Market Dynamics and Financial Trajectory for Renografin-60
Introduction
Renografin-60, a radiopaque contrast agent composed of diatrizoate meglumine and diatrizoate sodium, has been a significant player in the medical imaging market. However, its market dynamics and financial trajectory have undergone significant changes, particularly with the discontinuation of the brand name in the U.S.
Product Overview
Renografin-60 is an ionic iodinated contrast medium used in various radiographic procedures, including intravenous urography, computed tomography (CT) scans, and other imaging techniques. It is supplied as a sterile, aqueous solution and contains 520 mg of diatrizoate meglumine and 80 mg of diatrizoate sodium per mL[1].
Market Positioning
Historically, Renografin-60 held a strong position in the market due to its efficacy in enhancing radiographic contrast. It was widely used for diagnosing and visualizing various body structures, including the kidneys, urinary passages, brain, and other body parts. However, the market has evolved with the introduction of newer, nonionic contrast agents that are generally considered safer and more comfortable for patients.
Discontinuation of Brand Name
The Renografin-60 brand name has been discontinued in the U.S., which has significantly impacted its market presence. Despite this, generic versions of the product may still be available, approved by the FDA, and these could continue to serve the market[1].
Competitive Landscape
The contrast agent market is highly competitive, with several other products available, including both ionic and nonionic agents. Nonionic agents, such as Isovue and Omnipaque, have gained popularity due to their lower osmolality and reduced risk of adverse reactions compared to ionic agents like Renografin-60[4].
Clinical Usage and Indications
Renografin-60 is indicated for various clinical applications, including CT scans of the brain and body, intravenous urography, and other radiographic procedures. Its use in detecting and evaluating lesions in the liver, pancreas, kidneys, and other areas has been well-documented. However, the shift towards nonionic agents has reduced its usage in some of these applications[1].
Dosage and Administration
The dosage of Renografin-60 varies depending on the procedure and patient population. For adults, the usual dose is 25 mL, while children require proportionately less. The agent must be at body temperature when injected and may need to be warmed before use[3].
Financial Impact of Discontinuation
The discontinuation of the Renografin-60 brand name has likely resulted in a significant decline in sales revenue for the product. Generic versions, while still available, may not command the same market price or brand loyalty as the original product. This shift has probably led to a reduction in the overall financial performance of Renografin-60.
Market Trends and Future Outlook
The market for contrast agents is driven by advancements in medical imaging technologies and the preference for safer, more effective agents. The trend towards nonionic contrast agents is expected to continue, further reducing the market share of ionic agents like Renografin-60. However, in regions where generic versions are still widely used, there may be some residual demand.
Regulatory Environment
The regulatory environment plays a crucial role in the market dynamics of pharmaceutical products. The FDA's approval and monitoring processes ensure that any generic versions of Renografin-60 meet the necessary safety and efficacy standards. This regulatory oversight helps maintain public trust in the product, even if the brand name is no longer available[1].
Pricing and Cost Considerations
The pricing of Renografin-60, particularly for generic versions, is influenced by market competition and regulatory factors. The cost of the product is generally lower than that of newer, nonionic agents, which can make it more attractive in cost-sensitive markets. However, the overall cost-effectiveness must be balanced against the potential for adverse reactions and the need for careful patient selection[5].
Key Takeaways
- Discontinuation Impact: The discontinuation of the Renografin-60 brand name has significantly reduced its market presence.
- Generic Availability: Generic versions of the product may still be available and approved by the FDA.
- Competitive Landscape: The market is dominated by nonionic contrast agents, which are considered safer and more comfortable.
- Clinical Usage: Renografin-60 is still indicated for various radiographic procedures but faces reduced usage due to the preference for nonionic agents.
- Financial Trajectory: The financial performance of Renografin-60 has likely declined with the discontinuation of the brand name.
FAQs
Q: What is Renografin-60 used for?
A: Renografin-60 is used as a radiopaque contrast agent for various radiographic procedures, including CT scans, intravenous urography, and other imaging techniques.
Q: Why was the Renografin-60 brand name discontinued?
A: The specific reasons for the discontinuation are not detailed, but it is common for pharmaceutical companies to discontinue brand names due to market competition, regulatory issues, or the availability of generic alternatives.
Q: Are generic versions of Renografin-60 still available?
A: Yes, generic versions of Renografin-60 may still be available and approved by the FDA.
Q: How does Renografin-60 compare to nonionic contrast agents?
A: Renografin-60 is an ionic agent, which generally has a higher osmolality and a greater risk of adverse reactions compared to nonionic agents.
Q: What is the typical dosage for Renografin-60?
A: The typical dosage for adults is 25 mL, while children require proportionately less, depending on the specific procedure and patient population[3].
Cited Sources
- Drugs.com - Renografin-60: Package Insert / Prescribing Information
- Stanford Profiles - Jayakar V. Nayak, MD, PhD (not directly relevant but included for completeness)
- Drugs.com - Renografin-60 Dosage Guide
- AJNR - Proton Relaxation Enhancement Associated with Iodinated Contrast Agents
- DrugBank - Diatrizoate: Uses, Interactions, Mechanism of Action