Ferric maltol - Generic Drug Details

What are the generic sources for ferric maltol and what is the scope of patent protection?

Ferric maltol is the generic ingredient in one branded drug marketed by Shield Tx and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ferric maltol has fifty-one patent family members in nineteen countries.

One supplier is listed for this compound.

Summary for ferric maltol

International Patents:	51
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	12
Patent Applications:	42
What excipients (inactive ingredients) are in ferric maltol?	ferric maltol excipients list
DailyMed Link:	ferric maltol at DailyMed

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

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 ferric maltol

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

Sponsor	Phase
Norgine	Phase 4
University Medical Center Groningen	Phase 4
Radboud University Medical Center	Phase 4

See all ferric maltol clinical trials

Pharmacology for ferric maltol

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

Anatomical Therapeutic Chemical (ATC) Classes for ferric maltol

B03AB	Iron trivalent, oral preparations
B03A	IRON PREPARATIONS
B03	ANTIANEMIC PREPARATIONS
B	Blood and blood forming organs

US Patents and Regulatory Information for ferric maltol

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			Y	Y
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

EU/EMA Drug Approvals for ferric maltol

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

International Patents for ferric maltol

Country	Patent Number	Title	Estimated Expiration
South Korea	102576930
Australia	2009247762	Mono ( iron hydroxypyrone ) and combination ( iron hydroxypyrone and GI inflammation inhibiting agents ) compositions for anaemia or H. pylori infections
Spain	2785391
Slovenia	3091974
Canada	2724172	COMPOSITIONS MONOCOMPOSE (D' HYDROXYPYRONE DE FER) ET DE COMBINAISON (D'HYDROXYPYRONE DE FER ET D'AGENTS INHIBITEURS D'INFLAMMATION GASTRO-INTESTINALES) POUR LUTTER CONTRE L'ANEMIE OU DES INFECTIONS PAR H. PYLORI (MONO ( IRON HYDROXYPYRONE ) AND COMBINATION ( IRON HYDROXYPYRONE AND GI INFLAMMATION INHIBITING AGENTS ) COMPOSITIONS FOR ANAEMIA OR H. PYLORI INFECTIONS)
United Kingdom	201419174

Ferric maltol Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Ferric Maltol

Introduction

Ferric maltol, marketed as Accrufer in the US and Feraccru in the EU, is a novel oral iron supplement designed to treat iron deficiency with or without anemia. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its growth, challenges, and future prospects.

Market Opportunity

Ferric maltol addresses a significant unmet need in the iron deficiency replacement therapy market. Traditional oral irons often lead to discontinuation due to intolerable gastrointestinal (GI) side effects or insufficient efficacy. Ferric maltol, with its improved tolerability and efficacy, presents a vast market opportunity. The total addressable market for oral iron replacement therapy is substantial, with over 6 million prescriptions in the US alone[1][3][5].

Regulatory Approvals

Ferric maltol has received approvals from major regulatory bodies, including the US FDA and the European Medicines Agency (EMA). This broad indication for use in adults with iron deficiency, with or without anemia, positions it as a leading treatment option in its class[4][5].

Commercial Performance

The commercial performance of ferric maltol has shown significant growth. In 2023, Shield Therapeutics reported a three-fold increase in total US Accrufer prescriptions compared to 2022, reaching 77,000 prescriptions. This growth was driven by a joint sales effort with Viatris, which included a 100-person dedicated sales team promoting Accrufer to over 12,000 healthcare professionals (HCPs)[3][5].

Quarterly Prescription Trends

The quarterly prescription trends for Accrufer have been positive, with a notable increase in prescriptions from Q1 2023 to Q2 2024. For instance, Q1 2024 saw 28,800 prescriptions, representing a 174% increase compared to Q1 2023[3][5].

Revenue Growth

The revenue from Accrufer sales has also seen substantial growth. In 2023, US net revenues for Accrufer reached $11.6 million, with the average net sales per prescription increasing from $119 in the first half of 2023 to $145 in the second half. This trend continued into 2024, with Q1 revenues of $4.0 million through 28,800 prescriptions[3][5].

Financial Highlights

Revenue and Other Income

For 2023, Shield Therapeutics reported total revenues and other income of $17.5 million, a significant increase from $6.2 million in 2022. This includes $11.6 million from Accrufer sales in the US, $1.5 million in ex-US royalty revenue, and $4.4 million from other income, including upfront payments from Viatris[3][5].

