Deferoxamine mesylate - Generic Drug Details

What are the generic drug sources for deferoxamine mesylate and what is the scope of patent protection?

Deferoxamine mesylate is the generic ingredient in two branded drugs marketed by Dr Reddys, Fresenius Kabi Usa, Gland, Hikma, Hospira, and Mitem Pharma, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for deferoxamine mesylate. Six suppliers are listed for this compound.

Summary for deferoxamine mesylate

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	7
Drug Prices:	Drug price trends for deferoxamine mesylate
What excipients (inactive ingredients) are in deferoxamine mesylate?	deferoxamine mesylate excipients list
DailyMed Link:	deferoxamine mesylate at DailyMed

See drug prices for deferoxamine mesylate

Recent Clinical Trials for deferoxamine mesylate

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

Sponsor	Phase
University of Calgary	PHASE3
The George Institute	PHASE3
Aditya S. Pandey, MD	Phase 2

See all deferoxamine mesylate clinical trials

Pharmacology for deferoxamine mesylate

Drug Class	Iron Chelator
Mechanism of Action	Iron Chelating Activity

Medical Subject Heading (MeSH) Categories for deferoxamine mesylate

Siderophores

Anatomical Therapeutic Chemical (ATC) Classes for deferoxamine mesylate

V03AC	Iron chelating agents
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for deferoxamine mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mitem Pharma	DESFERAL	deferoxamine mesylate	INJECTABLE;INJECTION	016267-002	May 25, 2000		DISCN	Yes	No
Hikma	DEFEROXAMINE MESYLATE	deferoxamine mesylate	INJECTABLE;INJECTION	078086-001	May 30, 2007	AP	RX	No	No
Dr Reddys	DEFEROXAMINE MESYLATE	deferoxamine mesylate	INJECTABLE;INJECTION	076806-002	Mar 31, 2006		DISCN	No	No
Hospira	DEFEROXAMINE MESYLATE	deferoxamine mesylate	INJECTABLE;INJECTION	076019-001	Mar 17, 2004	AP	RX	No	No

Expired US Patents for deferoxamine mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mitem Pharma	DESFERAL	deferoxamine mesylate	INJECTABLE;INJECTION	016267-001	Approved Prior to Jan 1, 1982	3,471,476

Market Dynamics and Financial Trajectory for Deferoxamine Mesylate

Last updated: October 15, 2025

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Introduction

Deferoxamine Mesylate (DFO) is a chelating agent widely used in the treatment of acute iron poisoning and chronic iron overload, particularly in patients receiving long-term blood transfusions such as those with thalassemia, sickle cell anemia, and certain anemias. Its pharmacological efficacy, established safety profile, and considerable market demand have positioned DFO as a critical pharmaceutical agent within the hematology therapeutic landscape. This analysis explores the evolving market dynamics, regulatory considerations, competitive trends, and projected financial trajectory of deferoxamine mesylate from a business innovation and investment perspective.

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Market Overview and Current Landscape

The global iron chelation therapy market, which includes deferoxamine mesylate, is projected to reach approximately USD 4.5 billion by 2026, growing at a compound annual growth rate (CAGR) of about 7%[1]. The increasing prevalence of hereditary iron overload conditions, advancements in drug formulations, and expanding indications contribute significantly to this upward trajectory.

Deferoxamine’s longstanding role as a first-line chelator stems from its established efficacy, especially in acute settings, and its cost-effective profile. Nonetheless, its administration demands parenteral delivery (subcutaneous or intravenous), which limits patient compliance, especially for chronic therapy. This has concurrently driven the development and commercialization of newer, more patient-friendly oral chelators such as deferasirox and deferiprone, which has somewhat curtailed DFO’s market share but also defined a niche within specialized patient demographics.

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Market Dynamics

1. Therapeutic Demand Drivers

The primary demand for deferoxamine mesylate hinges on the increasing burden of iron overload disorders. Notably:

• Hereditary Hemochromatosis and Thalassemia: The global thalassemia population alone is estimated at around 150 million carriers, with significant patient cohorts requiring regular iron chelation therapy[2].
• Blood Transfusion Dependency: Patients receiving repeated transfusions face heightened iron accumulation, creating consistent demand for chelation agents.
• Growing Awareness and Screening: Enhanced diagnostic capabilities and awareness campaigns continue to identify at-risk populations, expanding the market.

2. Pricing and Reimbursement Dynamics

Deferoxamine’s cost-effectiveness maintains its favorable position in markets with robust healthcare reimbursement systems. The injectable form remains less costly compared to newer oral agents. However, reimbursement challenges for chronic, long-term therapy influence prescribing patterns and access, especially in developing regions.

3. Competitive Landscape

While deferasirox and deferiprone introduce oral administration advantages, deferoxamine maintains its relevance where compliance is a concern or in acute emergency settings. Industry players are investing in improved formulations, including slow-release and implantable devices, to enhance adherence, which could impact future market shares.

