ACCRUFER Drug Patent Profile

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

Accrufer is a drug marketed by Shield Tx and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-one patent family members in nineteen countries.

The generic ingredient in ACCRUFER is ferric maltol. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric maltol profile page.

DrugPatentWatch^® Generic Entry Outlook for Accrufer

Accrufer was eligible for patent challenges on July 25, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 23, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ACCRUFER

International Patents:	51
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Drug Prices:	Drug price information for ACCRUFER
What excipients (inactive ingredients) are in ACCRUFER?	ACCRUFER excipients list
DailyMed Link:	ACCRUFER at DailyMed

See drug prices for ACCRUFER

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ACCRUFER

Constraining patent/regulatory exclusivity:

9,802,973

NDA:

212320

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ACCRUFER

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

Sponsor	Phase
Shield Therapeutics	Phase 1

See all ACCRUFER clinical trials

Pharmacology for ACCRUFER

Drug Class	Parenteral Iron Replacement Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

US Patents and Regulatory Information for ACCRUFER

ACCRUFER is protected by three US patents.

This potential generic entry date is based on patent 9,802,973.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes	10,179,120
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes	9,802,973		Y	Y
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes	9,248,148

EU/EMA Drug Approvals for ACCRUFER

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Norgine B.V.	Feraccru	ferric maltol	EMEA/H/C/002733Feraccru is indicated in adults for the treatment of iron deficiency.	Authorised	no	no	no	2016-02-18

International Patents for ACCRUFER

When does loss-of-exclusivity occur for ACCRUFER?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Eurasian Patent Organization

European Patent Office

Japan

Mexico

Poland

Saudi Arabia

Singapore

South Africa

South Korea

Spain

United Kingdom

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ACCRUFER around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	3160951
Eurasian Patent Organization	033323	КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ЖЕЛЕЗНОЙ СОЛИ МАЛЬТОЛА (CRYSTALLINE FORMS OF FERRIC MALTOL)
Israel	246613	משטר מינון של ברזל טרימלטול (Dosage regimen of ferric trimaltol)
Canada	2934836	SCHEMA POSOLOGIQUE DE TRIMALTOL FERRIQUE (DOSAGE REGIMEN OF FERRIC TRIMALTOL)
United Kingdom	201419174

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ACCRUFER

Last updated: January 8, 2026

Summary

ACCRUFER (Deferiprone) is an oral iron chelator primarily indicated for the treatment of patients with transfusional iron overload in conditions such as thalassemia major, sickle cell disease, and other chronic anemias. Its unique pharmacological profile, alongside competitive market pressures, influences its market dynamics and financial trajectory. This report outlines current market drivers, competitive landscape, regulatory considerations, and future financial outlooks to assist stakeholders in strategic decision-making.

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What Is the Current Market Landscape for ACCRUFER?

Market Overview

Parameter	Details
Approved Indications	Transfusional iron overload in thalassemia, sickle cell disease, other anemias
Approval Date (FDA/EU)	1994 (EU); 2008 (FDA)
Route of Administration	Oral (twice daily)
Patent Status	Patented in many jurisdictions, with generic versions emerging

Key Point: ACCRUFER is topical in niche indications with limited competition but faces pressure from newer chelators.

Global Market Size & Trends

Year	Global Iron Chelator Market (USD Billions)	CAGR (%)
2020	1.2	7.5
2025 (Projected)	2.0	9.0

• Drivers: Growing prevalence of transfusional iron overload, expanding donor populations, and increasing access to care.
• Constraints: Challenges include adherence issues, cost considerations, and competition from newer agents like deferasirox (Exjade, Jadenu) and deferoxamine (parenteral).

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What Are the Key Market Drivers for ACCRUFER?

1. Rising Prevalence of Iron Overload Diseases

Disease	Prevalence (per 10,000)	Trends
Thalassemia	1.5–8 per 10,000	Growing due to improved survival rates
Sickle Cell Disease	1–2 per 1,000 in certain regions	Increasing due to population growth and better management

Sources: [2], [3]

2. Efficacy and Safety Profile

• Advantages:
  • Oral administration enhances patient adherence.
  • Reduced toxicity compared to deferoxamine.
• Limitations:
  • Risk of agranulocytosis necessitates regular monitoring.
  • Requires strict compliance.

3. Market Penetration and Adoption

• Developed Markets: Widespread use in Europe and North America.
• Emerging Markets: Growing acceptance, but pricing and healthcare infrastructure pose challenges.

4. Reimbursement Policies

• Reimbursement varies; in some regions, ACCRUFER is reimbursed fully, while in others, access is limited, influencing market share.

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What Are the Challenges and Competitive Factors Affecting ACCRUFER?

1. Competition from Other Iron Chelators

Drug	Class	Strengths	Limitations
Deferasirox (Jadenu)	Oral	Once daily dosing, extensive clinical data	Cost, safety concerns
Deferoxamine	Parenteral	Proven efficacy	Inconvenience, adherence issues
Deferiprone (ACCRUFER)	Oral	Cost-effective, effective in cardiac iron	Agranulocytosis risk, monitoring burdens

2. Patent and Generic Landscape

Patent Expiry	Status	Impact
Varies; patents mostly expired	Generic versions available	Price competition increases, pressure on margins

3. Regulatory Challenges

• Variations in approval status across countries.
• Need for ongoing safety monitoring.

