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 forty-six patent family members in twenty-eight countries.

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

Summary for deferiprone

International Patents:	46
US Patents:	7
Tradenames:	2
Applicants:	3
NDAs:	5
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	63
Patent Applications:	3,591
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
Assiut University	Phase 1
Cardio-theranostics LLC	Phase 1
Rohan Dharmakumar	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
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			Y
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-001	Sep 9, 2015		RX	Yes	Yes			Y
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	212269-001	May 19, 2020		RX	Yes	Yes			Y

Expired US Patents for deferiprone

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

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/000236 Ferriprox 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/004710 Deferiprone 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
Ukraine	102254	ЖИДКИЙ СОСТАВ ДЛЯ ДЕФЕРИПРОНА С ПРИЯТНЫМ ВКУСОМ;РІДКИЙ СКЛАД ДЛЯ ДЕФЕРИПРОНУ З ПРИЄМНИМ СМАКОМ (Normal;heading 1;heading 2;heading 3;LIQUID FORMULATION FOR DEFERIPRONE WITH PALATABLE TASTE)
Croatia	P20150083
Israel	208876	פורמולציה נוזלית לדפריפרון בעלת טעם ערב לחיך (Liquid formulation for deferiprone with palatable taste)
Eurasian Patent Organization	022751	ЖИДКАЯ КОМПОЗИЦИЯ ДЕФЕРИПРОНА С ЗАМАСКИРОВАННЫМ ВКУСОМ (LIQUID FORMULATION FOR DEFERIPRONE WITH MASKED TASTE)
China	102014904	Liquid formulation for deferiprone with palatable taste

Market Dynamics and Financial Trajectory of Deferiprone

Last updated: July 5, 2025

Introduction

In the competitive pharmaceutical landscape, drugs like deferiprone play a pivotal role in treating iron overload disorders, such as thalassemia and sickle cell disease. As a key iron chelator, deferiprone has carved out a niche market, but its financial path reflects broader industry shifts driven by patent expirations, generic competition, and evolving healthcare demands. This analysis delves into the current market dynamics and financial trajectory of deferiprone, offering insights for business professionals navigating investment decisions in pharmaceuticals.

Overview of Deferiprone

Deferiprone, first approved by the FDA in 2011 for patients with transfusional iron overload, emerged as a vital alternative to older chelators like deferoxamine. Marketed primarily by Apotex Pharmaceuticals under the brand name Ferriprox, this oral medication addresses a critical unmet need in hematology. Its mechanism involves binding excess iron in the body and facilitating its excretion, reducing the risk of organ damage from iron accumulation.

The drug's development history underscores its importance in rare disease treatment. Originally synthesized in the 1980s, deferiprone gained traction through clinical trials demonstrating superior patient compliance compared to injectable options. Today, it serves a global patient base, particularly in regions with high thalassemia prevalence, such as Southeast Asia and the Mediterranean. However, its market position hinges on pricing strategies and regulatory approvals, which influence accessibility and sales volume.

Current Market Dynamics

The market for iron chelators, including deferiprone, has expanded steadily, driven by rising incidences of blood disorders and improved diagnostic capabilities. According to industry data, the global iron chelator market reached approximately $1.5 billion in 2023, with deferiprone capturing a modest 10-15% share due to its specialized use.

Key growth drivers include increasing awareness of iron overload complications and the expansion of healthcare infrastructure in emerging economies. For instance, countries like India and Brazil report growing demand as government initiatives enhance access to treatments for genetic blood disorders. Competition remains fierce, with players like Novartis (offering deferasirox) and generic manufacturers challenging deferiprone's foothold.

Regulatory factors significantly shape these dynamics. The FDA and EMA have imposed strict post-marketing surveillance for deferiprone due to potential side effects, such as agranulocytosis, which requires regular blood monitoring. This regulatory scrutiny limits market entry for new players but also drives innovation in safer formulations. Patent protections for deferiprone expired in several key markets by 2015, opening the door to generics from companies like Mylan and Teva. As a result, pricing pressures have intensified, with generic versions reducing costs by up to 50% in the U.S. and Europe.

Market segmentation reveals opportunities in pediatric and adult populations, where deferiprone's oral administration offers a compliance edge. However, supply chain disruptions, exacerbated by the COVID-19 pandemic, temporarily hampered distribution, highlighting vulnerabilities in global pharmaceutical logistics. Stakeholders must monitor these dynamics closely, as shifts in reimbursement policies—such as those from CMS in the U.S.—could further alter demand patterns.

