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Last Updated: December 22, 2024

IDOXURIDINE - Generic Drug Details


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What are the generic drug sources for idoxuridine and what is the scope of freedom to operate?

Idoxuridine is the generic ingredient in three branded drugs marketed by Glaxosmithkline, Alcon, and Allergan, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for idoxuridine.

Summary for IDOXURIDINE
Recent Clinical Trials for IDOXURIDINE

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

SponsorPhase
National Cancer Institute (NCI)Phase 2
Rush University Medical CenterPhase 2

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Medical Subject Heading (MeSH) Categories for IDOXURIDINE

US Patents and Regulatory Information for IDOXURIDINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline STOXIL idoxuridine SOLUTION/DROPS;OPHTHALMIC 013934-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glaxosmithkline STOXIL idoxuridine OINTMENT;OPHTHALMIC 015868-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Allergan HERPLEX idoxuridine SOLUTION/DROPS;OPHTHALMIC 013935-002 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

IDOXURIDINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Idoxuridine

Introduction

Idoxuridine, an antiviral drug, has been in use for several decades, primarily for the treatment of herpes simplex virus infections, particularly in the form of keratoconjunctivitis and keratitis. To understand the market dynamics and financial trajectory of idoxuridine, it is crucial to delve into its usage, market trends, and the financial health of companies involved in its production and distribution.

Historical Use and Mechanism of Action

Idoxuridine acts by inhibiting viral replication by substituting itself for thymidine in viral DNA, thereby preventing the virus from reproducing and infecting or destroying tissue[4].

Market Size and Growth

The market for antiviral drugs, including idoxuridine, is influenced by several factors such as the prevalence of viral infections, advancements in medical technology, and regulatory approvals.

Prevalence of Viral Infections

The demand for antiviral drugs like idoxuridine is driven by the prevalence of herpes simplex virus infections. Given that these infections are common and recurring, there is a steady demand for effective treatments.

Technological Advancements

While idoxuridine itself is not a new drug, advancements in drug delivery systems and formulations can impact its market. For instance, sustained-release formulations and innovative delivery methods can enhance patient compliance and efficacy, potentially boosting market growth.

Regulatory Environment

Regulatory approvals and guidelines play a critical role in the market dynamics of pharmaceuticals. For idoxuridine, its approval and continued use are contingent on its safety and efficacy profile, which must be maintained through ongoing clinical trials and post-marketing surveillance.

Financial Health of Manufacturers

Companies involved in the production and distribution of idoxuridine, such as GlaxoSmithKline, Alcon Laboratories Inc., and Allergan Pharmaceuticals, have diverse financial profiles.

Revenue and Expenses

The revenue generated from idoxuridine is typically modest compared to blockbuster drugs. However, it contributes to the overall portfolio of these pharmaceutical companies. The expenses associated with producing and marketing idoxuridine are relatively stable, given its established status in the market.

Financial Ratios and Performance

For companies like those mentioned, the financial performance is often evaluated through various ratios such as the price-to-book ratio, current ratio, and EBIT margin. While idoxuridine may not be a high-revenue generator, it helps in maintaining a balanced product portfolio.

Emerging Trends and Challenges

Emerging Markets

The growth of emerging markets presents opportunities for increased sales of idoxuridine. Strategic collaborations, as seen with companies like Shuttle Pharmaceuticals Holdings Inc., can bolster market presence in these regions[3].

Technological Innovations

Technological advancements in drug development, such as those in sustained-release formulations and novel delivery systems, can enhance the market position of idoxuridine. However, these innovations also come with significant investment costs.

Regulatory and Economic Challenges

Regulatory changes, economic fluctuations, and global events like the COVID-19 pandemic can impact the market dynamics of idoxuridine. For instance, high inflation and geopolitical conflicts can affect production costs and supply chains[1].

Case Study: Shuttle Pharmaceuticals Holdings Inc.

