DEFERIPRONE - Generic Drug Details

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

Deferiprone is the generic ingredient in two branded drugs marketed by Chiesi, Hikma, and Taro, and is included in five NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Deferiprone has sixty-one patent family members in thirty-three countries.

There are four drug master file entries for deferiprone. Three suppliers are listed for this compound.

Summary for DEFERIPRONE

International Patents:	61
US Patents:	7
Tradenames:	2
Applicants:	3
NDAs:	5
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	65
Patent Applications:	4,550
Drug Prices:	Drug price trends for DEFERIPRONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DEFERIPRONE
What excipients (inactive ingredients) are in DEFERIPRONE?	DEFERIPRONE excipients list
DailyMed Link:	DEFERIPRONE at DailyMed

See drug prices for DEFERIPRONE

Recent Clinical Trials for DEFERIPRONE

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

Sponsor	Phase
Inova Health Care Services	PHASE2
National Institute of Blood and Marrow Transplant (NIBMT), Pakistan	PHASE2
Assiut University	Phase 1

See all DEFERIPRONE clinical trials

Pharmacology for DEFERIPRONE

Drug Class	Iron Chelator
Mechanism of Action	Iron Chelating Activity

Anatomical Therapeutic Chemical (ATC) Classes for DEFERIPRONE

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

Paragraph IV (Patent) Challenges for DEFERIPRONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FERRIPROX	Tablets	deferiprone	500 mg	021825	1	2016-01-29

US Patents and Regulatory Information for DEFERIPRONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	DEFERIPRONE	deferiprone	TABLET;ORAL	213239-002	Feb 8, 2022	AB	RX	No	Yes
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-001	Sep 9, 2015		RX	Yes	Yes
Hikma	DEFERIPRONE	deferiprone	TABLET;ORAL	213239-001	Mar 29, 2021	AB	RX	No	No
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-001	Sep 9, 2015		RX	Yes	Yes	8,703,156		Y
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-002	Apr 20, 2018		DISCN	Yes	No
Taro	DEFERIPRONE	deferiprone	TABLET;ORAL	208800-002	Nov 22, 2023	AB	RX	No	No
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	212269-001	May 19, 2020		RX	Yes	Yes	11,357,731

Expired US Patents for DEFERIPRONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-001	Sep 9, 2015	7,049,328
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	021825-002	Jul 25, 2019	7,049,328
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-002	Apr 20, 2018	7,049,328
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	212269-001	May 19, 2020	7,049,328
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	021825-001	Oct 14, 2011	7,049,328

EU/EMA Drug Approvals for DEFERIPRONE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Chiesi Farmaceutici S.p.A.	Ferriprox	deferiprone	EMEA/H/C/000236Ferriprox monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.Ferriprox in combination with another chelator is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload (mainly cardiac overload) justifies rapid or intensive correction.	Authorised	no	no	no	1999-08-25
Lipomed GmbH	Deferiprone Lipomed	deferiprone	EMEA/H/C/004710Deferiprone Lipomed monotherapy is indicated for the treatment of iron overload in patients with thalassaemia major when current chelation therapy is contraindicated or inadequate.Deferiprone Lipomed in combination with another chelator is indicated in patients with thalassaemia major when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload justifies rapid or intensive correction.	Authorised	yes	no	no	2018-09-19

International Patents for DEFERIPRONE

Country	Patent Number	Title	Estimated Expiration
Canada	2722393
China	114533689
China	111918646
Canada	3172668
Saudi Arabia	520411808	أقراص ديفيريبرون مؤخرة الإطلاق وطرق لاستخدامها (Delayed Release Deferiprone Tablets and Methods of Using The Same)
Hong Kong	1152871
Denmark	3684344

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Deferiprone

Last updated: July 27, 2025

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Introduction

Deferiprone, an oral iron chelator primarily used in managing iron overload, has garnered strategic interest within the pharmaceutical industry due to its unique therapeutic profile and unmet clinical needs. As iron overload conditions, including hereditary hemochromatosis, thalassemia, and sickle cell disease, continue to pose treatment challenges worldwide, Deferiprone’s market dynamics and financial trajectory are poised for significant evolution. This analysis dissects the current landscape, anticipated growth drivers, competitive positioning, and financial outlook for Deferiprone, providing clarity for stakeholders.

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Market Overview

Deferiprone’s pharmaceutical niche centers on chelation therapy, targeting patients with excessive iron accumulation resulting from frequent transfusions or metabolic disorders. Since its approval in multiple countries (notably Europe and India) in the late 1990s and early 2000s, Deferiprone has established a dedicated patient base, especially in regions where alternatives like deferoxamine (injectable) are less feasible.

The global iron chelation therapy market, valued at approximately US$2.1 billion in 2022, is projected to grow at a CAGR of around 7% through 2030 [1]. Deferiprone’s market share, though historically limited compared to deferoxamine and deferasirox, has shown signs of expansion, driven by its oral administration and potent efficacy in cardiac iron removal.

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Market Dynamics

Growth Drivers

• Unmet Clinical Needs: Despite existing therapies, there remains a subset of patients unresponsive or intolerant to current chelators. Deferiprone has demonstrated superior efficacy in cardiac iron removal, a leading cause of morbidity and mortality in transfusion-dependent patients [2].

