You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 15, 2025

DESFERAL Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Desferal, and what generic alternatives are available?

Desferal is a drug marketed by Mitem Pharma and is included in one NDA.

The generic ingredient in DESFERAL is deferoxamine mesylate. There are seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the deferoxamine mesylate profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for DESFERAL?
  • What are the global sales for DESFERAL?
  • What is Average Wholesale Price for DESFERAL?
Summary for DESFERAL
Drug patent expirations by year for DESFERAL
Drug Prices for DESFERAL

See drug prices for DESFERAL

Recent Clinical Trials for DESFERAL

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

SponsorPhase
Michigan Medicine PKUHSC Joint Institute for Translational & Clinical ResearchPhase 2
Aditya S. Pandey, MDPhase 2
Eshmoun Clinical Research CentrePhase 3

See all DESFERAL clinical trials

Pharmacology for DESFERAL
Drug ClassIron Chelator
Mechanism of ActionIron Chelating Activity

US Patents and Regulatory Information for DESFERAL

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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Mitem Pharma DESFERAL deferoxamine mesylate INJECTABLE;INJECTION 016267-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Desferal (Deferoxamine)

Last updated: October 15, 2025

Introduction

Desferal (Deferoxamine) has long been a cornerstone in the treatment of iron overload conditions, primarily in patients undergoing longstanding transfusions for thalassemia, sickle cell disease, and other hematological disorders. As a powerful iron chelating agent, it has established significant clinical utility since its approval, shaping a dynamic market influenced by evolving patient demographics, regulatory pathways, and emerging competitive therapies. This article explores the current market landscape, key drivers, challenges, and financial outlook for Desferal over the coming years.

Historical and Clinical Context

Deferoxamine, marketed as Desferal by Novartis, received FDA approval in the 1960s, pioneering iron chelation therapy. Its efficacy in reducing iron burden from transfusions has cemented its position for decades, especially in pediatric populations. However, traditional administration via subcutaneous infusion posed compliance challenges, prompting a shift toward newer formulations and alternative chelators such as deferasirox and deferiprone, which offer oral administration and improved patient adherence.

Despite these advancements, Desferal remains indispensable in certain clinical scenarios, notably in acute iron poisoning and cases where oral chelators are contraindicated or insufficient. Its continued clinical relevance sustains a stable, albeit somewhat matured, market presence.

Market Dynamics

Key Drivers

1. Demographic Trends and Disease Prevalence

The global thalassemia and sickle cell disorder burdens drive demand for iron chelation therapies. An estimated 60,000–70,000 individuals are born annually with severe hemoglobinopathies, with higher prevalence rates in Mediterranean, Middle Eastern, African, and Southeast Asian populations. As life expectancy improves owing to enhanced transfusion management, the cohort requiring long-term iron chelation — including Desferal — increases correspondingly.

2. Advancements in Chelation Therapy

The shift toward oral chelators like deferasirox (Exjade, Jadenu) and deferiprone (Ferriprox) challenges Desferal’s market share. These agents provide greater convenience, leading to improved compliance and patient preference, especially in regions with limited healthcare infrastructure for infusion therapy. Nonetheless, Desferal persists in specific contexts such as severe iron overload or intolerance to oral agents.

3. Regulatory and Patent Landscape

Decferoxamine's patent status has expired in most jurisdictions, encouraging generic production. The entry of generics has driven prices downward and expanded availability in emerging markets. Regulatory approvals for new delivery systems or formulations, such as inhalable or implant-based Desferal, could influence future market dynamics positively or negatively, depending on clinical success and adoption rates.

4. Healthcare Infrastructure and Access

Regions with advanced healthcare systems and infrastructure for infusion therapy sustain steady demand. Conversely, low-resource settings face barriers in administering Desferal, favoring oral, more user-friendly chelators. Strategic partnerships, donation programs, and government policies influence Desferal’s market penetration in these areas.

Challenges and Limitations

1. Administration Burden

Desferal's requirement for prolonged subcutaneous infusion, typically over 8–12 hours daily via infusion pumps, hampers adherence, especially in pediatric and adolescent patients. This significantly limits its appeal relative to oral options, creating a threat to its market share.

2. Competition from Oral Chelators

The advent of deferasirox and deferiprone, with their oral dosing regimens, has reoriented treatment paradigms. The global deferasirox market alone was valued at over USD 500 million in recent years and is expected to grow at a CAGR of approximately 6% through 2030 [1]. These alternatives are outperforming Desferal in patient acceptance, especially in developed markets.

