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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 and one FDA Regulatory Exclusivity.

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
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/002733 Feraccru 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
South Korea	20170071446	제2철 말톨의 결정질 형태 (2 CRYSTALLINE FORMS OF FERRIC MALTOL)
Singapore	11201702639R	CRYSTALLINE FORMS OF FERRIC MALTOL
South Korea	102351422
Japan	5769308
South Korea	102576930
Eurasian Patent Organization	033323	КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ЖЕЛЕЗНОЙ СОЛИ МАЛЬТОЛА (CRYSTALLINE FORMS OF FERRIC MALTOL)

ACCRUFER Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Accrufer

Introduction to Accrufer

Accrufer, also known as Feraccru, is a proprietary FDA-approved oral iron treatment developed by Shield Therapeutics. It is designed to address iron deficiency and iron deficiency anemia (IDA) with a broad label, making it a highly tolerable and effective solution compared to conventional iron treatments[2][3][4].

Market Opportunity and Growth Potential

Addressing Unmet Needs

Accrufer fills a significant unmet need in the iron deficiency market, particularly in the US where approximately 20 million individuals suffer from iron deficiency with or without anemia. This large and defined market presents a ripe opportunity for disruption and growth[2][3].

Regulatory Approvals and Expansion

Shield Therapeutics has made significant strides in expanding Accrufer's reach. The drug has been approved in the US since 2019, and the company is awaiting regulatory approval in Canada, expected in the first half of 2024. Additionally, a New Drug Application (NDA) is in progress in Korea[2][4].

Financial Performance and Revenue Growth

FY23 Financial Highlights

In the fiscal year 2023, Shield Therapeutics reported substantial growth in revenues and prescriptions for Accrufer. Total revenues and other income increased to $17.5 million, a 2.8x increase from FY22. Accrufer revenue specifically jumped to $11.6 million, a 3.1x increase from the previous year. Ex-US revenue was $1.5 million, and other income, including Viatris milestone payments, was $4.4 million[1][2].

Prescription Growth

The number of Accrufer prescriptions in FY23 was 77,000, adjusted from an initial figure of 90,500 due to a third-party data error. This still represents a 3.1x increase over FY22. The average net selling price per prescription in H2 2023 was $145, a 21% increase from H1 2023[1][2].

Strategic Partnerships and Sales Force Expansion

Viatris Partnership

A key factor in Accrufer's success is the collaborative sales agreement with Viatris Inc., formed in May 2023. This partnership has enabled Shield Therapeutics to target over 12,000 high-prescribing healthcare professionals in the US, significantly boosting prescription growth and revenue[1][4].

Sales Force Expansion

Shield Therapeutics has expanded its US sales force to 100 dedicated sales representatives, focusing on the highest prescribers of oral iron treatments. This strategic move has been instrumental in driving the growth of Accrufer prescriptions and revenues[3][4].

Cash Flow Management and Capital Structure

Cash Position and Financing

As of December 31, 2023, Shield Therapeutics had a cash balance of $13.9 million. The company has secured additional financing, including a $20 million term loan and equity financing of up to $7.4 million, to support its growth plans and aim for cash flow break-even by the end of 2024[1][5].

Cost Management and Efficiency

Shield Therapeutics is implementing measures to manage its cash flow effectively, including reductions in operating expenses and enhancements in working capital. These efforts are aimed at achieving cash flow positivity by H2 2025[1][5].

Key Performance Indicators (KPIs) and Growth Metrics

Revenue and Prescription Metrics

The company tracks key financial metrics such as US Accrufer revenue, net sales per prescription, and the number of prescriptions. These KPIs indicate strong growth, with Accrufer revenue and prescriptions tripling in FY23 compared to FY22[2][5].

Gross-to-Net Improvement

There was a notable improvement in the gross-to-net margin for Accrufer in FY23, with a 21% increase in the average net selling price per prescription in H2 2023 compared to H1 2023. This trend is expected to continue into FY24[1][2].

Future Outlook and Market Adoption

Expansion Plans

Shield Therapeutics is set to continue its aggressive expansion plans, including further penetration into the US market and expansion into new markets such as Canada and Korea. The company is also conducting studies to evaluate Accrufer's efficacy in children, which could open up additional market segments[3][4].

Regulatory and Clinical Milestones

The company is awaiting regulatory approval in Canada and expects to complete enrollment for a pediatric study in H1 2024, with results anticipated in H2 2024. These milestones are crucial for further market adoption and revenue growth[3][4].

Industry and Market Validation

Expert Opinions and Market Research

Recent market research has reaffirmed the unmet need in the target patient population for a well-tolerated and effective oral iron treatment. Healthcare professionals and patients continue to seek alternatives to conventional iron treatments, validating Accrufer's market position[1][2].

Competitive Advantage

Accrufer's broad FDA approval and its low side effect profile make it a potential best-in-class solution in the oral iron market. This competitive advantage, combined with the strong sales and marketing efforts, positions Accrufer for continued market dominance[2][3].

Challenges and Adjustments

Data Adjustments and Financial Reporting

Shield Therapeutics adjusted its total prescriptions figure for FY23 due to an error by a third-party data provider. However, this adjustment did not affect the financials, including revenues and compliance with financial covenants[1].

Key Takeaways

• Substantial Revenue Growth: Accrufer revenue tripled in FY23, reaching $11.6 million.
• Prescription Growth: Accrufer prescriptions increased by 3.1x in FY23, totaling 77,000.
• Strategic Partnerships: The partnership with Viatris has been instrumental in driving growth.
• Cash Flow Management: Shield Therapeutics is on track to achieve cash flow break-even by the end of 2024.
• Market Expansion: The company is expanding into new markets and conducting clinical studies to further validate Accrufer.

Frequently Asked Questions (FAQs)

1. What is Accrufer, and how does it differ from conventional iron treatments?

Accrufer is an FDA-approved oral iron treatment for iron deficiency and IDA, known for its high tolerability and low side effect profile, making it a preferred alternative to conventional iron treatments.

2. How has the partnership with Viatris impacted Accrufer's sales?

The partnership with Viatris has significantly boosted Accrufer's prescription growth and revenue by targeting over 12,000 high-prescribing healthcare professionals in the US.

3. What are the key financial metrics indicating Accrufer's growth?

Key metrics include a 3.1x increase in Accrufer revenue and prescriptions in FY23, a 21% increase in the average net selling price per prescription, and a strong cash balance to support future growth.

4. What are Shield Therapeutics' plans for expanding Accrufer's market reach?

Shield Therapeutics plans to expand into Canada and Korea, conduct pediatric studies, and further penetrate the US market to increase market adoption and revenue.

5. When does Shield Therapeutics expect to achieve cash flow break-even?

Shield Therapeutics aims to achieve cash flow break-even by the end of 2024, supported by its current financing and cost management strategies.

Cited Sources:

1. Vox Markets: Shield Therapeutics triples Accrufer revenues and prescriptions in FY23.
2. Shield Therapeutics: Financial statements for the year ended December 31, 2023.
3. Annual Reports: Shield Therapeutics plc Annual report and accounts 2022.
4. Marketscreener: Shield Therapeutics 2022 revenue jumps on Accrufer iron tablet sales.
5. Investegate: Interim results update and business update by Shield Therapeutics.