DEXFERRUM Drug Patent Profile

Which patents cover Dexferrum, and when can generic versions of Dexferrum launch?

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

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

International Patents for DEXFERRUM

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

Country	Patent Number	Title	Estimated Expiration
Japan	3471363
Canada	2184551	FORMULATIONS A BASE DE DEXTRANE DE FER (IRON DEXTRAN FORMULATIONS)
Portugal	855913
Denmark	0855913

Investment Scenario and Fundamentals Analysis for Dexferrum (Iron Dextran)

Last updated: February 20, 2026

What is Dexferrum and its Market Position?

Dexferrum is a brand of iron dextran, an intravenous iron formulation used to treat iron deficiency anemia. It is approved by the U.S. Food and Drug Administration (FDA), with the brand marketed primarily by American Regent. The drug has maintained a steady presence in hospitals and clinics for decades due to its effectiveness and low-cost profile.

The global iron deficiency anemia (IDA) treatment market was valued at approximately USD 5.2 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 6.3% through 2030, driven by increasing cases of anemia, chronic kidney disease, and surgical procedures requiring iron supplementation.

Dexferrum holds a significant share within the intravenous iron segment, competing with newer agents like ferumoxytol (Feraheme), ferric carboxymaltose (Fefolta), and iron sucrose (Venofer). Its market position benefits from an established manufacturing process, a broad physician familiarity, and a relatively low price point.

What Are the Key Investment Fundamentals for Dexferrum?

1. Regulatory Status and Approvals

Dexferrum is approved by the FDA under a Biologics License Application (BLA). Its approval extends to multiple countries, making it a globally available option. Patent expirations occurred years ago, leaving the formulation open for generic manufacturing, increasing price competition.

2. Manufacturing and Supply Chain

Dexferrum’s manufacturing is performed domestically in the United States. It benefits from an established supply chain infrastructure. However, dependency on a limited number of manufacturing facilities exposes it to operational risks.

3. Market Dynamics and Competitive Landscape

The intravenous iron market is increasingly competitive, with newer agents offering advantages such as lower infusion reactions and faster dosing. Despite this, Dexferrum advantages include:

• Proven long-term safety profile.
• Cost advantage, often priced lower than newer alternatives.
• Broad clinician familiarity.

4. Pricing and Reimbursement Environment

Price pressures stem from the availability of generic alternatives. Reimbursement policies are favorable in many U.S. healthcare settings, with insurance coverage for hospital-administered iron therapies generally stable. Price erosion may impact margins, especially as competing drugs gain market share.

5. Clinical Efficacy and Safety Profile

Dexferrum displays efficacy comparable to other intravenous iron therapies via high-dose administration. Safety concerns related to anaphylaxis are well-managed through infusion protocols. The safety profile remains acceptable, but competition's newer formulations are marketed as having fewer adverse reactions.

6. R&D and Pipeline Potential

Dexferrum has limited scope for R&D, given its mature status. Future growth may depend on expanding indications such as chronic kidney disease (CKD) or inflammatory bowel disease (IBD), or through approval to expand formulations and dosing regimens.

7. Patent and Intellectual Property

Patent protections have expired, increasing exposure to generic competition. This trend pressures pricing and market share. No active patents limit manufacturing or distribution currently.

Financial Analysis and Investment Outlook

Aspect	Detail
Revenue Trends	Stable in hospital settings; declining in outpatient due to new competitors
Market Share	Estimated at 15-20% within IV iron segment in the U.S., with potential decline due to generics
Pricing Pressure	Significant over the last five years, continuing with generics and biosimilars
Cost Structure	Low production costs, high margin potential in hospital procurement
Growth Drivers	Expanding use in anemia associated with CKD, surgical bleeding, and IBD
Risks	Market share erosion, regulatory non-compliance, manufacturing disruptions

Investment Considerations

• Stable demand in hospital-based treatment; however, long-term decline likely due to generics.
• Low-cost entry point for generic manufacturers; potential for price erosion.
• Limited pipeline restricts growth prospects.
• A shift toward newer agents with better safety profiles could diminish market share.
• The drug may benefit from healthcare policies favoring hospital-based, cost-effective treatments.

Key Takeaways

• Dexferrum remains a backbone in intravenous iron therapy with established standards but faces declining margins due to generic competition.
• Its market sustainability depends on expanding indications and maintaining cost advantages.
• Competitive pressures are likely to intensify with the entry of biosimilars and new formulations.
• Future growth hinges on the healthcare landscape's acceptance of cost-effective, hospital-administered iron therapies.
• Risk of obsolescence exists if newer agents gain preferential reimbursement or broader acceptance.

FAQs

1. What challenges does Dexferrum face from newer iron therapies?
Newer agents like ferric carboxymaltose and ferumoxytol have faster infusion times and lower adverse reaction rates, making them more attractive, especially for outpatient use.

2. How does the pricing of Dexferrum compare with its competitors?
Dexferrum is generally priced lower than newer agents, which can provide a competitive advantage in hospital procurement but faces pressure from generics reducing prices over time.

3. What is the outlook for Dexferrum in emerging markets?
Emerging markets with cost-sensitive healthcare systems may continue to favor Dexferrum due to its established safety profile and affordability.

4. Are there regulatory risks for Dexferrum?
While currently approved, any new safety signals or changes in regulatory standards could impact ongoing approval or reimbursement.

5. Could R&D revive Dexferrum's market position?
Limited R&D exists; innovations would require new formulations or indications, which are unlikely to significantly alter the mature market landscape.

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Citations

1. Grand View Research. (2023). Intravenous Iron Drugs Market Size & Trends.
2. U.S. Food and Drug Administration. FDA-approved drugs database (2023).
3. MarketWatch. (2022). Iron Deficiency Anemia Treatment Market Forecast.
4. EvaluatePharma. (2023). 2023 Global Drug Sales and Market Share Data.
5. American Hospital Association. (2022). Hospital procurement policies and drug utilization.