Cash Position and Funding

As of the end of 2023, Shield Therapeutics had $13.9 million in cash and cash equivalents. The company also completed a $6.1 million equity fundraising and secured a $20 million debt facility, which will provide sufficient resources to fund operations until projected cash flow breakeven in 2025[2][3].

Cost of Sales and Operating Loss

The cost of sales for Accrufer increased to $9.0 million in 2023, reflecting the higher volume of prescriptions. Despite the revenue growth, Shield Therapeutics reported an operating loss of $31.1 million for 2023, though this was an improvement from the $49.8 million loss in 2022[3].

Market Challenges

Pricing and Discounts

One of the challenges facing Accrufer is the impact of heavily discounted prescriptions, which has depressed the average net realized price per prescription. Despite this, the company has seen an upward trend in sales trajectory, particularly after the joint marketing operation with Viatris became effective in Q2 2023[2].

Geographic Variability

The growth of Accrufer prescriptions has shown variability across different regions. For example, while California and New York saw significant growth, Texas experienced a decline due to changes in Medicaid Pharmacy Benefit Manager (PBM) policies[3].

Global Expansion

Shield Therapeutics is actively expanding the global reach of ferric maltol. Key milestones include:

• Korea and Canada: Filing for approval in the second half of 2024 and awaiting Health Canada's decision in 2024, respectively[3][5].
• China: Approval expected by the end of 2026, with a milestone payment of $11.4 million upon approval[1][3].
• Pediatric Study: Completion of the pediatric study is expected in 2024, which could open up additional opportunities for treating patients under 18 years of age[3].

Future Prospects

Peak Revenue Potential

The peak revenue potential for Accrufer is estimated to be around $450 million, driven by its unique positioning in the market and the growing awareness among healthcare professionals[1].

Strategic Partnerships

The partnership with Viatris has been instrumental in the commercial expansion of Accrufer. The collaboration has enhanced the sales and marketing efforts, and both companies remain committed to making Accrufer the oral iron of choice in the US[3].

Path to Cash Flow Positive

Shield Therapeutics aims to turn cash flow positive in the second half of 2025. This goal is supported by the increasing prescription volumes, higher average net sales per prescription, and the new debt facility providing additional financial headroom[2][5].

Key Takeaways

• Market Opportunity: Ferric maltol addresses a significant need in the iron deficiency replacement therapy market due to its improved tolerability and efficacy.
• Commercial Performance: Significant growth in prescriptions and revenues, driven by a joint sales effort with Viatris.
• Financial Highlights: Total revenues and other income increased to $17.5 million in 2023, with a cash position of $13.9 million and additional funding secured.
• Global Expansion: Ongoing efforts to expand approval and availability in Korea, Canada, China, and potentially in pediatric patients.
• Future Prospects: Estimated peak revenue potential of $450 million and a goal to achieve cash flow positivity in the second half of 2025.

FAQs

What is ferric maltol, and how does it differ from traditional oral irons?

Ferric maltol is a novel oral iron supplement designed to treat iron deficiency with or without anemia. It differs from traditional oral irons by having improved tolerability and efficacy, with fewer gastrointestinal side effects.

Which regulatory bodies have approved ferric maltol?

Ferric maltol has been approved by the US FDA and the European Medicines Agency (EMA)[4][5].

What is the current market performance of Accrufer in the US?

Accrufer has seen significant growth, with 77,000 total US prescriptions in 2023, a three-fold increase from 2022. Q1 2024 saw 28,800 prescriptions, representing a 174% increase compared to Q1 2023[3][5].

What are the key financial highlights for Shield Therapeutics in 2023?

Total revenues and other income were $17.5 million, with $11.6 million from Accrufer sales in the US. The company had $13.9 million in cash and cash equivalents and secured additional funding through equity and debt facilities[3].

What are the future prospects for ferric maltol in terms of global expansion?

Shield Therapeutics is expanding ferric maltol's reach through approvals in Korea, Canada, and China, and is completing a pediatric study to potentially treat patients under 18 years of age[3][5].

When does Shield Therapeutics aim to achieve cash flow positivity?

Shield Therapeutics aims to turn cash flow positive in the second half of 2025, supported by increasing prescription volumes and additional financial resources[2][5].

Sources

1. Shield Therapeutics Corporate Presentation - August 2024
2. Proactive Investors: Shield Therapeutics: Accrufer progressing nicely, new finance put in place
3. Shield Therapeutics Annual Report and Accounts 2023
4. How Ferric Maltol gained so much acceptance worldwide?
5. Shield Therapeutics Corporate Presentation - April 2024