• Regulatory Approvals and Off-Label Use: Expanding approvals, especially in emerging markets, alongside growing clinicians’ familiarity, bolster adoption. Additionally, investigator-sponsored trials underscore ongoing interest in expanding indications.

• Emerging Biomarkers and Diagnostics: Improved detection of organ-specific iron overload increases demand for targeted chelation, benefitting Deferiprone’s profile.

Challenges

• Safety Concerns: Risks such as agranulocytosis, although manageable with monitoring, hinder broader acceptance. These safety issues necessitate rigorous patient management protocols, impacting market penetration.

• Competition: Deferiprone faces stiff competition from deferoxamine and deferasirox, which dominate in many geographies due to established clinical data and broader marketing.

• Pricing and Access: Variability in healthcare reimbursement, particularly in low-income and middle-income countries, affects market expansion.

Regulatory and Policy Environment

Regulatory pathways and approval status significantly influence Deferiprone’s commercial trajectory. While licensed in Europe and India, its approval in the United States remains pending or limited, restricting access in the world's largest pharmaceutical market. Ongoing clinical trials and post-marketing surveillance are critical for expanding regulatory clearance.

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Financial Trajectory

Revenue Streams

Currently, Deferiprone’s revenues stem from branded formulations, generic versions, and licensing agreements. In markets where it is approved, sales are primarily driven by hematology and oncology clinics. As awareness increases and indications potentially broaden, revenues are projected to grow substantially.

Forecasted Growth

Analyst projections estimate that Deferiprone’s global sales could reach US$500 million by 2030, representing a CAGR of 12-15% from 2022 (approximate figures based on industry reports) [3]. This growth hinges on:

• Expansion into new markets, especially North America.
• Development of extended-release formulations reducing dosing frequency.
• Strategic collaborations and licensing aligning with emerging clinical evidence.

Investment and R&D Outlook

Pharmaceutical companies are investing in research to improve Deferiprone’s safety profile and optimize dosing—to facilitate wider adoption. Partnerships with biotech firms aim to develop combination therapies and biomarkers for personalized chelation regimens, which may enhance efficacy and market penetration.

Pricing Strategies

Pricing remains critical in determining market accessibility. While premium pricing yields higher margins in developed markets, adoption in emerging economies depends on pricing competitiveness and generics’ availability.

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Competitive Landscape

Deferiprone competes with several chelators:

• Deferoxamine: The historical gold standard, administered via infusion, limiting adherence.
• Deferasirox: An oral agent with broader approval but concerns over kidney and hepatic toxicity.
• Emerging Therapies: Researchers are exploring novel chelators with improved safety profiles or dual-action agents.

Market positioning of Deferiprone emphasizes its cardiac iron removal efficacy and oral convenience. Strategic differentiation focuses on safety management programs and combination therapy trials.

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Opportunities and Outlook

Expansion strategies include:

• Regulatory Approvals in the US: A critical step to access the world’s largest market, driven by ongoing Phase III trials demonstrating safety and efficacy.
• Indication Expansion: Investigating use in non-transfusion-dependent iron overload and other disorders such as neurodegenerative diseases.
• Formulation Innovations: Developing long-acting or targeted delivery systems to improve compliance.
• Global Access Programs: Collaborations with health agencies to facilitate affordability in low- and middle-income countries.

Investment in clinical development, coupled with proactive safety monitoring, is vital for sustainable growth. The current trajectory indicates a cautiously optimistic forecast, contingent upon regulatory outcomes and market acceptance.

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Key Takeaways

• Growing Demand: Rising prevalence of iron overload conditions combined with patient preference for oral therapies positions Deferiprone favorably over injectable alternatives.
• Regulatory Expansion Needed: Approval in the United States remains pivotal to unlocking maximal growth potential.
• Safety Management: Addressing safety concerns through improved formulations and monitoring is essential to increase clinician confidence.
• Market Competition: Competitive differentiation relies heavily on efficacy, safety profile, and access strategies.
• Strategic Collaborations: Licensing, partnerships, and indications expansion will carve new revenue streams and solidify market presence.

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FAQs

1. What are the key factors influencing Deferiprone's market growth?
Market growth depends on regulatory approvals, safety profile improvements, the expansion of indications, clinician acceptance, and competitive positioning against other chelators.

2. How does Deferiprone compare to other iron chelators in terms of efficacy?
Deferiprone shows superior efficacy in cardiac iron removal, particularly in transfusion-dependent patients, although it shares similar safety concerns with other chelators.

3. What regulatory hurdles does Deferiprone face?
Deferiprone's major hurdle is gaining approval in the US, where data submission is ongoing or awaiting FDA review. Additionally, post-marketing safety monitoring remains critical.

4. What emerging trends could impact Deferiprone’s future market?
Advancements in iron overload diagnostics, biotechnological innovations in chelation, and personalized medicine approaches are expected to enhance Deferiprone’s marketability.

5. What strategies should stakeholders consider to capitalize on Deferiprone’s potential?
Stakeholders should focus on clinical development, safety optimization, market expansion through licensing, and building access programs, especially in underserved regions.

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References

[1] Allied Market Research, "Iron Chelation Therapy Market," 2022.
[2] Porter JB. “Deferiprone: clinical pharmacology and utilization,” Hematology Reports, 2021.
[3] GlobalData, “Pharma Market Insight,” 2022.