While Shuttle Pharmaceuticals Holdings Inc. is not primarily known for idoxuridine, its approach to innovation and clinical trials can provide insights into the broader pharmaceutical market.

Clinical Trials and Innovations

Shuttle Pharmaceuticals' focus on clinical trials, such as those for Ropidoxuridine, a potential treatment for glioblastoma, highlights the importance of innovation in driving market growth. Although these trials are not directly related to idoxuridine, they demonstrate the company's commitment to medical innovation, which can have indirect benefits for other products in their portfolio[3].

Financial Health

Shuttle Pharmaceuticals' financial health is characterized by significant investments in clinical trials and innovations, leading to operating losses but also potential for future growth. This scenario is reflective of the risks and rewards associated with pharmaceutical research and development.

Market Segmentation

The market for idoxuridine can be segmented by type, product type, and disease condition.

By Type

  • Hospital Prescription Drugs: Idoxuridine is often prescribed in a hospital setting for severe cases of viral infections.
  • Over The Counter Drugs: While less common, some formulations of idoxuridine may be available over the counter for mild infections[1].

By Product Type

  • Topical Solutions: The most common form of idoxuridine is topical solutions applied directly to the affected area.
  • Ointments and Creams: Other forms include ointments and creams, which may offer different delivery mechanisms and patient compliance benefits[4].

By Disease Condition

  • Herpes Simplex Virus Keratitis: Idoxuridine is primarily used for treating keratitis caused by the herpes simplex virus.
  • Keratoconjunctivitis: It is also used for treating keratoconjunctivitis, another condition caused by the herpes simplex virus[4].

Regional Market Analysis

The market for idoxuridine varies by region, influenced by factors such as disease prevalence, healthcare infrastructure, and regulatory environments.

North America

North America is a significant market for idoxuridine, with well-established healthcare systems and a high awareness of antiviral treatments[1].

Emerging Markets

Emerging markets, particularly in the Middle East and Asia-Pacific, are expected to grow rapidly due to increasing healthcare expenditure and disease awareness campaigns[1].

Key Takeaways

  • Stable Demand: Idoxuridine has a stable demand driven by the prevalence of herpes simplex virus infections.
  • Technological Advancements: Innovations in drug delivery systems can enhance market growth.
  • Regulatory Environment: Regulatory approvals and guidelines are crucial for the continued use of idoxuridine.
  • Financial Health: Manufacturers' financial health is influenced by their overall product portfolio and investment in innovations.
  • Regional Variations: Market dynamics vary by region, with emerging markets showing significant growth potential.

FAQs

What is the primary use of idoxuridine?

Idoxuridine is primarily used for the treatment of keratoconjunctivitis and keratitis caused by the herpes simplex virus.

How does idoxuridine work?

Idoxuridine acts as an antiviral agent by inhibiting viral replication by substituting itself for thymidine in viral DNA, thereby preventing the virus from reproducing and infecting or destroying tissue[4].

Which companies are involved in the production of idoxuridine?

Companies such as GlaxoSmithKline, Alcon Laboratories Inc., and Allergan Pharmaceuticals are involved in the production and distribution of idoxuridine[4].

What are the emerging trends in the market for idoxuridine?

Emerging trends include technological advancements in drug delivery systems, strategic collaborations in emerging markets, and the impact of regulatory and economic challenges[1][3].

How does the financial health of manufacturers impact the market for idoxuridine?

The financial health of manufacturers, including their investment in innovations and their overall product portfolio, influences the market dynamics of idoxuridine. Significant investments in clinical trials and innovations can lead to potential future growth despite current operating losses[3].

Sources

  1. The Business Research Company. Global Antiglaucoma Drugs Market Report 2024.
  2. ABS Biotrade. Fairness, Equity and Efficiency for the Convention on Biological Diversity and the Nagoya Protocol.
  3. Timothy Sykes. Is Shuttle Pharmaceuticals Holdings Inc. Poised for Growth After Recent Milestones?
  4. DrugBank. Idoxuridine: Uses, Interactions, Mechanism of Action.

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