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Last Updated: January 3, 2025

VENOFER Drug Patent Profile


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Which patents cover Venofer, and what generic alternatives are available?

Venofer is a drug marketed by Am Regent and is included in one NDA.

The generic ingredient in VENOFER is ferric oxyhydroxide. There are twenty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ferric oxyhydroxide profile page.

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Summary for VENOFER
Drug patent expirations by year for VENOFER
Drug Prices for VENOFER

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Recent Clinical Trials for VENOFER

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

SponsorPhase
Western Galilee Hospital-NahariyaPhase 4
Fox Chase Cancer CenterPhase 2
Medical Center HaaglandenN/A

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Pharmacology for VENOFER

US Patents and Regulatory Information for VENOFER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Am Regent VENOFER ferric oxyhydroxide INJECTABLE;INTRAVENOUS 021135-002 Mar 20, 2005 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Am Regent VENOFER ferric oxyhydroxide INJECTABLE;INTRAVENOUS 021135-001 Nov 6, 2000 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Am Regent VENOFER ferric oxyhydroxide INJECTABLE;INTRAVENOUS 021135-005 Mar 29, 2013 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Am Regent VENOFER ferric oxyhydroxide INJECTABLE;INTRAVENOUS 021135-003 Mar 29, 2005 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Am Regent VENOFER ferric oxyhydroxide INJECTABLE;INTRAVENOUS 021135-004 Feb 9, 2007 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

VENOFER Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Venofer (Iron Sucrose Injection)

Market Overview

The global market for intravenous iron drugs, which includes Venofer (Iron Sucrose Injection), is experiencing significant growth driven by several key factors. Here’s a detailed look at the market dynamics and financial trajectory of Venofer.

Global Intravenous Iron Drugs Market

The global intravenous iron drugs market, of which Venofer is a part, was valued at USD 2.95 billion in 2022 and is projected to grow to USD 6.10 billion by 2031, with a CAGR of 8.4% from 2024 to 2031[3].

Segmentation and Market Share

By Type

The market is segmented into various types, including Iron Dextran, Iron Sucrose (Venofer), Ferric Carboxymaltose, and others. Ferric Carboxymaltose holds the largest market share, but Iron Sucrose remains a significant segment due to its efficacy and safety profile[3].

By Application

Venofer is primarily used in the treatment of iron deficiency anemia (IDA) and chronic kidney disease (CKD). The CKD segment accounts for a substantial revenue share, with 35% of the market in 2023, highlighting the critical role of Venofer in nephrology[1][3].

Regional Performance

North America

North America dominates the intravenous iron drugs market, capturing a significant market share. This is largely due to the increasing approvals and launches of new IV iron drugs in the United States. For instance, the FDA's approval of Injectafer (a competitor to Venofer) for pediatric patients has bolstered the market position in this region[3].

Asia Pacific

The Asia Pacific region is expected to experience the fastest growth during the forecast period, driven by geographic expansion, government initiatives, and a high incidence of iron deficiency anemia[1][3].

Key Drivers

Increasing Prevalence of Iron Deficiency Anemia

The rising prevalence of ID and IDA globally is a major driver for the market. Chronic diseases such as CKD, heart failure, and gastrointestinal disorders contribute to this increase, making Venofer a crucial treatment option[4].

Regulatory Approvals and Product Launches

New product launches and regulatory approvals are critical for market expansion. For example, the FDA’s approval of drugs like Injectafer has been pivotal in driving market growth, and similar approvals for Venofer can significantly impact its market share[1].

Demand for Dextran-Free Iron Therapeutics

The growing demand for dextran-free iron therapeutics, such as Venofer, is another key driver. This demand is driven by the need for safer and more effective treatment options[4].

Financial Performance

Market Size and Growth

The Venofer Iron Sucrose Injection Sales Market is anticipated to witness substantial growth from 2023 to 2031. While exact figures for Venofer alone are not provided, the overall intravenous iron drugs market is expected to grow significantly, with Venofer being a key player in this segment[5].

Revenue Contribution

Venofer, along with other IV iron drugs, contributes significantly to the revenue of pharmaceutical companies. For instance, Vifor Pharma, which markets Venofer, reported strong financial performance in 2018, with net sales of CHF 1,584.6 million and EBITDA of CHF 391.5 million. The company's IV iron products, including Ferinject/Injectafer and Venofer, were major contributors to this growth[2].

Competitive Landscape

The market for intravenous iron drugs is highly competitive, with key players such as CSL Vifor, Daiichi Sankyo, Covis Pharmaceuticals, Akebia Therapeutics, and Shield Therapeutics. These companies focus on research and development, strategic collaborations, and regulatory approvals to maintain their market position[4].

Distribution and Accessibility

Hospital Pharmacies

Hospital pharmacies play a crucial role in the distribution of Venofer, offering it with adequate discounts and rebates, making it a cost-effective option for patients and healthcare systems[4].

Challenges and Opportunities

Adverse Reactions

One of the notable restraints in the market is the risk of adverse reactions associated with IV iron drugs. However, Venofer is known for its safety profile, which can be a competitive advantage[3].

Innovative Formulations

The development of innovative iron formulations that offer improved safety and convenience presents opportunities for growth. Companies like Vifor Pharma are continuously working on new generations of IV and oral iron drugs with broader indications and improved treatment outcomes[4].

Key Takeaways

  • The global intravenous iron drugs market, including Venofer, is expected to grow significantly, driven by the increasing prevalence of ID and IDA.
  • North America and the Asia Pacific region are key markets, with North America currently holding the largest market share.
  • Regulatory approvals and new product launches are critical for market expansion.
  • The demand for dextran-free iron therapeutics is a significant driver for Venofer.
  • Hospital pharmacies play a crucial role in the distribution and accessibility of Venofer.

FAQs

1. What is the projected growth rate of the global intravenous iron drugs market?

The global intravenous iron drugs market is expected to grow at a CAGR of 8.4% from 2024 to 2031[3].

2. Which segment accounts for the largest market share in the intravenous iron drugs market?

The Ferric Carboxymaltose segment accounts for the largest market share, but Iron Sucrose (Venofer) remains a significant segment[1][3].

3. What are the primary applications of Venofer?

Venofer is primarily used in the treatment of iron deficiency anemia (IDA) and chronic kidney disease (CKD)[1][3].

4. Which region is expected to experience the fastest growth in the intravenous iron drugs market?

The Asia Pacific region is expected to experience the fastest growth during the forecast period[1][3].

5. What are the key drivers for the growth of the Venofer market?

Key drivers include the increasing prevalence of ID and IDA, demand for dextran-free iron therapeutics, and regulatory approvals and product launches[1][4].

Cited Sources:

  1. Precedence Research, "Intravenous Iron Drugs Market Size to Worth Around US$ 7.41 Billion by 2033", Biospace, July 12, 2024.
  2. Vifor Pharma Group, "Annual Report 2018", Annual Reports, March 14, 2019.
  3. Skyquestt, "Intravenous Iron Drugs Market Size, Share, Trends & Forecast | 2031", Skyquestt, March 2024.
  4. GlobeNewswire, "Global IV & Oral Iron Drugs Market Report 2024: Focused Insights for 2023-2029", GlobeNewswire, February 9, 2024.
  5. Market Research Intellect, "Global Venofer (Iron Sucrose Injection) Sales Market Size, Scope, Forecast 2023-2031", Market Research Intellect, October 2024.

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