FERRIPROX Drug Patent Profile

When do Ferriprox patents expire, 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. Three 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
SocraMetrics 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
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-002	Apr 20, 2018		DISCN	Yes	No

Expired US Patents for FERRIPROX

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

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
Canada	2313270	UTILISATION DE DEFERIPRONE POUR LE TRAITEMENT ET LA PREVENTION DE MALADIES CARDIAQUES INDUITES PAR LE FER (USE OF DEFERIPRONE IN TREATING AND PREVENTING IRON-INDUCED CARDIAC DISEASE)
Slovenia	3684344
Cyprus	1116146
Australia	2018357350
World Intellectual Property Organization (WIPO)	2019082128
Croatia	P20150083
Moldova, Republic of	3684344

Market Dynamics and Financial Trajectory for FERRIPROX

Last updated: July 27, 2025

Introduction

FERRIPROX (deferiprone) is an oral iron chelator developed primarily for treating iron overload conditions, such as thalassemia and other transfusion-dependent anemias. Since its FDA approval in 2011 and subsequent global adoption, FERRIPROX's market dynamics are shaped by evolving clinical needs, regulatory landscapes, competitive forces, and manufacturing considerations. This article offers a comprehensive analysis of the market forces influencing FERRIPROX’s current and future financial trajectory.

Market Overview and Clinical Context

Iron overload remains a significant complication in patients receiving chronic blood transfusions. The global prevalence of transfusion-dependent anemia, especially thalassemia, is projected to increase, driven by demographic factors and improved survival rates. Conventional treatments include deferoxamine (parenteral) and newer oral agents like FERRIPROX and deferasirox. The oral administration route of FERRIPROX provides a user-friendly alternative to parenteral agents, boosting adherence and expanding its market reach.

Market Dynamics

1. Market Demand Drivers

• Prevalence of Transfusion-Dependent Anemias: The rising burden of thalassemia in Southeast Asia, the Middle East, and parts of Africa sustains demand for effective iron chelation therapy. The World Health Organization estimates millions affected worldwide, with approximately 100,000 new cases annually [1].

• Advances in Patient Management: Improved survival rates in transfusion-dependent patients intensify the need for long-term iron chelation, elevating FERRIPROX's relevance.

• Safety Profile and Compliance: Compared to deferoxamine, FERRIPROX's oral regimen enhances patient compliance, potentially improving clinical outcomes and market share.

2. Competitive Landscape

• Key Competitors: FERRIPROX faces competition from deferasirox (Exjade, Jadenu) and deferoxamine. Deferasirox, marketed by Novartis and subsequently other generics, benefits from extensive clinical data and global branding.

• Differentiators and Limitations: FERRIPROX offers a unique oral formulation with a well-characterized safety profile, but its higher cost and the emergence of generic deferasirox influence market penetration.

3. Regulatory and Patent Considerations

• Patent Expiry and Generics: Patent expiration in major markets could introduce more affordable generics, impacting FERRIPROX's pricing power and market share.

• Regulatory Approvals: Its approval status varies across jurisdictions, influencing global distribution and prescribing practices. As of 2023, FERRIPROX remains approved in select countries, including the US, Europe, and emerging markets.

4. Pricing and Reimbursement

• Pricing Strategies: FERRIPROX’s pricing reflects its status as a branded, specialized medication. Price sensitivity in emerging markets and reimbursement policies significantly impact sales volume.

• Reimbursement Policies: Health insurance coverage, especially in developed nations, bolsters access, while limited reimbursement in low-income countries constrains market expansion.

5. Manufacturing and Supply Chain Factors

• Manufacturing Costs: Consistent production quality and cost management are critical, especially with potential generic competition.

• Supply Chain Stability: Reliable supply chains ensure uninterrupted access, essential for chronic therapy regimens.

Financial Trajectory and Revenue Forecasts

1. Historical Financial Performance

FERRIPROX’s initial sales post-approval demonstrated steady growth in markets with established hematology programs. However, margins have been affected by pricing pressures and market competition. Ownership changes, with Pfizer’s divestment of deferiprone assets, have created market fragmentation.

2. Forecasting Future Revenue

• Growth Prospects: The expanding global iron overload population suggests a positive long-term outlook. Estimated compound annual growth rates (CAGR) range between 4-6% over the next five years, assuming continued demand and effective market strategies [2].

• Impact of Generic Competition: Entry of lower-cost generics could decrease prices by up to 30-50%, affecting profit margins. However, brand loyalty and clinical familiarity may sustain some premium pricing in certain markets.

• Market Penetration Strategies: Enhanced physician awareness, expanded indications, and patient adherence programs can drive incremental sales.

3. Risks and Challenges

• Competitive Displacement: The aggressive pricing of deferasirox generics threatens FERRIPROX’s market share.

• Regulatory Hurdles: Delays or denials in market extensions can restrict growth.

• Limited Global Reach: Slow expansion into emerging markets with high unmet needs limits future revenue streams.

Strategic Considerations

• Differentiation: Emphasizing FERRIPROX’s safety profile and ease of use can bolster its attractiveness.

• Partnerships: Collaborations with regional distributors and specialty care providers can enhance access.

• Manufacturing Efficiency: Cost reductions through technological innovations can improve margins amid price erosion.

Key Takeaways

• The global burden of transfusion-dependent anemia positively influences long-term demand for FERRIPROX.

• Competitive pressures from cheaper, established generics are pivotal in shaping its financial trajectory.

• Strategic market expansion, adherence programs, and clinical differentiation are essential for sustained growth.

• Regulatory developments and patent landscapes are critical determinants of future revenue streams; proactive engagement can mitigate risks.

• Cost management and partnership formations capacity are vital to navigating evolving market dynamics.

Conclusion

FERRIPROX’s market and financial outlook hinges on its ability to maintain clinical relevance amidst mounting competition and shifting regulatory frameworks. Its future growth depends on strategic positioning, geographic expansion, and cost efficiencies. Given the rising global prevalence of iron overload conditions, FERRIPROX holds significant long-term potential when managed with a focus on innovation and market agility.

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FAQs

1. How does FERRIPROX’s efficacy compare to other iron chelators?
FERRIPROX demonstrates comparable efficacy to deferasirox and deferoxamine in reducing iron overload, with a favorable safety profile. Its oral administration facilitates adherence, especially in pediatric and adult populations requiring long-term therapy [1].

2. What are the main side effects associated with FERRIPROX?
Common adverse effects include gastrointestinal disturbances, neutropenia, and liver enzyme elevations. Regular blood monitoring is recommended to mitigate risks, particularly neutropenia, which can be severe in rare cases.

3. How might patent expiry affect FERRIPROX’s market share?
Patent expiration could enable generic manufacturers to introduce lower-cost alternatives, pressuring pricing and potentially reducing market share. The brand’s sustained success depends on clinical differentiation and geographic market development.

4. Which regions present the most growth opportunities for FERRIPROX?
Emerging markets in Southeast Asia, Africa, and the Middle East, where transfusion-dependent anemia prevalence is high, offer significant growth potential, provided distribution and reimbursement systems are optimized.

5. What strategies can pharmaceutical companies adopt to enhance FERRIPROX’s market position?
Strategies include expanding indications, strengthening healthcare provider education, fostering patient adherence programs, reducing manufacturing costs, and forming regional partnerships to improve market access.

References

[1] World Health Organization. "Thalassemia." WHO Bulletin, 2020.
[2] Market Research Future. "Global Iron Chelators Market Analysis," 2022.