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Last Updated: December 22, 2024

DESFERAL Drug Patent Profile


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

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

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Desferal

A generic version of DESFERAL was approved as deferoxamine mesylate by HOSPIRA on March 17th, 2004.

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Summary for DESFERAL
Drug patent expirations by year for DESFERAL
Drug Prices for DESFERAL

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Recent Clinical Trials for DESFERAL

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

SponsorPhase
Aditya S. Pandey, MDPhase 2
Michigan Medicine PKUHSC Joint Institute for Translational & Clinical ResearchPhase 2
DatametrixPhase 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
Novartis DESFERAL deferoxamine mesylate INJECTABLE;INJECTION 016267-002 May 25, 2000 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis DESFERAL deferoxamine mesylate INJECTABLE;INJECTION 016267-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

DESFERAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DESFERAL (Deferoxamine)

Introduction to DESFERAL (Deferoxamine)

Deferoxamine, marketed under the brand name DESFERAL®, is an injectable medicine primarily used to treat iron overload, a condition that can occur due to frequent blood transfusions, particularly in patients with beta-thalassemia and sickle-cell disease. Here, we delve into the market dynamics and financial trajectory of this crucial medication.

Market Size and Growth Projections

The Deferoxamine market has been experiencing steady growth. As of 2023, the market was valued at USD 382.34 million and is expected to reach USD 401.41 million in 2024. Looking ahead, the market is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.51%, reaching USD 556.84 million by 2030[1].

Market Segmentation

The Iron Chelation Drug Sales Market, which includes Deferoxamine, is segmented based on type, application, and geographical regions. Deferoxamine is one of the key types of iron chelation drugs, alongside Deferiprone and Deferasirox. The primary applications include transfusional iron overload and Non-Transfusion Dependent Thalassemia (NTDT) caused iron overload. Geographically, the market spans North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[3].

Competitive Landscape

The competitive landscape of the Deferoxamine market can be analyzed using Porter's Five Forces framework. This framework helps businesses evaluate their competitive positioning, assess the power dynamics within the market, and determine the profitability of new ventures. Key factors include the bargaining power of suppliers, the bargaining power of buyers, the threat of new entrants, the threat of substitute products, and the intensity of rivalry among existing competitors[1].

External Influences: PESTLE Analysis

External macro-environmental factors significantly impact the Deferoxamine market. A PESTLE analysis (Political, Economic, Social, Technological, Legal, and Environmental) provides insights into these influences. For instance, changes in regulations, economic trends, and consumer preferences can all affect the market. Understanding these factors helps businesses anticipate and prepare for potential risks and opportunities[1].

Recent Developments and Acquisitions

In a significant development, MITEM PHARMA acquired the worldwide rights to DESFERAL® from Novartis in 2024. This acquisition was supported by TechLife Capital, MACSF, and other investment partners. This move reinforces MITEM PHARMA's commitment to securing the availability of Medicines of Major Therapeutic Interest (MITMs) and is expected to further develop and expand the use of Deferoxamine[4].

Financial Implications and Savings

The financial trajectory of Deferoxamine is influenced by various factors, including its inclusion in cost-saving initiatives. For example, the Medicare Part D program has negotiated prices for certain drugs, including those used for iron overload treatment. While Deferoxamine itself is not explicitly mentioned in the first round of negotiated Maximum Fair Prices (MFPs), the overall trend of negotiated prices can impact the market. CMS estimates suggest significant savings for Medicare and beneficiaries through such negotiations, which could indirectly influence the pricing and market dynamics of Deferoxamine[2].

Patient Impact and Savings

Patients, particularly those on Medicare Part D, stand to benefit from cost-saving measures. For instance, CMS estimates that beneficiaries taking selected drugs (including those for iron overload) could save $1.5 billion in out-of-pocket costs under the projected defined standard benefit in 2026. While these estimates are based on specific drugs, they highlight the broader trend of cost reduction in the pharmaceutical market, which can impact Deferoxamine's financial trajectory[2].