4. Regulatory and Patent Considerations

Though deferoxamine was originally developed decades ago, certain formulations are under patent protection or regulatory exclusivity in specific markets, impacting generic entry and pricing strategies. The expiration of patents has led to a proliferation of biosimilars and generics, fueling price competition.

5. Innovation and Pipeline Developments

Research into more patient-friendly formulations (e.g., liposomal DFO, implantable devices) is progressing. These innovations aim to address compliance issues and expand indications, particularly in pediatric and chronic patient populations. Success here could reinvigorate market growth and create new revenue streams.

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Financial Trajectory

Historical Revenue Trends

Historically, deferoxamine revenue has been sustained through its extensive use in transfusion-dependent treatments. The product's global sales have maintained stable growth due to consistent clinical demand, with notable regional contributions from Europe and Asia.

Forecasted Growth and Investment Outlook

Forecasts suggest a steady CAGR (~6-8%) over the next five years, heavily influenced by market expansion in emerging economies, demographic trends, and ongoing innovation. However, the growth rate could be moderated by:

• Increased competition from oral agents
• Regulatory hurdles related to new formulations
• Market saturation in developed countries

Impact of Generics and Biosimilars

Patent expiration and regulatory approval of biosimilars are projected to reduce treatment costs, potentially expanding market access but compressing profit margins. Companies pursuing patent extensions or developing novel delivery systems are expected to mitigate this impact.

Potential Revenue Opportunities

• New Formulations: Introduction of slow-release or implantable DFO products may command premium pricing while improving adherence.
• Expanded Indications: Use in conditions such as iron overload due to specific therapies or diseases could further diversify revenue streams.
• Regional Expansion: Growth in emerging markets, where blood transfusion practices are expanding, offers significant revenue prospects.

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Regulatory and Market Challenges

• Safety Concerns: Its association with side effects like infusion site reactions, neurotoxicity, and hypersensitivity demands continued post-marketing surveillance to sustain trust and market acceptance.
• Adherence Barriers: Parenteral administration limits long-term adherence, influencing treatment outcomes and revenues.
• Emerging Competition: The ascendancy of oral chelators has shifted prescribing preferences, necessitating strategic repositioning of DFO within treatment protocols.

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Conclusion and Future Outlook

Deferoxamine mesylate remains a cornerstone in iron overload management, especially in acute and specialized settings. Market dynamics are shaped by demographic trends, technological innovation, and competitive shifts towards oral chelators. Financial forecasts suggest moderate but sustained growth, buoyed by regional expansion and product innovation.

Companies investing in improved delivery systems and expanding indications will likely benefit most from future market opportunities. Regulatory strategies centered on safety, efficacy, and patient adherence will be crucial to maintaining and growing revenues amid intensifying competition.

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Key Takeaways

• The global iron chelation therapy market is poised for continued steady growth, with DFO maintaining a significant role, especially in acute, hospital-based, and specialized niches.
• Market expansion in emerging regions, driven by rising blood transfusion practices and increased disease screening, presents significant opportunity.
• Innovation in formulations—such as slow-release implants—and expanding indications are critical to overcoming compliance barriers and driving revenue.
• The expiration of patents and rise of generics/biosimilars pressure pricing but can potentially broaden access, supporting volume-driven growth.
• Strategic focus on safety, compliance, and novel delivery mechanisms will be vital for sustained profitability.

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FAQs

1. What major factors influence the pricing of deferoxamine mesylate globally?
Pricing is influenced by manufacturing costs, patent status, healthcare reimbursement policies, competitive landscape, and regional regulatory requirements. In markets with strong healthcare systems, reimbursement schemes can lower the out-of-pocket costs for patients, affecting pricing strategies.

2. How does the route of administration impact the market share of deferoxamine?
As a parenteral agent, deferoxamine faces limitations in patient compliance and convenience, particularly for long-term therapy. Oral chelators' advent has shifted some demand away from DFO, though parenteral forms remain vital in acute care or specific patient subgroups.

3. What innovations could revitalizing deferoxamine’s market position?
Development of sustained-release formulations, implantable devices, and combination therapies could improve adherence and expand indications, thereby revitalizing market share.

4. How does regional growth influence the overall financial outlook for deferoxamine?
Emerging markets, with increasing blood transfusion needs and expanding healthcare infrastructure, are prospective high-growth areas, potentially offsetting saturation in mature markets.

5. What regulatory hurdles could impact the commercialization of next-generation DFO formulations?
Approval processes for new delivery systems or formulations require rigorous clinical trials demonstrating safety and efficacy, potentially delaying market entry and impacting revenue projections.

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Sources:

[1] MarketsandMarkets, "Iron Chelation Therapy Market," 2022.
[2] WHO Global Data, "Hemoglobinopathies and Thalassemia," 2021.