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 forty-six patent family members in twenty-eight 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:	46
US Patents:	7
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	125
Clinical Trials:	26
Patent Applications:	1,762
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 six 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	8,703,156		Y
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	212269-001	May 19, 2020		RX	Yes	Yes	10,780,055		Y
Chiesi	FERRIPROX	deferiprone	SOLUTION;ORAL	208030-001	Sep 9, 2015		RX	Yes	Yes

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	7,049,328
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	021825-001	Oct 14, 2011	7,049,328
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	021825-002	Jul 25, 2019	7,049,328

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/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 FERRIPROX

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

Country	Patent Number	Title	Estimated Expiration
Cyprus	1116146
Hong Kong	1152871	合口味的去鐵酮液體製劑 (LIQUID FORMULATION FOR DEFERIPRONE WITH PALATABLE TASTE)
Cyprus	1109191

FERRIPROX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for FERRIPROX (Deferiprone)

Introduction to FERRIPROX (Deferiprone)

FERRIPROX, marketed under the generic name deferiprone, is an FDA-approved iron chelator used to treat transfusional iron overload in patients with thalassemia syndromes, sickle cell disease, and other anemias. This drug is crucial for managing iron accumulation resulting from frequent blood transfusions.

Market Size and Growth

The deferiprone market is projected to experience steady growth. By 2033, the market is expected to reach approximately USD 54 million, up from USD 38.3 million in 2023, at a Compound Annual Growth Rate (CAGR) of 3.5% from 2024 to 2033[1][3].

Segment Dominance

In terms of formulation, tablets dominate the market, holding a substantial 78.6% market share in 2023, followed by oral solutions and capsules. The therapeutic focus is primarily on iron overload disorders, which commanded a 37.5% market share in 2023, driven by conditions like hemochromatosis. Transfusional iron overload is the leading indication, with a significant 61.1% market share in 2023[1].

Key Drivers of Market Growth

Several factors drive the growth of the deferiprone market:

• Rising Prevalence of Iron Disorders: The increasing incidence of iron overload disorders, such as thalassemia and hemochromatosis, is a significant driver.
• Ongoing R&D Investments: Continuous research and development in innovative therapeutic approaches and formulations contribute to market expansion.
• Government Initiatives and Funding: Government and private agency funding for rare disease research and treatment also boost market growth[1][3].

Challenges

Despite the growth, the market faces several challenges:

• Adverse Reactions: Deferiprone can cause adverse reactions, which may impact patient compliance.
• Patient Compliance Issues: Ensuring consistent patient adherence to the treatment regimen is a challenge.
• Stringent Regulatory Approvals: The rigorous regulatory environment can slow down market expansion[1].

Opportunities

The deferiprone market presents several opportunities for growth:

• Emerging Markets: Increasing healthcare awareness and improvements in healthcare infrastructure in emerging markets offer significant growth potential.
• Strategic Collaborations: Partnerships between pharmaceutical companies and healthcare providers can enhance market penetration.
• Personalized Medicine: Tailoring deferiprone treatments to individual patient needs can improve efficacy and compliance.
• Pediatric Applications: Expanding the use of deferiprone to pediatric patients with iron overload disorders is another growth area[1][3].

Regional Analysis

North America

North America is a dominant force in the deferiprone market, holding more than 39.1% of the market share in 2023. The region's advanced healthcare infrastructure, stringent regulatory environment, and high awareness among healthcare providers and patients contribute to its dominance. The market in North America is driven by the increasing prevalence of iron overload disorders such as thalassemia and hemochromatosis, and the region is expected to retain its leading position due to ongoing research and development activities[1].

Other Regions

Other regions, including Europe, Asia Pacific, Latin America, and the Middle East & Africa, also present growth opportunities. The rising middle classes in these regions and increasing healthcare expenditure are expected to drive demand for deferiprone[1][3].

Recent Developments and Approvals

• Extended-Release Formulation: Health Canada approved FERRIPROX MR deferiprone extended-release tablets in 2023, allowing for twice-daily dosing in patients with transfusional iron overload due to thalassemia syndromes, sickle cell disease, or other anemias[2].
• FDA Approvals: The FDA approved FERRIPROX for treating iron overload in patients with sickle cell disease in 2021, expanding its use beyond thalassemia syndromes[3].

Economic Evaluation

The economic evaluation of deferiprone indicates that while it offers improved quality-adjusted life-years (QALYs), it is associated with higher costs compared to other iron chelators like deferoxamine (DFO) and deferasirox (DFX). The incremental cost-effectiveness ratio (ICER) for deferiprone compared to DFX is significant, suggesting that a substantial price reduction would be necessary for it to be considered a cost-effective option[4].

Financial Trajectory

The financial trajectory of the deferiprone market is characterized by steady growth driven by increasing demand and expanding indications. Here are some key financial highlights:

• Current Market Size: USD 38.3 million in 2023.
• Projected Market Size: USD 54 million by 2033.
• CAGR: 3.5% from 2024 to 2033.
• Monthly Costs: The monthly cost of deferiprone can range from $6,113 for a low dose to $8,151 for a high dose, depending on the formulation and dosage[1][3][4].

Competitive Landscape

The deferiprone market is competitive, with several key players:

• Chiesi Global Rare Diseases: A leading player with significant investments in R&D and market expansion.
• Cipla Limited: Known for its generic formulations.
• Apotex Inc.: Another major player in the generic pharmaceutical market.
• Swedish Orphan Biovitrum AB (publ): Focuses on rare diseases and orphan drugs[3].

Key Takeaways

• The deferiprone market is growing steadily, driven by the increasing prevalence of iron overload disorders.
• North America dominates the market due to its advanced healthcare infrastructure and high awareness.
• Emerging markets offer significant growth opportunities.
• Recent approvals and new formulations are expanding the use of deferiprone.
• The drug faces challenges related to adverse reactions and patient compliance but offers improved QALYs.

FAQs

What is FERRIPROX (deferiprone) used for?

FERRIPROX (deferiprone) is used to treat transfusional iron overload in patients with thalassemia syndromes, sickle cell disease, and other anemias.

What is the projected market size of deferiprone by 2033?

The deferiprone market is projected to reach approximately USD 54 million by 2033[1].

What are the key drivers of the deferiprone market growth?

The key drivers include the rising prevalence of iron disorders, ongoing R&D investments, and government initiatives and funding for rare disease research[1][3].

What are the main challenges facing the deferiprone market?

The main challenges include adverse reactions, patient compliance issues, and stringent regulatory approvals[1].

Which region dominates the deferiprone market?

North America dominates the deferiprone market, holding more than 39.1% of the market share in 2023[1].

Sources:

1. Market.us: Deferiprone Market Size, Share, and Growth | CAGR Of 3.5%
2. PR Newswire: Chiesi Global Rare Diseases Announces Approval of FERRIPROX MR Deferiprone Extended-Release Tablets in Canada
3. Ein Presswire: Deferiprone Market is estimated to be US$ 52.8 million by 2032
4. NCBI: Pharmacoeconomic Review - Deferiprone (Ferriprox)