Market Drivers and Restraints

The growth of the Deferoxamine market is driven by several factors, including the increasing prevalence of conditions requiring iron chelation therapy, such as beta-thalassemia and sickle-cell disease. Additionally, the inclusion of Deferoxamine in the WHO list of essential medicines underscores its critical role and demand. However, market growth can be restrained by factors such as the availability of alternative treatments, regulatory changes, and economic fluctuations[3].

Geographical Market Dynamics

The market for Deferoxamine varies geographically, with different regions exhibiting different growth rates and demand patterns. For example, the Asia-Pacific region is expected to show significant growth due to a large patient population and increasing healthcare expenditure. Understanding these regional dynamics is crucial for businesses to tailor their strategies and maximize market penetration[3].

Technological and Therapeutic Advancements

Technological advancements and the development of new therapeutic alternatives can impact the Deferoxamine market. For instance, the emergence of oral iron chelators like Deferiprone and Deferasirox may influence the market share of injectable Deferoxamine. However, Deferoxamine's proven efficacy and long-standing use ensure its continued relevance in the treatment of iron overload[3].

Regulatory Environment

The regulatory environment plays a critical role in shaping the market dynamics of Deferoxamine. Changes in regulations, such as those related to drug pricing and reimbursement, can significantly impact the market. For example, the negotiation of Maximum Fair Prices under Medicare Part D can influence the pricing strategy for Deferoxamine and similar drugs[2].

Conclusion

The market for Deferoxamine is characterized by steady growth, driven by increasing demand for iron chelation therapy and supported by its inclusion in the WHO list of essential medicines. The recent acquisition by MITEM PHARMA and the ongoing regulatory and financial trends suggest a positive financial trajectory for this medication.

Key Takeaways

  • Market Growth: The Deferoxamine market is projected to grow at a CAGR of 5.51% from 2023 to 2030.
  • Market Segmentation: The market is segmented by type, application, and geographical regions.
  • Competitive Landscape: Porter's Five Forces and PESTLE analysis are crucial for understanding the competitive and external influences.
  • Recent Developments: MITEM PHARMA's acquisition of worldwide rights to DESFERAL® from Novartis.
  • Financial Implications: Significant savings for Medicare and beneficiaries through negotiated prices.
  • Geographical Dynamics: Varying growth rates and demand patterns across different regions.
  • Technological Advancements: Impact of new therapeutic alternatives on the market.

FAQs

Q1: What is the primary use of Deferoxamine (DESFERAL)? A1: Deferoxamine is primarily used to treat iron overload, which can occur due to frequent blood transfusions, particularly in patients with beta-thalassemia and sickle-cell disease.

Q2: What is the projected market value of Deferoxamine by 2030? A2: The Deferoxamine market is projected to reach USD 556.84 million by 2030, growing at a CAGR of 5.51% from 2023[1].

Q3: Who recently acquired the worldwide rights to DESFERAL? A3: MITEM PHARMA acquired the worldwide rights to DESFERAL from Novartis in 2024, supported by TechLife Capital, MACSF, and other investment partners[4].

Q4: How do regulatory changes impact the Deferoxamine market? A4: Regulatory changes, such as those related to drug pricing and reimbursement, can significantly impact the market. For example, negotiated prices under Medicare Part D can influence the pricing strategy for Deferoxamine[2].

Q5: What are the key drivers of the Deferoxamine market? A5: The growth of the Deferoxamine market is driven by the increasing prevalence of conditions requiring iron chelation therapy, its inclusion in the WHO list of essential medicines, and the lack of effective substitutes in certain therapeutic areas[3].

Sources

  1. 360iResearch, "Deferoxamine Market by Indication, Route Of Administration, Patient ...", 2023.
  2. Avalere, "Manufacturer Learnings from the First Round of Negotiated MFPs", 2024.
  3. Market Research Intellect, "Iron Chelation Drug Sales Market Size, Scope And Forecast Report", 2024.
  4. Business Wire, "MITEM PHARMA Acquires Worldwide Rights to DESFERAL ...", 2024.

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