Ferric oxyhydroxide - Generic Drug Details

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

Ferric oxyhydroxide is the generic ingredient in eight branded drugs marketed by Am Regent, Sanofi Aventis Us, Allergan, New River, West-ward Pharms Int, and Vifor Fresenius, and is included in eight NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ferric oxyhydroxide has one hundred and twenty-nine patent family members in thirty-five countries.

There are three drug master file entries for ferric oxyhydroxide. Nine suppliers are listed for this compound.

Summary for ferric oxyhydroxide

International Patents:	129
US Patents:	11
Tradenames:	8
Applicants:	6
NDAs:	8
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	17
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ferric oxyhydroxide
DailyMed Link:	ferric oxyhydroxide at DailyMed

Pharmacology for ferric oxyhydroxide

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

US Patents and Regulatory Information for ferric oxyhydroxide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes
Am Regent	VENOFER	ferric oxyhydroxide	INJECTABLE;INTRAVENOUS	021135-004	Feb 9, 2007		RX	Yes	No
New River	PROFERDEX	ferric oxyhydroxide	INJECTABLE;INJECTION	017807-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes					Y
Sanofi Aventis Us	IRON DEXTRAN	ferric oxyhydroxide	INJECTABLE;INJECTION	010787-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Allergan	INFED	ferric oxyhydroxide	INJECTABLE;INJECTION	017441-001	Approved Prior to Jan 1, 1982	BP	RX	Yes	Yes
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes					Y

Expired US Patents for ferric oxyhydroxide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Am Regent	DEXFERRUM	ferric oxyhydroxide	INJECTABLE;INJECTION	040024-001	Feb 23, 1996
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013

International Patents for ferric oxyhydroxide

Country	Patent Number	Title	Estimated Expiration
Singapore	188789
Japan	2021138708
Israel	247741	תכשירי רוקחות המכילים ברזל אוקסו - הידרוקסיד, שיטות להכנתם והשימושים בהם (Pharmaceutical compositions comprising iron oxy-hydroxide, methods for the preparation thereof and their uses)
Croatia	P20240720
Taiwan	I592159
Cyprus	1123956
China	101861146	Pharmaceutical compositions

Ferric oxyhydroxide Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Ferric Oxyhydroxide

Introduction to Ferric Oxyhydroxide

Ferric oxyhydroxide, a compound with the chemical formula FeO(OH), is a versatile material used in various applications, including pharmaceuticals, water treatment, and industrial processes. This article delves into the market dynamics and financial trajectory of ferric oxyhydroxide, highlighting its current status, growth drivers, and future projections.

Market Size and Growth Projections

The global ferric hydroxide market, which includes ferric oxyhydroxide, is estimated to be significant and growing. As of 2024, the global ferric hydroxide market is valued at approximately $1.21 billion and is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.8% to reach $1.93 billion by 2034[3].

Key Market Growth Drivers

Several factors are driving the growth of the ferric oxyhydroxide market:

Pharmaceutical Applications

Ferric oxyhydroxide is used in pharmaceutical products, particularly in iron supplements and treatments for conditions like anemia. Its efficacy in treating serious infections and its role in products like Velphoro, which binds phosphate in patients with chronic kidney disease, contribute to its market growth[4][5].

Water Treatment

The use of granular ferric hydroxide in arsenic removal from drinking water is a significant driver. This method provides a chemical-free alternative for extracting high arsenic levels from groundwater, particularly in regions like the United States[3].

Industrial Applications

Ferric oxyhydroxide is utilized in various industrial applications, including as a colorant for ceramics, paper, rubber, plastics, glass, textiles, and as a component in fertilizers and industrial chemicals. These diverse applications ensure a steady demand for the compound[3].

Regional Market Analysis

United States

The U.S. market for ferric hydroxide is substantial, driven by the extensive use of granular ferric hydroxide in arsenic removal from drinking water. The market value in the U.S. is expected to grow from $154.2 million in 2024 to $265.4 million by 2034 at a CAGR of 5.6%[3].

China

China is another key market, with the ferric hydroxide market driven by government policies promoting cleaner energy sources, reducing supply chain disruptions, and a focus on cost consciousness and operational efficiency. The market value in China is projected to grow from $181.4 million in 2024 to $318.6 million by 2034 at a CAGR of 5.8%[3].

