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:	2,844
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
Lipomed AG	Phase 1
Cardio-theranostics LLC	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	TABLET;ORAL	021825-002	Jul 25, 2019	AB	RX	Yes	No
Taro	DEFERIPRONE	deferiprone	TABLET;ORAL	208800-001	Feb 8, 2019	AB	RX	No	No
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	212269-001	May 19, 2020		RX	Yes	Yes	10,940,115		Y
Taro	DEFERIPRONE	deferiprone	TABLET;ORAL	208800-002	Nov 22, 2023	AB	RX	No	No

Expired US Patents for DEFERIPRONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	FERRIPROX	deferiprone	TABLET;ORAL	021825-001	Oct 14, 2011	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	021825-002	Jul 25, 2019	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/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
South Korea	101490721
Japan	7246384
Cyprus	1116146
Japan	2021500377	遅延放出デフェリプロン錠剤及びその使用法

DEFERIPRONE Market Analysis and Financial Projection Experimental

Deferiprone Market Dynamics and Financial Trajectory

Introduction

Deferiprone, marketed under the brand name Ferriprox, is an FDA-approved iron chelator used to treat iron overload in patients with conditions such as thalassemia and sickle cell disease. Here, we delve into the market dynamics and financial trajectory of deferiprone, highlighting key drivers, challenges, and future prospects.

Market Size and Growth

The deferiprone market is projected to experience steady growth over the coming years. 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].

Another forecast indicates that the market will reach USD 52.8 million by 2032, growing at a CAGR of 3.4% from 2022 to 2032[2].

Segmentation by Formulation

The deferiprone market is segmented by formulation into tablets, oral solutions, and capsules. In 2023, tablets dominated the market with a substantial 78.6% share, followed by oral solutions and capsules[1].

Therapeutic Indications

Deferiprone is primarily used to treat iron overload disorders, including transfusional iron overload and non-transfusion-dependent thalassemia (NTDT) caused iron overload. The Iron Overload Disorders segment held a significant 37.5% market share in 2023, driven by conditions like hemochromatosis and thalassemia[1].

Transfusional Iron Overload

This indication dominated the market with a 61.1% share in 2023, reflecting the high demand for deferiprone in managing iron accumulation resulting from frequent blood transfusions[1].

Sickle Cell Disease

The rising incidence of sickle cell disease is also a key driver, with the FDA approving deferiprone for treating iron overload in adult and pediatric patients with sickle cell anemia in May 2021[2].

Regional Analysis

North America

North America emerged as a dominant region in the deferiprone market, holding more than 39.1% of the market share in 2023. The robust healthcare infrastructure and increasing prevalence of iron overload disorders in this region contribute to its dominance[1].

Emerging Markets

Emerging markets, particularly in Asia Pacific, Latin America, and the Middle East & Africa, offer significant growth potential due to increasing healthcare awareness and improvements in healthcare infrastructure. These regions are expected to see a surge in demand for advanced healthcare solutions like deferiprone[1][2].

Key Drivers

Rising Prevalence of Iron Disorders

The increasing incidence of iron overload disorders such as thalassemia, hemochromatosis, and sickle cell disease is a major driver of the deferiprone market. Government initiatives and funding from private agencies further support market growth[2].

R&D Investments

Ongoing research and development investments are crucial for the market's expansion, as they lead to improved formulations and broader therapeutic applications of deferiprone[1].

Challenges

Adverse Reactions

Deferiprone is associated with adverse reactions, which can impact patient compliance and overall market growth. Managing these side effects is a significant challenge for healthcare providers and manufacturers[1].

Regulatory Approvals

Stringent regulatory approvals pose another obstacle. Ensuring the safety and efficacy of deferiprone through rigorous regulatory processes is essential but can be time-consuming and costly[1].

Patient Compliance

Patient compliance issues, such as adherence to treatment regimens, can also hinder market expansion. Educating patients and healthcare providers about the importance of consistent treatment is crucial[1].

Opportunities

Strategic Collaborations

Strategic collaborations between pharmaceutical companies and healthcare providers can enhance market penetration and improve patient outcomes. Partnerships can also facilitate the development of personalized medicine approaches[1].

Pediatric Applications

The FDA's approval of deferiprone for pediatric patients with sickle cell anemia opens up new market opportunities. Tailoring treatments for pediatric populations can significantly expand the market[2].

Emerging Markets

As mentioned earlier, emerging markets present a substantial growth opportunity due to their growing middle classes and increasing demand for advanced healthcare solutions[1].

Competitive Landscape

The deferiprone market is competitive, with several key players including:

• Cipla Limited
• Apotex Inc.
• Swedish Orphan Biovitrum AB (publ)
• Genepharm S.A.
• Lipomed AG
• Ambrosia Remedies (P) Ltd.[2]

These companies are focusing on expanding their market presence through new product launches, strategic partnerships, and geographic expansion.

Financial Trajectory

The financial trajectory of the deferiprone market is positive, with steady growth projected over the next decade. Here are some key financial metrics:

• 2023 Market Size: USD 38.3 million[1]
• 2033 Projected Market Size: USD 54 million[1]
• CAGR (2024-2033): 3.5%[1]
• 2022 Market Size: USD 37 million[2]
• 2032 Projected Market Size: USD 52.8 million[2]
• CAGR (2022-2032): 3.4%[2]

Key Takeaways

• The deferiprone market is driven by the increasing prevalence of iron overload disorders and ongoing R&D investments.
• North America is the dominant region, but emerging markets offer significant growth potential.
• Tablets are the leading formulation, and transfusional iron overload is the primary therapeutic indication.
• Adverse reactions, patient compliance issues, and stringent regulatory approvals are key challenges.
• Strategic collaborations, pediatric applications, and expansion into emerging markets present opportunities for growth.

FAQs

What is the primary use of deferiprone?

Deferiprone is primarily used to treat iron overload in patients with conditions such as thalassemia and sickle cell disease.

Which region dominates the deferiprone market?

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

What are the key drivers of the deferiprone market?

The key drivers include the rising prevalence of iron overload disorders, ongoing R&D investments, and government initiatives.

What are the main challenges facing the deferiprone market?

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

What opportunities exist for the deferiprone market?

Opportunities include strategic collaborations, pediatric applications, and expansion into emerging markets.

Sources

1. Market.us: Deferiprone Market Size, Share, and Growth | CAGR Of 3.5% [https://market.us/report/deferiprone-market/]
2. Einpresswire: Deferiprone Market is estimated to be US$ 52.8 million by 2032 [https://www.einpresswire.com/article/622068804/deferiprone-market-is-estimated-to-be-us-52-8-million-by-2032-by-pmi]
3. Valuates Reports: Global Deferiprone Market Insights, Forecast to 2030 [https://reports.valuates.com/market-reports/QYRE-Auto-19W657/global-deferiprone]