DEXFERRUM Drug Patent Profile

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

Dexferrum is a drug marketed by Am Regent and is included in one NDA.

The generic ingredient in DEXFERRUM is ferric oxyhydroxide. There are twenty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ferric oxyhydroxide profile page.

Summary for DEXFERRUM

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	33
Clinical Trials:	1
DailyMed Link:	DEXFERRUM at DailyMed

Recent Clinical Trials for DEXFERRUM

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

Sponsor	Phase
American Regent, Inc.	Phase 4
Luitpold Pharmaceuticals	Phase 4

See all DEXFERRUM clinical trials

US Patents and Regulatory Information for DEXFERRUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Am Regent	DEXFERRUM	ferric oxyhydroxide	INJECTABLE;INJECTION	040024-001	Feb 23, 1996		DISCN	No	No

Expired US Patents for DEXFERRUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Am Regent	DEXFERRUM	ferric oxyhydroxide	INJECTABLE;INJECTION	040024-001	Feb 23, 1996	5,624,668

International Patents for DEXFERRUM

See the table below for patents covering DEXFERRUM around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2184551	FORMULATIONS A BASE DE DEXTRANE DE FER (IRON DEXTRAN FORMULATIONS)
Australia	702691
Spain	2179207
European Patent Office	0855913	FORMULATIONS FER-DEXTRAN (IRON DEXTRAN FORMULATIONS)
Portugal	855913

DEXFERRUM Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Dexferrum

Introduction to Dexferrum

Dexferrum, an intravenous iron dextran formulation, is used to treat iron deficiency anemia in patients where oral iron administration is unsatisfactory or impossible. Here, we delve into the market dynamics and financial trajectory of Dexferrum, a key player in the intravenous iron drugs market.

Global Intravenous Iron Drugs Market Overview

The global intravenous iron drugs market is experiencing significant growth, driven by increasing incidences of chronic kidney diseases, anemia, and other conditions. The market was valued at USD 2.22 billion in 2020 and is expected to grow at a CAGR of 8.6% from 2021 to 2028[3].

Market Size and Growth Projections

As of 2023, the global intravenous iron drugs market was evaluated at USD 3.24 billion and is projected to reach around USD 7.41 billion by 2033, growing at a substantial CAGR[1].

Regional Market Stance

North America currently holds the largest market share in the intravenous iron drugs market, driven by rising approvals from healthcare authorities and the introduction of new formulations. However, the Asia Pacific region is expected to expand at the fastest CAGR during the forecast period due to growing unmet patient needs and increasing healthcare expenditure[1][4].

Product Segments and Competitive Landscape

The ferric carboxymaltose (FCM) segment dominates the market in terms of revenue generation, largely due to its better performance, cost-effectiveness, and minimal risk of anaphylactic reactions. However, the iron dextran segment, which includes Dexferrum, still holds a significant market share, although its growth is slower due to adverse events associated with high-molecular-weight iron dextran formulations[3][4].

Challenges and Risks Associated with Dexferrum

Dexferrum, a high-molecular-weight iron dextran, is associated with several adverse events, including anaphylactic-type reactions, which can be fatal. These risks have led to a preference for lower-molecular-weight iron dextran formulations like Cosmofer and INFeD, which are safer and less prone to adverse events[2][4].

Regulatory and Safety Considerations

The use of Dexferrum is regulated by strict guidelines due to its potential for severe adverse reactions. It is contraindicated in patients with hypersensitivity to the product and should be used with extreme caution in patients with serious impairment of liver function or underlying cardiovascular disease. A test dose is mandatory before the first therapeutic dose to monitor for anaphylactic-type reactions[2].

Market Impact of Adverse Events

The high incidence of adverse events associated with Dexferrum has impacted its market growth. While it remains a viable option for treating iron deficiency anemia, the availability of safer alternatives has reduced its market share. The iron dextran segment, which includes Dexferrum, is expected to grow at a slower rate compared to other segments like ferric carboxymaltose[4].

Financial Trajectory

Despite the challenges, Dexferrum continues to contribute to the overall revenue of the intravenous iron drugs market. However, its financial trajectory is influenced by the preference for safer and more effective alternatives. The market share of Dexferrum is expected to decline as newer, safer formulations gain more acceptance and approval from healthcare authorities[1][3][4].

Applications and Revenue Share

Dexferrum is primarily used in the treatment of chronic kidney disease, inflammatory bowel disease, and other conditions associated with iron deficiency anemia. The chronic kidney disease segment accounts for a significant revenue share, approximately 35% in 2023, which indirectly supports the market presence of Dexferrum[1].

Future Outlook

The future outlook for Dexferrum is cautious, given the rising competition from safer and more effective intravenous iron formulations. While it will continue to be used in certain clinical scenarios, its market share and financial contribution are likely to diminish as the market shifts towards newer, less risky alternatives.

Key Takeaways

• The global intravenous iron drugs market is growing, driven by increasing incidences of chronic kidney diseases and anemia.
• Dexferrum, a high-molecular-weight iron dextran, faces challenges due to associated adverse events.
• The market is shifting towards safer alternatives like ferric carboxymaltose.
• North America is the largest market, but the Asia Pacific region is expected to grow the fastest.
• Regulatory and safety considerations are critical for the use of Dexferrum.

FAQs

Q: What is the current market size of the intravenous iron drugs market? A: The global intravenous iron drugs market was valued at USD 3.24 billion in 2023[1].

Q: What are the primary risks associated with Dexferrum? A: The primary risks include anaphylactic-type reactions, which can be fatal, and other adverse events such as cardiovascular complications in patients with pre-existing conditions[2].

Q: Which region is expected to grow the fastest in the intravenous iron drugs market? A: The Asia Pacific region is expected to expand at the fastest CAGR during the forecast period[1].

Q: What is the dominant segment in the intravenous iron drugs market? A: The ferric carboxymaltose (FCM) segment dominates the market in terms of revenue generation[3].

Q: Why is the market share of Dexferrum declining? A: The market share of Dexferrum is declining due to the availability of safer and more effective alternatives like ferric carboxymaltose and lower-molecular-weight iron dextran formulations[4].

Cited Sources

1. Biospace: Intravenous Iron Drugs Market Size to Worth Around US$ 7.41 Billion by 2033
2. FDA: Dexferrum Label
3. Polaris Market Research: Intravenous Iron Drugs Market Size, Share, Trends & Forecast 2028
4. Straits Research: Intravenous Iron Drugs Market Size, Share And Growth Report, 2031