Product Forms and Applications

Product Forms

Ferric hydroxide is available in various forms, with the slurry segment holding a significant market share due to its ease of handling. The slurry segment is expected to account for 64.2% of the market in 2024, growing at a CAGR of 4.5% from 2024 to 2034[3].

Applications

The applications of ferric oxyhydroxide are diverse, including:

• Lithium Iron Phosphate Battery: Used as a component in battery production.
• Magnetic Material: Utilized in the manufacture of magnetic materials.
• Pigment: Used as a colorant in various industries.
• Catalyzer: Employed in chemical reactions.
• Others: Includes applications in fertilizers, cosmetics, and industrial chemicals[2].

Competitive Landscape

The ferric oxyhydroxide market is competitive, with several key players:

• Lanxess
• Ferro Corporation
• BASF SE
• Harold Scholz & Co. GmbH
• SIOF S.p.a.
• Jinhe Enterprise Co. Limited
• Yipin Pigments
• Nemysis Ltd.
• Kolinpharma SpA
• Cathay Industries
• **Jiangsu Yuxing Industry and Trade Co. Ltd.[3].

Regulatory Considerations

The FDA's interpretation of the definition of a New Chemical Entity (NCE) is crucial for ferric oxyhydroxide products. The FDA has denied NCE exclusivity for products like Velphoro, stating that ferric oxyhydroxide is not a novel active moiety since it has been previously approved in other forms[5].

Financial Trajectory

The financial trajectory of the ferric oxyhydroxide market is positive, driven by increasing demand across various sectors. Here are some key financial projections:

• Global Market Value: Expected to grow from $1.21 billion in 2024 to $1.93 billion by 2034 at a CAGR of 4.8%[3].
• Regional Growth: Significant growth is anticipated in the U.S. and China, with CAGRs of 5.6% and 5.8%, respectively[3].

Challenges and Opportunities

Challenges

• Regulatory Hurdles: The FDA's strict interpretation of NCE exclusivity can impact new product developments.
• Competition: The market is highly competitive, with multiple players vying for market share.

Opportunities

• Expanding Applications: New applications in industries such as lithium-ion batteries and magnetic materials offer growth opportunities.
• Government Policies: Supportive government policies in regions like China can drive market growth.

Key Takeaways

• The global ferric hydroxide market, including ferric oxyhydroxide, is expected to grow significantly from 2024 to 2034.
• Key drivers include pharmaceutical applications, water treatment, and industrial uses.
• The U.S. and China are significant markets, driven by specific regional factors.
• The competitive landscape is diverse, with several major players.
• Regulatory considerations, particularly FDA interpretations, are crucial for market dynamics.

Frequently Asked Questions (FAQs)

Q: What is the current market size of the global ferric hydroxide market? A: The global ferric hydroxide market was valued at approximately $1.21 billion in 2024[3].

Q: What is the projected CAGR for the global ferric hydroxide market from 2024 to 2034? A: The market is expected to grow at a CAGR of 4.8% from 2024 to 2034[3].

Q: Which regions are expected to drive the growth of the ferric oxyhydroxide market? A: The U.S. and China are expected to be key drivers of market growth due to specific regional factors[3].

Q: What are the primary applications of ferric oxyhydroxide? A: Primary applications include pharmaceuticals, water treatment, lithium-ion batteries, magnetic materials, pigments, and catalyzers[2][3].

Q: Who are the major players in the ferric oxyhydroxide market? A: Major players include Lanxess, Ferro Corporation, BASF SE, Harold Scholz & Co. GmbH, and others[3].

Sources Cited

1. Grandview Research: Intravenous Iron Drugs Market Size And Share Report, 2030
2. Valuates Reports: Global Ferric Oxyhydroxide Market Research Report 2024
3. Fact.MR: Ferric Hydroxide Market Size & Share | Industry Growth By 2034
4. Regulations.gov: Docket No. FDA-2016-P-1163 - Regulations.gov
5. Hogan Lovells: FDA denial of Vifor Velphoro petition shines new light on NCE interpretation