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
The George Institute	PHASE3
University of Calgary	PHASE3
Michigan Medicine PKUHSC Joint Institute for Translational & Clinical Research	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
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	076019-002	Mar 17, 2004	AP	RX	No	Yes
Hospira	DEFEROXAMINE MESYLATE	deferoxamine mesylate	INJECTABLE;INJECTION	076019-001	Mar 17, 2004	AP	RX	No	No
Fresenius Kabi Usa	DEFEROXAMINE MESYLATE	deferoxamine mesylate	INJECTABLE;INJECTION	078718-001	Sep 15, 2009	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

Market Dynamics and Financial Trajectory for Deferoxamine Mesylate

Last updated: March 17, 2026

What is the current market landscape for Deferoxamine Mesylate?

Deferoxamine Mesylate (DFO) is an iron-chelating agent used primarily for acute and chronic iron overload management. The drug's market extends across hospitals, clinics, and specialty care centers treating conditions such as thalassemia, sickle cell anemia, and other transfusion-related iron overload.

The global DFO market was valued at approximately USD 200 million in 2022. It is expected to grow at a compound annual growth rate (CAGR) of 4.3% from 2023 to 2030, reaching roughly USD 290 million by 2030 (ResearchandMarkets, 2023).

How do market drivers influence the growth trajectory?

Increasing prevalence of transfusion-dependent anemias

The rise in cases of thalassemia, sickle cell anemia, and other disorders requiring frequent transfusions amplifies iron overload treatments. An estimated 300,000 children globally are born annually with thalassemia major, predominantly in Middle East, South Asia, and Southern Europe (WHO, 2022).

Growing awareness and diagnosis

Enhanced diagnostic capabilities and health infrastructure expansion increase detection rates of iron overload. This trend boosts demand for chelators like DFO.

Limited alternative therapies

Deferoxamine’s status as an established, approved treatment for iron overload maintains its market dominance. While oral chelators such as deferasirox and deferiprone exist, DFO remains preferred in acute settings and for certain patient populations.

Patent and regulatory landscape

Deferoxamine itself is off-patent, exposing the market to generic competition. No new formulations or methods are currently under major patent protection, limiting revenue growth potential.

What challenges impact market growth?

Administration mode

Deferoxamine requires parenteral infusion via subcutaneous or intravenous routes, affecting patient compliance and increasing healthcare costs. This limitation hampers widespread adoption, especially in outpatient settings.

Competition from oral chelators

Oral formulations like deferasirox (approved in 2005) and deferiprone (approved in 1997) offer more convenience, reducing DFO’s market share. The latter has gained preference where compliance is critical.

Side effect profile

DFO's adverse effects, which include allergic reactions, ocular and auditory toxicity, discourage long-term use. These safety concerns influence prescriber and patient preferences.

Price pressures

Generic versions have reduced DFO prices, pressuring profit margins for manufacturers.

What is the financial outlook?

Revenue from Deferoxamine Mesylate is expected to stabilize or decline modestly due to market saturation and competition. Meanwhile, manufacturers investing in derivative formulations or novel delivery methods might find growth opportunities.

Research into improved delivery systems, including sustained-release formulations or inhalational options, could open new revenue streams.

How will regulatory and patent trends influence the market?

Deferoxamine is subject to minimal patent protections, paving the way for generics and reducing prices. Regulatory agencies focus on safety profiles; advances in formulation that lower toxicity or improve administration could facilitate accelerated approvals, creating competitive advantages.

Key competitors and their strategies

Company	Product/Portfolio	Market Focus	Strategy
Novartis	Desferal (brand name for DFO)	Global	Maintains generic supply, explores delivery innovation
Spectrum Pharmaceuticals	Desferal (generic)	North America, Europe	Cost competitiveness, expanding access
Sandoz (Novartis subsidiary)	Generic DFO	Global	Price reduction, supply chain expansion

Summary

Deferoxamine Mesylate remains a cornerstone treatment for iron overload, primarily in transfusion-dependent patients. Its market faces headwinds from oral alternatives, administration challenges, and safety concerns, limiting growth prospects. Generic competition ensures low prices, constraining revenue expansion. Innovation in delivery methods may create niche opportunities, but widespread adoption of newer agents diminishes DFO’s market dominance.

Key Takeaways

• The DFO market is valued around USD 200 million (2022), growing modestly.
• Major growth drivers include rising diseased population and improved diagnosis.
• Challenges include mode of administration, competition from oral chelators, and safety profile.
• Patents are expired; generics dominate, exerting price pressure.
• Innovation in delivery systems could open transitional growth pathways.

FAQs

1. What conditions are primarily treated with deferoxamine mesylate?
   Iron overload due to frequent transfusions, including thalassemia major and sickle cell anemia.

2. Are generic versions of deferoxamine available?
   Yes, multiple manufacturers produce generic DFO, reducing prices globally.

3. How does administration mode impact patient compliance?
   The need for parenteral infusion limits convenience, often leading to poor adherence compared to oral alternatives.

4. What are the main competitors to deferoxamine?
   Oral iron chelators such as deferasirox and deferiprone.

5. What future opportunities exist for deferoxamine?
   Development of sustained-release formulations or inhalational delivery could improve compliance and expand use.

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References

1. Research and Markets. (2023). Global Deferoxamine Market Analysis. Retrieved from https://www.researchandmarkets.com/
2. World Health Organization. (2022). Genetic Blood Disorders Report. Retrieved from https://www.who.int
3. U.S. Food and Drug Administration. (2022). Drug Approvals and Labeling.