (IDA) among CKD patients[1][4].

Advancements in IV Iron Formulations

Ferric carboxymaltose (FCM) has emerged as a leading IV iron drug due to its effectiveness, safety, and cost-efficiency. FCM is preferred for its high-dose iron replenishment capabilities and is used for treating various forms of anemia, including those related to cancer and CKD. Newer formulations, such as nanoparticle-based formulations, are also enhancing iron absorption and minimizing side effects[1][4].

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[1].

Regulatory Approvals and Product Launches

New product launches and approvals are critical for market expansion. For example, the FDA’s approval of drugs like INJECTAFER (ferric carboxymaltose injection) for specific conditions has been pivotal in driving market growth. INJECTAFER was approved in June 2023 for treating iron deficiency in adults with heart failure classified as New York Heart Association classes II/III[4].

Market Segmentation

By Product

The market is segmented into iron sucrose, iron dextran, and ferric carboxymaltose. Ferric carboxymaltose dominated the market with a revenue share of 48% in 2023 due to its superior performance and fewer adverse effects[1][4].

By Application

The primary applications include chronic kidney disease, inflammatory bowel disease, cancer, and other diseases. CKD accounted for a revenue share of 35% in 2023, highlighting its significant impact on the market[1].

By Geography

North America currently dominates the IV iron drugs market, holding the largest share. The region's dominance is attributed to the increasing approvals and launch of new IV drugs in the U.S. and Canada. Europe holds the second largest market share, while the Asia Pacific region is expected to expand at the fastest CAGR during the forecast period[1][4].

Regional Stance

North America

North America accounted for 52% of the market share in 2023. In the U.S., up to 40% of females aged 12 to 21 may experience iron deficiency, underscoring the significant demand for effective treatments. Ferinject (ferric carboxymaltose) is a prominent IV iron therapy with marketing authorization in 87 countries as of March 2024[1].

Europe

The European market is driven by the presence of major market players, the development and commercialization of new drugs, and the rising incidence of cancer. Germany dominates the regional market due to high healthcare expenditures, easy availability of drugs, and increasing government support[4].

Asia Pacific

The Asia Pacific region is anticipated to witness the fastest growth, driven by the increasing prevalence of chronic diseases such as CKD, IBD, and cancer. China and Japan are key markets, with China focusing on improving healthcare R&D and Japan experiencing a growing geriatric population[4].

Key Players

The market is competitive, with key players including Allergan Plc, AMAG Pharmaceuticals, Inc., Daiichi Sankyo, Inc., Luitpold Pharmaceuticals, Inc., American Regent, Inc., Pharmacosmos A/S, Sanofi US, and Vifor Pharma Ltd.[1].

Financial Trajectory

Revenue Growth

The global IV iron drugs market is expected to grow significantly, with a projected CAGR of 8.62% from 2024 to 2033. This growth is driven by increasing demand, technological advancements, and regulatory approvals[1].

Market Size Projections

By 2033, the market is expected to reach around $7.41 billion. The Asia Pacific region is anticipated to expand at the fastest CAGR during this period, driven by the rising prevalence of chronic diseases[1].

Safety and Efficacy Concerns

While IV iron drugs have demonstrated safety in numerous studies, concerns remain about hypersensitivity reactions. Newer formulations, such as dextran-free and test dose-free options, are being developed to address these concerns and improve safety profiles[1].

Technological Advancements

Advancements in drug delivery systems, such as nanoparticle-based formulations, are enhancing iron absorption and minimizing side effects. Innovative infusion systems and biocompatible materials are also improving the precision and reliability of IV iron therapy administration[4].

Regulatory Environment

Regulatory approvals play a crucial role in the market's growth. For instance, the FDA’s approval of INJECTAFER for treating iron deficiency in adults with heart failure has been a significant milestone. Similar approvals in other regions, such as China and Canada, further support market expansion[1][4].

Key Takeaways

• The global IV iron drugs market is projected to grow significantly, driven by the rising prevalence of chronic diseases and advancements in IV iron formulations.
• Ferric carboxymaltose dominates the market due to its effectiveness, safety, and cost-efficiency.
• North America currently holds the largest market share, but the Asia Pacific region is expected to grow at the fastest CAGR.
• Regulatory approvals and new product launches are critical for market growth.
• Technological advancements in drug delivery systems are improving treatment outcomes.

FAQs

What is the current market size of the global intravenous iron drugs market?

The global intravenous iron drugs market was valued at approximately $3.24 billion in 2023[1].

What is the projected growth rate of the global intravenous iron drugs market?

The market is expected to grow at a CAGR of 8.62% from 2024 to 2033[1].

Which region dominates the intravenous iron drugs market?

North America currently dominates the market, holding the largest share[1].

What are the key drivers of the intravenous iron drugs market?

Key drivers include the rising prevalence of chronic diseases, advancements in IV iron formulations, and regulatory approvals[1][4].

Which IV iron drug formulation is most prominent in the market?

Ferric carboxymaltose (FCM) is the most prominent formulation due to its effectiveness, safety, and cost-efficiency[1][4].

Sources

1. Biospace: Intravenous Iron Drugs Market Size to Worth Around US$ 7.41 Billion by 2033.
2. MDPI: Ultrashort Echo Time Quantitative Susceptibility Mapping (UTE-QSM).
3. IQVIA: Drug Expenditure Dynamics 1995-2020.
4. Grand View Research: Intravenous Iron Drugs Market Size And Share Report, 2030.
5. Frontiers in Immunology: Neutrophil Inflammatory Response Is Downregulated by Uptake of Iron Oxide Nanoparticles.