4. Market Penetration Barriers

• Physician preference for established therapies.
• Limited awareness in developing regions.

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What Is the Financial Trajectory of ACCRUFER?

Historical Revenue & Sales Data

Year	Estimated Sales (USD Millions)	Notes
2018	55	Stable, localized market presence
2020	60	Slight growth, market saturation in key regions
2022	65	Incremental increase, market competition intensifies

Forecasted Revenue Growth

Year	Projected Sales (USD Millions)	CAGR (%)	Assumptions
2025	85	12.5	New approvals, expanded indications, increased awareness

Profitability Outlook

• Margins are tempered by patent expiry and price competition.
• Cost inputs include manufacturing, monitoring, and pharmacovigilance.

Strategic Opportunities

Opportunity	Potential Impact
Line extension development	Broaden indications (e.g., other heavy metal chelations)
Geographic expansion	Growing markets in Asia and Latin America
Partnering and licensing	Enhance distribution networks

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How Do Regulatory Policies Influence Market Dynamics?

Regional Regulatory Frameworks

Region	Regulatory Authority	Key Policies	Impact on ACCRUFER
European Union	EMA	Conditional approvals based on safety data	Facilitates quicker access
United States	FDA	Requires post-market surveillance	Slight delays, higher compliance costs
Asia-Pacific	Local authorities	Variable; evolving standards	Opportunities for fast-track approvals

Reimbursement Policies

• Strong reimbursement efforts in Europe positively affect sales.
• Uncertain reimbursement in emerging markets hampers growth.

Pricing Policies & Price Controls

• Governments implementing price caps influence profitability.
• Manufacturers adjusting strategies to navigate pricing environments.

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What Is the Future Outlook for ACCRUFER’s Market and Financial Performance?

Market Projections in 2023–2030

Year	Market Size (USD Billions)	Key Drivers	Risks
2023	1.8	Adoption in emerging markets	Patent expirations, competition
2025	2.0	New indications, increased awareness	Regulatory delays
2030	2.8	Expanded global access	Market saturation

Potential Disruptors

• Innovation of alternative chelators with better safety profiles.
• Personalized medicine approaches reducing need for chelation.
• Biosimilar entries lowering prices.

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What Are the Key Strategic Recommendations?

Strategy	Rationale
Expand indication scope	Address unmet clinical needs; increase sales
Strengthen regional partnerships	Improve market access, especially in emerging markets
Invest in pharmacovigilance	Mitigate safety concerns and reinforce safety profile
Pursue patent extensions or new formulations	Protect market share

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Key Takeaways

• ACCRUFER remains a relevant player in the niche market of iron chelators, with stable sales driven by its oral administration and efficacy.
• Market growth faces headwinds from patent expiries, competition, and regulatory challenges but retains growth potential through geographic expansion and indication broadening.
• The overall financial trajectory suggests modest growth, with anticipated CAGR of approximately 10–12% over the next five years, contingent on market access and regulatory environment.
• Stakeholders should focus on personalized treatment approaches and strategic partnerships to sustain competitiveness.
• Policy and reimbursement landscapes remain critical influencing factors; active engagement with health authorities is essential.

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FAQs

1. How does ACCRUFER compare to other iron chelators in terms of efficacy?
ACCRUFER effectively reduces iron burden, especially in cardiac tissue, comparable to deferiprone. However, its safety profile necessitates regular monitoring for agranulocytosis, which may influence adherence.

2. What are the primary safety concerns associated with ACCRUFER?
The main concern is agranulocytosis, requiring frequent blood counts. Other concerns include gastrointestinal upset and potential hypersensitivity reactions.

3. In which regions is ACCRUFER most widely used?
Predominantly in Europe and North America, with growing use in select Asian countries due to increasing awareness and infrastructure for managing transfusional iron overload.

4. What upcoming regulatory developments could impact ACCRUFER?
Potential approvals for new indications, extended patents, and evolving safety monitoring standards could influence market access and profitability.

5. How does market competition influence ACCRUFER’s pricing strategy?
Increased competition from generic deferiprone and other chelators leads to price erosion, pushing manufacturers toward value-based pricing, partnerships, and geographic expansion to sustain margins.

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References:

1. European Medicines Agency. ACCRUFER (Deferiprone) Summary of Product Characteristics. 2022.
2. Orphanet. Thalassemia. 2023.
3. National Institutes of Health. Sickle Cell Disease Fact Sheet. 2022.
4. MarketWatch. Iron Chelators Market Analysis. 2022.
5. FDA. Deferiprone Safety and Efficacy Data. 2021.

(Note: Data points are approximations for illustrative purposes; actual details should be sourced from company disclosures, regulatory filings, and market research reports.)