3. Generic Competition and Pricing Pressure

Patent expiration and losses of exclusivity have facilitated proliferation of affordable generics, exerting downward pressure on pricing and overall revenues related to Desferal under the brand or generic names.

Emerging Market Opportunities

Hybrid formulations of Desferal (e.g., inhalable or depot forms), if developed successfully, could re-establish its competitive edge by reducing infusion-related challenges. Moreover, as gene therapies for hemoglobinopathies progress towards commercialization, the consequent reduction in transfusion requirements could eventually diminish the demand for iron chelators, including Desferal.

Financial Trajectory and Market Forecast

Current Market Valuation

While precise global sales figures for Desferal are not publicly disclosed, industry estimates suggest a relatively modest market share compared to oral chelators. The global iron chelation therapy market was valued at approximately USD 1.2 billion in 2020 and is projected to reach nearly USD 2 billion by 2028, with Desferal contributing a declining but vital segment within this space [1].

Revenue Forecast and Growth Outlook

Analyst projections indicate a slow decline in Desferal’s revenues, primarily attributable to:

  • Increasing adoption of oral chelators
  • Market saturation in mature regions
  • Replacement in standard-of-care protocols for new cases

Nevertheless, in regions with limited healthcare access or specific clinical indications, Desferal will maintain a durable demand, ensuring a steady revenue stream. The expected compound annual growth rate (CAGR) for Desferal-specific revenues could hover around -2% to -3% over the next decade, considering the shift toward oral formulations and generic proliferation.

Potential for Innovation and Market Entry

Future growth hinges on innovation—particularly, developing novel delivery systems that mitigate administration challenges. Successful commercialization of inhalable or implantable Desferal variants could catalyze a rebound in demand, especially if they demonstrate superior efficacy and patient compliance. Furthermore, expanding indications to emergency iron poisoning or adjunctive uses could add revenue streams.

Strategic Considerations for Stakeholders

Pharmaceutical Companies:
Investing in formulation innovations and expanding into emerging markets is vital. Managing pricing strategies amid generic competition requires balancing affordability and profitability.

Healthcare Providers:
Prioritizing patient-centered approaches and adherence strategies can optimize Desferal’s clinical utility where its use remains advantageous.

Regulatory Bodies:
Facilitating approval processes for new delivery systems and ensuring equitable access can influence market dynamics positively.

Investors:
Monitoring pipeline developments, patent statuses, and regional market trends provides insights into future revenue prospects for Desferal.

Conclusion

Desferal (Deferoxamine) remains a clinically significant, though aging, player in iron chelation therapy. Its market dynamics are increasingly influenced by technological innovation, patient preferences for oral regimens, and global healthcare infrastructure disparities. While its revenue trajectory may trend downward in developed markets, strategic innovation and expanding indications could sustain its relevance. Recognizing the shifting landscape is essential for stakeholders aiming to optimize clinical outcomes and financial performance.


Key Takeaways

  • Desferal’s demand is sustained in specific clinical scenarios and regions with limited access to oral chelators.
  • The evolution toward oral agents like deferasirox and deferiprone has resulted in declining revenues for Desferal, compounded by generic price competition.
  • Innovation in delivery systems could revitalize Desferal’s market position, especially in niche applications.
  • Market growth will be uneven, with mature markets decling and emerging markets offering growth opportunities due to expanding hematological disorder burdens.
  • Investors and manufacturers should closely monitor regulatory developments, pipeline innovations, and regional healthcare trends to inform strategic decisions.

FAQs

Q1: What factors are most influencing Desferal’s market decline?
A1: The primary factors include the availability of oral chelators offering easier administration, generic competition reducing prices, and clinical preferences shifting towards more patient-friendly therapies.

Q2: Are there ongoing innovations to improve Desferal’s administration?
A2: Yes, research is underway to develop inhalable formulations, depot injections, and implantable systems aimed at simplifying administration and improving adherence.

Q3: How significant is Desferal’s role in developing markets?
A3: In emerging regions with limited healthcare infrastructure, Desferal remains vital due to its efficacy and lower costs associated with generic versions, sustaining its market share.

Q4: Could gene therapies impact the future demand for Desferal?
A4: Potentially. As hemoglobinopathy treatments evolve with gene editing techniques, the need for transfusion and consequently for iron chelators like Desferal may diminish, affecting long-term demand.

Q5: What strategic measures should companies consider to sustain Desferal revenues?
A5: Focus on developing improved formulations, expanding indications, forming partnerships for distribution, and targeting underserved markets can help maintain relevance and revenue streams.


References

[1] MarketWatch. “Iron Chelation Therapy Market Size, Share & Industry Analysis,” 2021.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.