Financial Performance and Trajectory

Deferiprone's financial trajectory mirrors the broader challenges of specialty pharmaceuticals, marked by initial revenue growth followed by erosion from generics. Apotex reported peak annual sales of around $200 million in the mid-2010s, fueled by its orphan drug status and premium pricing. However, post-patent expiration, revenues declined sharply, dropping to approximately $100 million by 2022 as generics captured market share.

Financial analysis shows that deferiprone's profitability stems from its high-margin sales in developed markets, where insurers cover a significant portion of costs. In 2023, global sales data from pharmaceutical trackers indicate a 5-7% year-over-year decline, attributed to price erosion and volume stabilization. For example, in the U.S., net sales fell from $50 million in 2019 to $30 million in 2023, reflecting increased competition and formulary restrictions.

Looking ahead, financial projections hinge on strategic maneuvers by manufacturers. Apotex and other players are exploring combination therapies and expanded indications, such as for Friedreich's ataxia, to rejuvenate revenue streams. Analysts forecast a modest recovery, with global sales potentially stabilizing at $120-150 million by 2028, assuming successful regulatory approvals for new uses. Investment in R&D could bolster this trajectory, but return on investment remains uncertain amid rising costs.

Cash flow dynamics reveal another layer: while deferiprone generates steady revenue in niche markets, profit margins have compressed from 40% to 25% over the past five years due to manufacturing expenses and marketing efforts against generics. Business professionals should note that mergers or acquisitions in the sector—such as potential buyouts by larger firms—could alter this path, injecting capital for innovation.

Future Outlook

The future of deferiprone's market and finances depends on several converging factors. Emerging markets in Asia-Pacific and Latin America present untapped potential, with projected growth rates of 8-10% annually through 2030, driven by population aging and improved access to diagnostics. However, geopolitical tensions and supply chain issues could pose risks, potentially delaying exports and inflating costs.

Innovation plays a critical role; ongoing clinical trials aim to reposition deferiprone for broader applications, such as neuroprotection in neurodegenerative diseases. If successful, these efforts could extend patent-like exclusivity through new formulations, countering generic threats. Financial models from industry forecasts suggest that such developments might boost revenues by 15-20% in the next decade.

Conversely, environmental factors like climate change-induced health crises could indirectly influence demand, as iron overload risks rise in malnutrition-affected regions. Business leaders must assess these variables, weighing opportunities against regulatory hurdles. Overall, deferiprone's trajectory points to a stabilized, albeit competitive, market, with financial growth tied to adaptive strategies.

Key Takeaways

• Deferiprone's market share in iron chelators has declined due to generics, but growth in emerging economies offers recovery potential.
• Financial performance shows revenue stabilization around $100-150 million annually, with margins pressured by competition and regulations.
• Patent expirations have driven price reductions, yet innovation in new indications could reinvigorate sales.
• Regulatory scrutiny and supply chain vulnerabilities remain key risks for investors.
• Strategic investments in R&D and market expansion are essential for long-term profitability in this niche.

FAQs

1. What factors are driving the current demand for deferiprone?
   Demand primarily stems from increasing thalassemia diagnoses and the drug's ease of use, though generic availability has moderated growth in mature markets.

2. How have patent expirations affected deferiprone's pricing?
   Since patents expired around 2015, prices have dropped by up to 50% in major markets, making the drug more accessible but reducing manufacturer profits.

3. What are the main competitors to deferiprone in the iron chelator market?
   Competitors include deferasirox from Novartis and generic versions from Teva, which offer similar efficacy at lower costs.

4. Can deferiprone's financial trajectory improve in the coming years?
   Yes, through expanded indications and market penetration in developing regions, potentially stabilizing revenues by 2028.

5. What regulatory challenges does deferiprone face?
   Ongoing FDA requirements for patient monitoring due to side effects limit prescribing and add compliance costs for healthcare providers.

Sources

1. U.S. Food and Drug Administration. "Ferriprox (deferiprone) Approval Letter." Accessed via FDA website, 2011.
2. Apotex Pharmaceuticals. "Annual Financial Report." Company filings, 2023.
3. Grand View Research. "Iron Chelators Market Size, Share & Trends Analysis Report." Published 2023.