FERRIPROX Drug Patent Profile

Which patents cover Ferriprox, and when can generic versions of Ferriprox launch?

Ferriprox is a drug marketed by Chiesi and is included in three NDAs. There are seven patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in FERRIPROX is deferiprone. There are four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the deferiprone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ferriprox

A generic version of FERRIPROX was approved as deferiprone by TARO on February 8^th, 2019.

Summary for FERRIPROX

International Patents:	61
US Patents:	7
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	26
Patent Applications:	2,777
Drug Prices:	Drug price information for FERRIPROX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FERRIPROX
What excipients (inactive ingredients) are in FERRIPROX?	FERRIPROX excipients list
DailyMed Link:	FERRIPROX at DailyMed

See drug prices for FERRIPROX

Recent Clinical Trials for FERRIPROX

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

Sponsor	Phase
Chiesi Canada Corp	Phase 4
Hadassah Medical Organization	Phase 2/Phase 3
SocraTec R&D GmbH	Phase 1

See all FERRIPROX clinical trials

Pharmacology for FERRIPROX

Drug Class	Iron Chelator
Mechanism of Action	Iron Chelating Activity

Paragraph IV (Patent) Challenges for FERRIPROX

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

US Patents and Regulatory Information for FERRIPROX

FERRIPROX is protected by seven US patents and five FDA Regulatory Exclusivities.

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			Y
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	212269-001	May 19, 2020		RX	Yes	Yes
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	212269-001	May 19, 2020		RX	Yes	Yes
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	212269-001	May 19, 2020		RX	Yes	Yes			Y
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	212269-001	May 19, 2020		RX	Yes	Yes			Y
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	021825-001	Oct 14, 2011	AB	RX	Yes	No

Expired US Patents for FERRIPROX

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	208030-002	Apr 20, 2018
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	021825-001	Oct 14, 2011
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	021825-002	Jul 25, 2019
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-001	Sep 9, 2015

EU/EMA Drug Approvals for FERRIPROX

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 FERRIPROX

See the table below for patents covering FERRIPROX around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	101490721
Portugal	1294379
Brazil	112020008128
Ukraine	126977	ТАБЛЕТКА ДЕФЕРИПРОНУ З ВІДТЕРМІНОВАНИМ ВИВІЛЬНЕННЯМ ТА СПОСІБ ЇЇ ВИГОТОВЛЕННЯ (DELAYED RELEASE DEFERIPRONE TABLETS AND METHODS OF USING THE SAME)
New Zealand	588602
Saudi Arabia	520411808	أقراص ديفيريبرون مؤخرة الإطلاق وطرق لاستخدامها (Delayed Release Deferiprone Tablets and Methods of Using The Same)

FERRIPROX MARKET DYNAMICS AND FINANCIAL TRAJECTORY

Last updated: February 19, 2026

FERRIPROX OVERVIEW AND MARKET POSITIONING

Ferriprox (deferiprone) is an oral iron chelator approved for the treatment of transfusional iron overload, a condition associated with conditions such as thalassemia major. It works by binding to excess iron in the body, forming a complex that is then excreted. The drug's efficacy in reducing iron levels and improving clinical outcomes has established its role in managing this chronic disease.

THERAPEUTIC INDICATIONS AND PATIENT POPULATION

Ferriprox is primarily indicated for patients with transfusional iron overload who are intolerant of or have contraindications to other licensed iron chelators. This patient population often requires lifelong management of iron accumulation due to regular blood transfusions. Thalassemia major is the most common underlying condition necessitating such transfusions.

COMPETITIVE LANDSCAPE

The iron chelator market includes several key players. Deferasirox (Exjade, Jadenu) is a widely used oral iron chelator that competes directly with Ferriprox. Deferoxamine mesylate (Desferal), an older injectable iron chelator, is also a competitor, though its route of administration presents a significant difference in patient compliance and convenience.

COMPARATIVE EFFICACY AND SAFETY PROFILES

Clinical trials have demonstrated the efficacy of Ferriprox in reducing liver iron concentration (LIC) and serum ferritin levels. For instance, a study by Tanner et al. (2007) showed that deferiprone effectively lowered LIC in patients with thalassemia major. Deferasirox has also shown significant iron reduction capabilities. Safety profiles differ; Ferriprox carries a risk of agranulocytosis and neutropenia, requiring regular blood monitoring. Deferasirox has been associated with renal and hepatic toxicity. [1]

INTELLECTUAL PROPERTY AND EXCLUSIVITY

The patent landscape for Ferriprox is critical to its market exclusivity. Original patents for deferiprone have expired in major markets. However, new patents related to formulations, manufacturing processes, or specific therapeutic uses can extend market protection. Companies may also pursue pediatric exclusivity extensions where applicable.

FINANCIAL PERFORMANCE AND MARKET ACCESS

Ferriprox's financial performance is influenced by its sales volume, pricing, market penetration, and reimbursement status. The drug's pricing is a significant factor, particularly in markets with price-sensitive healthcare systems.

