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Last Updated: December 23, 2024

IOTHALAMATE SODIUM I-125 - Generic Drug Details


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What are the generic drug sources for iothalamate sodium i-125 and what is the scope of patent protection?

Iothalamate sodium i-125 is the generic ingredient in one branded drug marketed by Isotex and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for IOTHALAMATE SODIUM I-125
Recent Clinical Trials for IOTHALAMATE SODIUM I-125

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

SponsorPhase
Mayo ClinicPhase 2
National Institutes of Health (NIH)Phase 1
National Heart, Lung, and Blood Institute (NHLBI)Phase 1

See all IOTHALAMATE SODIUM I-125 clinical trials

Pharmacology for IOTHALAMATE SODIUM I-125

US Patents and Regulatory Information for IOTHALAMATE SODIUM I-125

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Isotex GLOFIL-125 iothalamate sodium i-125 INJECTABLE;INJECTION 017279-001 Approved Prior to Jan 1, 1982 RX 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

IOTHALAMATE SODIUM I-125 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Iothalamate Sodium I-125

Introduction to Iothalamate Sodium I-125

Iothalamate sodium I-125 is a radiopharmaceutical used primarily for the evaluation of glomerular filtration rate (GFR) in patients with renal disease. It is a sterile, nonpyrogenic aqueous injection containing sodium iothalamate labeled with the radioactive isotope iodine-125 (I-125)[1].

Clinical Use and Mechanism

Diagnostic Purpose

Iothalamate sodium I-125 is indicated for assessing kidney function by measuring the glomerular filtration rate. Its clearance closely approximates that of inulin, a gold standard for GFR measurement, making it a reliable diagnostic tool[1][3].

Mechanism of Action

The compound is cleared by glomerular filtration without undergoing tubular secretion or reabsorption, which ensures accurate measurement of GFR. This characteristic makes it an essential tool in the diagnosis and monitoring of renal diseases[1].

Market Dynamics

Global Radiopharmaceuticals Market

The global radiopharmaceuticals market is projected to grow moderately, reaching $590 million by 2031, with a CAGR of 4.8%. This growth is driven by increasing preference for accurate diagnostic tests and targeted therapies, particularly in the fields of oncology and cardiology[5].

Segmental Growth

  • Diagnostic Segment: The diagnostics segment, which includes radiopharmaceuticals like iothalamate sodium I-125, currently leads the global market. This segment is expected to continue its dominance due to the rising demand for precise diagnostic tools[5].
  • Technological Advancements: Single-photon emission computed tomography (SPECT) technologies, which include the use of I-125, are among the highest revenue-generating segments. However, positron emission tomography (PET) is expected to show the fastest growth rate in the coming years[5].

End User Demand

  • Hospitals and Medical Centers: These institutions are the primary end users of radiopharmaceuticals, including iothalamate sodium I-125. The demand from these sectors is expected to remain high due to the ongoing need for accurate kidney function assessments[5].

Financial Trajectory

Market Size and Growth

The financial trajectory of iothalamate sodium I-125 is closely tied to the overall growth of the radiopharmaceuticals market. With the market expected to reach $590 million by 2031, the demand for diagnostic radiopharmaceuticals like iothalamate sodium I-125 is likely to increase, contributing to its financial growth[5].

Revenue Drivers

  • Increasing Diagnostic Needs: The rising incidence of renal diseases and the need for accurate diagnostic tools drive the demand for iothalamate sodium I-125. This increased demand translates into higher revenues for manufacturers.
  • Technological Integration: As SPECT and other diagnostic technologies continue to evolve, the integration of iothalamate sodium I-125 into these systems is expected to enhance its market value[5].

Competitive Landscape

The radiopharmaceuticals market is competitive, with various players offering different diagnostic and therapeutic agents. However, iothalamate sodium I-125 holds a unique position due to its specific use in kidney function assessment, which helps it maintain a stable market presence.

Regulatory and Safety Considerations

Approval and Use

Iothalamate sodium I-125 is approved for use in evaluating glomerular filtration in patients with renal disease. The regulatory framework supports its use, ensuring a stable market environment[1].

Safety Profile

The safety profile of iothalamate sodium I-125 is well-documented. It has a short biologic half-life of 1.5 hours, which minimizes the risk of prolonged exposure to radioactivity. This makes it a safe option for diagnostic purposes, especially when used according to the recommended dosages[2].

Future Outlook

Emerging Trends

  • Advancements in Diagnostic Technologies: The ongoing advancements in SPECT and PET technologies are expected to enhance the utility and accuracy of iothalamate sodium I-125, potentially increasing its market share.
  • Growing Awareness of Accurate Diagnostics: Increasing awareness among patients and healthcare providers about the importance of accurate diagnostics is likely to drive the demand for iothalamate sodium I-125 and other radiopharmaceuticals[5].

Challenges and Opportunities

  • Competition from Alternative Diagnostics: The emergence of new diagnostic tools and methods could pose a challenge to the market share of iothalamate sodium I-125. However, its established use and accuracy in measuring GFR provide a strong foundation for its continued relevance.
  • Expanding Applications: There may be opportunities to explore additional applications of iothalamate sodium I-125 beyond kidney function assessment, which could further boost its market potential.

Key Takeaways

  • Market Growth: The global radiopharmaceuticals market, including iothalamate sodium I-125, is expected to grow at a CAGR of 4.8% to reach $590 million by 2031.
  • Diagnostic Segment Dominance: The diagnostics segment, where iothalamate sodium I-125 is used, currently leads the market and is expected to continue its dominance.
  • Technological Advancements: Advancements in SPECT and PET technologies will enhance the utility and accuracy of iothalamate sodium I-125.
  • Safety and Regulatory Compliance: Iothalamate sodium I-125 has a well-documented safety profile and is approved for use in evaluating kidney function.

FAQs

What is iothalamate sodium I-125 used for?

Iothalamate sodium I-125 is used for the evaluation of glomerular filtration rate (GFR) in patients with renal disease.

How is iothalamate sodium I-125 administered?

It is administered via intravenous infusion or single intravenous injection.

What is the biologic half-life of iothalamate sodium I-125?

The biologic half-life of iothalamate sodium I-125 is approximately 1.5 hours with normal kidney function.

Is iothalamate sodium I-125 safe for breastfeeding mothers?

There is no specific information on the use of iothalamate sodium I-125 during breastfeeding. However, the drug is almost completely eliminated from the body within 8 hours, and mothers can safely resume breastfeeding once the radioactivity levels in their milk are at background levels[2].

What is the market outlook for iothalamate sodium I-125?

The market outlook is positive, with the global radiopharmaceuticals market expected to grow, driven by increasing demand for accurate diagnostic tools like iothalamate sodium I-125.

Sources

  1. Inxight Drugs: IOTHALAMATE SODIUM I-125 - Inxight Drugs.
  2. LactMed®: Iothalamate Sodium I 125 - Drugs and Lactation Database.
  3. The British Institute of Radiology: The Measurement of Glomerular Filtration Rate with 125I-iothalamate.
  4. Accessdata.fda.gov: 22580Orig1s000 - accessdata.fda.gov (Note: This source is not directly relevant but included for completeness).
  5. iHealthcareAnalyst: Global Radiopharmaceuticals Market $590 Million by 2031.

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