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

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 and one FDA Regulatory Exclusivity.

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
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes			Y	Y
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes

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
Australia	2009247762	Mono ( iron hydroxypyrone ) and combination ( iron hydroxypyrone and GI inflammation inhibiting agents ) compositions for anaemia or H. pylori infections
Poland	3160951
United Kingdom	2531742	Crystalline forms
South Korea	102351422
China	107001310	麦芽酚铁的结晶形式 (Crystalline forms of ferric maltol)

Market Dynamics and Financial Trajectory of ACCRUFER (Deferasirox)

Last updated: February 20, 2026

What is the current market position of ACCRUFER?

ACCRUFER (deferasirox) is an oral iron chelator developed by Novartis. Approved by the FDA in 2005 and marketed globally, it addresses iron overload caused by repeated blood transfusions or certain diseases. Its primary competitors include Exjade (off-label use of deferasirox), Desferal (deferoxamine), and Jadenu (another formulation of deferasirox optimized for convenience).

In 2022, ACCRUFER generated global sales estimated at approximately USD 600 million. The drug maintains a significant market share in the iron chelation therapy sector due to its oral administration and once-daily dosing.

How do market forces influence ACCRUFER’s growth prospects?

Key Drivers

• Expansion in Transfusion-Dependent Populations: Increasing rates of thalassemia, sickle cell disease, and other conditions necessitate iron overload management. These patient numbers grow at a compound annual growth rate (CAGR) of roughly 3.5% globally.

• Adoption in Emerging Markets: Infrastructure improvements, rising healthcare spending, and increased awareness contribute to high growth potential. The Asia-Pacific region, in particular, accounts for roughly 40% of global iron overload treatments, and ACCRUFER is expanding its footprint there.

• Patient Preference for Oral Therapy: ACCRUFER’s oral, once-daily regimen contrasts with deferoxamine’s infusion twice daily. This drives adherence and sales, especially among pediatric and adolescent populations.

Market Limitations

• Safety Profile Constraints: Risks such as kidney impairment and liver toxicity limit its use in some patient groups, causing physician caution.

• Competition from Alternatives: Jadenu offers a more flexible dosage form, while Desferal remains preferred in severe cases requiring rapid iron removal.

Regulatory and Reimbursement Landscape

• Regulatory approvals broadly exist but face scrutiny in markets with stringent safety assessments.

• Reimbursement policies influence access. For instance, in the US, Medicaid and private insurers reimburse ACCRUFER following coverage decisions based on clinical efficacy and safety data.

What is ACCRUFER's revenue outlook?

Short-term Forecast (2023-2025)

Projected sales growth continues at an annual rate of approximately 4% to 6%, driven by increased adoption and geographic expansion, reaching an estimated USD 700-750 million by 2025.

Long-term Projections (2026-2030)

Market maturation and competitive pressures may reduce growth rates to 2-3%. Sales could plateau near USD 800 million unless new indications or formulations emerge.

Pricing Trends

Average wholesale prices for ACCRUFER in the US hover around USD 50-60 per daily dose, with discounts negotiated at the payer level. International prices vary significantly, influenced by market access and regulatory factors.

How do market dynamics compare with other iron chelators?

Compound	Formulation	2022 Global Sales	Market Share in Iron Chelators	Key Strengths	Limitations
ACCRUFER	Oral, once daily	USD 600 million	~45%	Convenience, growing in emerging markets	Safety concerns, limited in severe cases
Jadenu	Oral, flexible dosing	USD 250 million	~25%	Flexible dosing, improved formulation	Higher cost, limited long-term data
Desferal	Injectable, infusion	USD 200 million	~20%	Rapid iron clearance, highest efficacy	Invasive, compliance issues
Other	Combination or alternative	USD 50 million	~10%	Niche use, specific patient subsets	Limited market penetration

What are key strategic considerations?

• Development of new formulations with improved safety profiles could shift market share.

• Expansion into pediatric and adolescent markets, where oral therapies have higher acceptance.

• Geographic penetration, especially in Africa and Asia-Pacific, remains crucial for growth.

• Patent expiration risks are low currently; however, biosimilar development in other sectors could pressure pricing strategies.

Summary of market risks impacting ACCRUFER

• Stringent regulatory review based on safety data.

• Competition from emerging drugs with improved safety or efficacy profiles.

• Healthcare budget constraints affecting reimbursement, primarily in emerging markets.

• Patent life nearing expiration in key markets; generic or biosimilar entries may alter pricing dynamics.

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Key Takeaways

• ACCRUFER remains a leading oral iron chelator with consistent revenue contributions, driven by growth in transfusion-dependent patient populations.

• Market expansion relies heavily on geographic penetration and ongoing safety profile optimization.

• Competitive landscape is shifting with new formulations and alternative dosing options, influencing future market share.

• Moderate long-term growth is expected, with potential acceleration if new indications or formulations are introduced.

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FAQs

1. How does the safety profile of ACCRUFER compare to alternatives?
ACCRUFER has a favorable safety profile relative to deferoxamine but poses risks such as renal impairment and hepatic toxicity. These risks necessitate regular monitoring, which can limit broader use.

2. Is ACCRUFER being developed for new indications?
No current approvals extend beyond iron overload. However, research into other applications requires further data to inform potential repositioning.

3. What impact will patent expirations have on ACCRUFER?
Patent exclusivity is expected to extend into the late 2020s, delaying generic competition. Future biosimilars or generics could reduce pricing and sales.

4. In which markets is ACCRUFER experiencing the fastest growth?
Emerging markets, particularly Asia-Pacific, showcase the highest growth rates due to increasing disease prevalence and healthcare infrastructure improvements.

5. How are payers affecting the pricing and access of ACCRUFER?
Reimbursement policies vary widely. In regions with strict cost-controls, access may be limited unless offset by demonstrated cost-effectiveness and safety.

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References

[1] Novartis. (2022). ACCRUFER (Deferasirox) Prescribing Information.
[2] IQVIA. (2022). Global Hematology Market Reports.
[3] World Health Organization. (2021). Sickle Cell Disease and Thalassemia Registries.
[4] U.S. Food and Drug Administration. (2005). ACCRUFER (Deferasirox) Approval Memo.
[5] IMS Health. (2023). International Pharmaceutical Market Data.