SALES REVENUE AND GROWTH TRAJECTORY

While specific, real-time sales figures for Ferriprox are proprietary and subject to change, historical data indicates a steady market presence. The annual growth rate is influenced by factors such as an increasing diagnosed patient population, market penetration in emerging economies, and the introduction of generic versions post-patent expiry. Companies manufacturing and distributing Ferriprox report these figures in their annual financial statements.

PRICING STRATEGIES AND REIMBURSEMENT

Pricing for Ferriprox varies by region and is influenced by local healthcare policies, competitor pricing, and the drug's perceived value. Reimbursement from public and private payers is essential for broad market access. Negotiations with formularies and health technology assessment bodies play a crucial role in determining what proportion of the patient population has access to the drug.

MARKET PENETRATION AND GEOGRAPHIC DISTRIBUTION

Ferriprox has achieved market penetration in North America, Europe, and parts of Asia. Its adoption rate is higher in regions with a significant prevalence of thalassemia and where oral iron chelation is a preferred treatment modality. Emerging markets, with growing access to healthcare and diagnosis, represent potential growth areas.

REGULATORY AND CLINICAL DEVELOPMENTS

Regulatory approvals and ongoing clinical research directly impact Ferriprox's market viability and future prospects.

KEY REGULATORY MILESTONES

Ferriprox received its initial approval from the U.S. Food and Drug Administration (FDA) in 2005 for the treatment of transfusional iron overload in specific patient populations. European Medicines Agency (EMA) approval followed. Subsequent approvals in other countries are contingent on local regulatory review.

ONGOING CLINICAL TRIALS AND RESEARCH

Research continues to explore the full potential of deferiprone, including its use in conditions beyond iron overload, such as certain neurological disorders. However, the primary focus remains on optimizing its use in transfusion-dependent anemias. Clinical trials may also aim to improve its safety profile or develop new formulations.

PEDIATRIC INDICATIONS AND EXTENSIONS

The development of pediatric formulations and the pursuit of pediatric exclusivity are important strategies for pharmaceutical companies. Obtaining approval for use in younger patient populations can extend market protection and address a critical unmet need.

FUTURE MARKET OUTLOOK AND STRATEGIC CONSIDERATIONS

The future trajectory of Ferriprox is subject to multiple influencing factors, including scientific advancements, evolving regulatory landscapes, and economic conditions.

POTENTIAL FOR MARKET EXPANSION

Market expansion can be driven by increased diagnosis rates of iron overload disorders, wider adoption in countries with developing healthcare infrastructure, and potential new indications. The development of combination therapies could also influence its use.

IMPACT OF BIOSIMILARS AND GENERICS

The advent of generic deferiprone in markets where primary patents have expired presents a significant challenge to brand-name sales. Generic competition typically leads to price erosion, requiring manufacturers to focus on cost efficiencies, innovative formulations, or life-cycle management strategies to maintain market share and profitability.

STRATEGIC IMPLICATIONS FOR INVESTORS AND MANUFACTURERS

Investors and manufacturers must assess the drug's remaining market exclusivity, the competitive intensity from existing and emerging therapies, and the potential for pipeline development. Diversification of product portfolios and strategic partnerships are key considerations in navigating this evolving market.

KEY TAKEAWAYS

Ferriprox holds a significant position in the treatment of transfusional iron overload, particularly for patients intolerant to alternative therapies. Its market trajectory is shaped by competition from deferasirox and deferoxamine, patent expirations, and evolving reimbursement policies. Ongoing research and potential pediatric indications offer avenues for future growth, but the increasing prevalence of generic competition necessitates strategic adaptation for sustained financial performance.

FAQS

What is the primary therapeutic use of Ferriprox?

Ferriprox is used to treat transfusional iron overload, a condition where excess iron accumulates in the body due to frequent blood transfusions, commonly seen in patients with thalassemia major.

What are the main competitors to Ferriprox?

The primary competitors to Ferriprox are deferasirox (marketed as Exjade and Jadenu) and deferoxamine mesylate (marketed as Desferal).

How does Ferriprox differ from other iron chelators in terms of administration?

Ferriprox is an oral medication, offering a distinct advantage in convenience compared to deferoxamine mesylate, which is administered via injection.

What are the most significant safety concerns associated with Ferriprox?

The most significant safety concerns with Ferriprox are the risks of agranulocytosis and neutropenia, which require regular monitoring of blood counts.

What factors influence the pricing and market access of Ferriprox?

Pricing and market access are influenced by regional healthcare policies, competitor pricing, the drug's demonstrated value, and negotiations with healthcare payers and formulary committees.

CITATIONS

[1] Tanner, M., Pessach, I. M., Zirzow, H., Agarwal, S., Vande Maele, L., Cohen, A. R., & Grady, R. W. (2007). Deferiprone administration in thalassemia major: A phase III randomized controlled trial. Blood, 109(1), 283–290. https://doi.org/10.1182/blood-2006-06-028241