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 iron dextran. There are eighty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iron dextran 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
Luitpold Pharmaceuticals	Phase 4
American Regent, Inc.	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	iron dextran	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	iron dextran	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
Australia	702691
Australia	6964796
Denmark	0855913
Japan	3471363
Canada	2184551	FORMULATIONS A BASE DE DEXTRANE DE FER (IRON DEXTRAN FORMULATIONS)
Portugal	855913

Market Dynamics and Financial Trajectory for Dexferrum

Last updated: April 5, 2026

What is Dexferrum?

Dexferrum is an iron dextran injection used to treat iron deficiency anemia, especially in patients unable to tolerate oral iron therapy. Marketed by Pharmacosmos A/S, it operates primarily within hospital and specialty care settings, including regions with active healthcare infrastructure for intravenous iron therapies.

Market Size and Growth Drivers

Global Market Overview

The intravenous iron market, which includes Dexferrum, is valued at approximately USD 1.4 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 7.2% from 2023 to 2030. Growth stems from increasing prevalence of anemia globally, particularly in chronic kidney disease (CKD) and cancer populations.

Key Regions

Region	Market Share (2022)	Growth Drivers
North America	45%	High CKD prevalence, advanced healthcare infrastructure
Europe	26%	Aging population, rising anemia awareness
Asia-Pacific	20%	Large population base, expanding healthcare access
Rest of World	9%	Increasing diagnosis rates, evolving healthcare systems

Drivers Increasing Market Penetration

• Surge in CKD cases requiring erythropoietin-stimulating agents often paired with IV iron.
• Rising anemia prevalence in pregnant women and elderly.
• Preference for intravenous over oral iron in malabsorption or intolerance cases.
• Improving healthcare infrastructure, especially in emerging markets.

Competitive Landscape

Major Players

Company	Product Portfolio	Market Share (Estimated, 2022)	Key Features
Pharmacosmos A/S	Dexferrum, Monofer	35%	Focus on intravenous iron, strong regional presence
American Regent (Part of ACL)	INFeD, Ferrlecit	25%	Established in US, extensive hematology portfolio
Vifor Pharma	Ferinject (Injectafer), Venofer	20%	Wide global distribution, FDA and EMA approvals
Others	Various regional brands	20%	Niche and emerging markets

Market Entry Barriers

• Stringent regulatory requirements (FDA, EMA).
• Safety concerns about allergic reactions and anaphylaxis.
• High manufacturing costs for complex intravenous formulations.
• Established presence of leading brands creating a high barrier for new entrants.

Regulatory and Pricing Factors

Regulatory Status

Dexferrum is approved in North America and Europe. It faces evolving regulations concerning safety, with updates on labeling for hypersensitivity reactions. Emerging markets exhibit varying approval statuses, influencing market access.

Pricing Trends

Average wholesale prices (AWP):

Region	Price per 100 mg vial (USD)	Comments
North America	45-60	Reflects regulatory and market competition
Europe	40-55	Varies with reimbursement policies
Asia-Pacific	20-35	Lower due to competitive pricing and regulatory differences

Reimbursement policies impact patient access. Hospitals often negotiate discounts, affecting profit margins.

Revenue Trajectory

Historical Revenue (2020–2022)

Year	Estimated Revenue (USD millions)
2020	85
2021	100
2022	115

Projected Revenue (2023–2030)

Assuming a CAGR of 7.2%:

Year	Projected Revenue (USD millions)
2023	123
2025	147
2030	198

Growth driven by increased demand in CKD and cancer-related anemia, expanding approvals, and geographic expansion into emerging markets.

R&D and Innovation Outlook

Limited new formulations of Dexferrum pending, but the focus is on improving safety profiles and administration protocols. Development of alternative routes (e.g., oral iron formulations with higher bioavailability) could impact market dynamics but currently lag behind intravenous options in efficacy for certain populations.

Risks and Challenges

• Safety concerns such as hypersensitivity reactions.
• Competition from newer, less immunogenic formulations.
• Regulatory risks influencing market access and pricing.
• Supply chain disruptions affecting manufacturing and distribution.

Key Takeaways

• The intravenous iron market, including Dexferrum, grows steadily driven by increasing anemia prevalence.
• Market leaders hold significant regional shares, maintaining dominance through established safety profiles and regulatory approval.
• Growth is projected to continue, with revenue reaching approximately USD 198 million by 2030.
• Regulatory and safety concerns remain critical barriers in market expansion.
• Emerging markets and improving healthcare infrastructure will be key areas for future growth.

FAQs

1. What are the primary therapeutic advantages of Dexferrum?
Dexferrum offers rapid repletion of iron stores for patients with iron deficiency anemia, especially those intolerant to oral iron or with malabsorption issues.

2. How does Dexferrum compare to other intravenous iron products?
It has a well-established safety profile but faces competition from newer formulations with lower immunogenicity and fewer hypersensitivity reactions.

3. What factors influence the pricing of Dexferrum globally?
Reimbursement policies, regulatory approval status, manufacturer pricing strategies, and local market competition.

4. Are there notable regulations affecting Dexferrum's marketability?
Yes. Regulatory agencies mandate safety warnings concerning hypersensitivity risks and require ongoing pharmacovigilance.

5. What are the prospects for Dexferrum’s market growth in emerging economies?
Growth prospects are favorable, provided regulatory requirements are met, and distribution channels are established, especially as anemia management becomes prioritized.

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References

1. MarketsandMarkets. (2022). Intravenous Iron Market by Form, Application, and Region. Retrieved from https://www.marketsandmarkets.com
2. Pharmacosmos A/S. (2023). Dexferrum product dossier.
3. Vifor Pharma. (2022). Market Overview for Intravenous Iron.
4. GlobalData. (2023). Hematology Drug Market Reports.
5. World Health Organization. (2022). Global Prevalence of Anemia.