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Last Updated: January 4, 2025

PROFERDEX Drug Patent Profile


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Which patents cover Proferdex, and when can generic versions of Proferdex launch?

Proferdex is a drug marketed by New River and is included in one NDA.

The generic ingredient in PROFERDEX 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 PROFERDEX
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 33
DailyMed Link:PROFERDEX at DailyMed
Drug patent expirations by year for PROFERDEX

US Patents and Regulatory Information for PROFERDEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
New River PROFERDEX ferric oxyhydroxide INJECTABLE;INJECTION 017807-001 Approved Prior to Jan 1, 1982 DISCN No 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

PROFERDEX Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Proferdex

Introduction

Proferdex, also known as iron dextran, is an intravenous iron drug used to treat severe iron deficiency. To understand its market dynamics and financial trajectory, it is essential to delve into the broader context of the intravenous iron drugs market and the factors influencing its growth.

Global Intravenous Iron Drugs Market Overview

The global intravenous iron drugs market is a significant segment within the pharmaceutical industry. As of 2023, this market was estimated at USD 3.03 billion and is expected to expand at a CAGR of 9.2% from 2024 to 2030[4].

Product Outlook: Iron Dextran

Iron dextran, marketed under names such as Proferdex, Dexferrum, and InFeD, is one of the key products in this market. It is administered intravenously to treat severe iron-deficiency anemia, particularly in patients who cannot tolerate oral iron supplements or have chronic conditions such as chronic kidney disease, inflammatory bowel disease, and cancer[5].

Market Drivers

Several factors drive the growth of the intravenous iron drugs market, including:

Increasing Prevalence of Chronic Diseases

Chronic diseases such as chronic kidney disease, inflammatory bowel disease, and cancer are on the rise, leading to an increased demand for intravenous iron therapies. These conditions often result in iron deficiency anemia, making intravenous iron drugs like Proferdex essential for patient treatment[4].

Advancements in Formulation Technologies

Innovations in formulation technologies have improved the efficacy and safety of intravenous iron drugs. For instance, newer formulations like ferric carboxymaltose offer better tolerability and fewer adverse reactions, which can further boost the market for traditional products like iron dextran[4].

Growing Focus on Patient Convenience

There is a growing emphasis on patient convenience and adherence to treatment. Intravenous iron drugs, especially those with simpler administration protocols, are gaining preference. This trend is expected to continue, driving the demand for products like Proferdex[1].

Regional Market Analysis

The intravenous iron drugs market is geographically diverse, with significant contributions from various regions:

North America

North America, particularly the U.S. and Canada, is a major market for intravenous iron drugs. The region's advanced healthcare infrastructure and high prevalence of chronic diseases contribute to its substantial market share[4].

Europe

Europe is another significant market, with countries like the UK, Germany, France, and Italy showing considerable demand for intravenous iron therapies[4].

Asia Pacific

The Asia Pacific region, including countries like Japan, China, and India, is expected to grow rapidly due to increasing healthcare spending and a rising prevalence of chronic diseases[4].

Financial Trajectory

The financial trajectory of Proferdex and similar intravenous iron drugs is closely tied to the overall growth of the market.

Revenue Growth

Given the projected CAGR of 9.2% for the intravenous iron drugs market from 2024 to 2030, it is reasonable to expect that products like Proferdex will see significant revenue growth. This growth will be driven by increasing demand, advancements in technology, and expanding market reach[4].

Competitive Landscape

The market for intravenous iron drugs is competitive, with several key players offering different formulations. Proferdex competes with other iron-based products such as iron sucrose (Venofer) and ferric carboxymaltose. The competitive landscape is expected to remain dynamic, with companies focusing on innovation and market expansion to gain a competitive edge[4].

Challenges and Opportunities

While the market for Proferdex and other intravenous iron drugs is promising, there are challenges and opportunities to consider:

Regulatory Compliance

Companies must comply with stringent regulatory requirements, which can sometimes delay product approvals and affect market dynamics. For instance, any issues with manufacturing facilities, as seen in Form 483 inspections, can impact product availability and reputation[2].

Innovation and R&D

Investments in research and development are crucial for maintaining market position. Companies need to focus on improving formulations, reducing side effects, and enhancing patient convenience to stay competitive. This is particularly important as the market shifts towards more personalized and efficient treatments[3].

Key Takeaways

  • The global intravenous iron drugs market is expected to grow at a CAGR of 9.2% from 2024 to 2030.
  • Iron dextran (Proferdex) is a significant product in this market, driven by the increasing prevalence of chronic diseases.
  • Advancements in formulation technologies and a focus on patient convenience are key market drivers.
  • The market is geographically diverse, with North America, Europe, and the Asia Pacific being major contributors.
  • Regulatory compliance and continuous innovation are critical for maintaining market position.

FAQs

  1. What is Proferdex used for? Proferdex, or iron dextran, is used to treat severe iron-deficiency anemia, particularly in patients who cannot tolerate oral iron supplements or have chronic conditions such as chronic kidney disease, inflammatory bowel disease, and cancer[5].

  2. What is the projected growth rate of the intravenous iron drugs market? The intravenous iron drugs market is expected to expand at a CAGR of 9.2% from 2024 to 2030[4].

  3. Which regions are significant contributors to the intravenous iron drugs market? North America, Europe, and the Asia Pacific are major contributors to the intravenous iron drugs market[4].

  4. What are the key drivers of the intravenous iron drugs market? The key drivers include the increasing prevalence of chronic diseases, advancements in formulation technologies, and a growing focus on patient convenience[4].

  5. How does regulatory compliance impact the market for Proferdex? Regulatory compliance is crucial as any issues with manufacturing facilities can impact product availability and reputation. Companies must adhere to stringent regulatory requirements to maintain market position[2].

Sources

  1. Grand View Research - Injectable Drug Delivery Devices Market Size Report, 2030
  2. FDA - Form 483 issued to Sun Pharma
  3. Carlson School of Management - R&D Investment Following the Erosion of Existing Products
  4. Grand View Research - Intravenous Iron Drugs Market Size And Share Report, 2030
  5. ACS Publications - Metallodrugs in Medicinal Inorganic Chemistry

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