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Last Updated: December 23, 2024

IOTHALAMATE SODIUM - Generic Drug Details


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

Iothalamate sodium is the generic ingredient in four branded drugs marketed by Mallinckrodt and Isotex, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Summary for IOTHALAMATE SODIUM
US Patents:0
Tradenames:4
Applicants:2
NDAs:4
Raw Ingredient (Bulk) Api Vendors: 19
Clinical Trials: 6
Patent Applications: 996
DailyMed Link:IOTHALAMATE SODIUM at DailyMed
Recent Clinical Trials for IOTHALAMATE SODIUM

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 clinical trials

US Patents and Regulatory Information for IOTHALAMATE SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt CONRAY 325 iothalamate sodium INJECTABLE;INJECTION 017685-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mallinckrodt CONRAY 400 iothalamate sodium INJECTABLE;INJECTION 014295-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mallinckrodt ANGIO-CONRAY iothalamate sodium INJECTABLE;INJECTION 013319-001 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

IOTHALAMATE SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Iothalamate Sodium

Introduction

Iothalamate sodium, particularly when labeled with radioactive iodine (e.g., I-125), is a significant compound in medical diagnostics, especially in the assessment of renal function. Here, we will delve into the market dynamics and financial trajectory of iothalamate sodium, highlighting its applications, market growth, and future projections.

Applications of Iothalamate Sodium

Iothalamate sodium is widely used as a radiopharmaceutical, particularly for measuring glomerular filtration rate (GFR), which is crucial for assessing kidney function.

Diagnostic Imaging

Iothalamate sodium I-125 is used in single intravenous injection studies to estimate GFR. It has been shown to be a reliable glomerular marker, comparable to inulin clearance, which is the gold standard for measuring GFR[2][5].

Clinical Use

The compound is favored for its accuracy and the ease of administration. It requires less frequent blood sampling compared to other methods, although it still necessitates external counting over a period to ensure reliable estimates[2].

Market Growth and Projections

While iothalamate sodium is a niche product within the broader sodium iodide market, its specific applications contribute significantly to the overall market dynamics.

Sodium Iodide Market Overview

The global sodium iodide market, which includes iothalamate sodium, is projected to grow at a moderate CAGR of 5.8% from 2024 to 2034. This growth is driven by various factors including increased demand from the healthcare sector, particularly for diagnostic imaging procedures[1].

Regional Demand

Countries like Japan and India are expected to exhibit high demand for sodium iodide, including iothalamate sodium, with CAGRs of 6.9% and 7.1%, respectively, through 2034. The United States, with a well-established healthcare industry, will also see significant growth, albeit at a lower CAGR of 3.9%[1].

Financial Trajectory

The financial trajectory of iothalamate sodium is closely tied to the broader sodium iodide market.

Market Value

The global sodium iodide market is estimated to reach USD 173 million by 2024 and is projected to expand to USD 304 million by 2034. This substantial growth indicates a robust financial outlook for compounds like iothalamate sodium[1].

Healthcare Expenditure

Increasing healthcare expenditure and the adoption of iodine-based medical procedures are key drivers of the market growth. As healthcare spending continues to rise, the demand for diagnostic tools like iothalamate sodium is expected to increase, contributing to the financial trajectory of the market[1].

Technological Advancements

Technological advancements in manufacturing and medical imaging are enhancing the appeal of sodium iodide, including iothalamate sodium, to end-users.

Digital Technologies and IoT

The integration of digital technologies and IoT devices in manufacturing processes has improved real-time monitoring, predictive maintenance, and quality assurance. These advancements are likely to make the production of iothalamate sodium more efficient and cost-effective[1].

Regulatory Environment

The regulatory environment plays a crucial role in shaping the market dynamics of iothalamate sodium.

Compliance and Innovation

Government regulations on food fortification and medical diagnostics influence product innovation and compliance efforts. For iothalamate sodium, adherence to strict medical standards and regulatory approvals are essential for market growth[1].

Consumer Preferences

Consumer preferences, particularly in the healthcare sector, are shifting towards clean label products and natural sources of iodine.

Clean Label Trends

Manufacturers are exploring natural sources of iodine and clean label alternatives to meet consumer demand for transparency and authenticity. This trend may influence the formulation and marketing strategies for iothalamate sodium, although its primary use is in medical diagnostics rather than consumer products[1].

Health and Wellness Trends

Health and wellness trends are driving the demand for iodine supplements and, by extension, compounds like iothalamate sodium.

Iodine Supplementation

The focus on health and wellness is fueling the demand for iodine-based products, including those used in veterinary practice. While iothalamate sodium is primarily used in human diagnostics, the broader trend of iodine supplementation supports the overall market growth[1].

Globalization and Market Expansion

Globalization and market expansion are expected to result in broader geographic reach and market penetration for sodium iodide, including iothalamate sodium.

Geographic Reach

The market for sodium iodide is expanding globally, with significant growth anticipated in regions like Asia-Pacific. This expansion will likely increase the availability and demand for iothalamate sodium in various countries[1].

Key Takeaways

  • Market Growth: The global sodium iodide market, which includes iothalamate sodium, is projected to grow at a CAGR of 5.8% from 2024 to 2034.
  • Regional Demand: High demand is expected in countries like Japan and India, with significant growth also anticipated in the United States.
  • Technological Advancements: Digital technologies and IoT devices are improving manufacturing efficiency and quality assurance.
  • Regulatory Environment: Adherence to regulatory standards is crucial for market growth and product innovation.
  • Consumer Preferences: Trends towards clean label products and natural sources of iodine may influence product formulation and marketing.

FAQs

Q: What is the primary use of iothalamate sodium in medical diagnostics? A: Iothalamate sodium, particularly when labeled with I-125, is used to measure glomerular filtration rate (GFR) in assessing kidney function.

Q: How does the global sodium iodide market impact the demand for iothalamate sodium? A: The growing demand for sodium iodide, driven by healthcare and food industries, directly influences the demand for iothalamate sodium, as it is a part of this broader market.

Q: What are the key drivers of the market growth for iothalamate sodium? A: Key drivers include increasing healthcare expenditure, technological advancements, and regulatory support for iodine-based medical procedures.

Q: How do consumer preferences affect the market for iothalamate sodium? A: While consumer preferences for clean label products primarily affect consumer goods, they can influence the broader trend towards natural and transparent products, indirectly supporting the demand for iodine-based compounds.

Q: What are the regional growth projections for the sodium iodide market, including iothalamate sodium? A: Countries like Japan and India are expected to exhibit high demand, with CAGRs of 6.9% and 7.1%, respectively, through 2034, while the United States will see growth at a CAGR of 3.9%[1].

Sources

  1. Future Market Insights - Sodium Iodide Market Share, Trends & Forecast by 2034
  2. PubMed - The usefulness of 125I-sodium iothalamate as a GFR-indicator in ...
  3. FDA - 22580Orig1s000 MEDICAL REVIEW(S) CLINICAL REVIEW
  4. PubChem - Iothalamate Sodium I-125
  5. JAMA Network - Renal Clearance in Man of Pharmaceuticals Containing Radioactive Iodine: Influence of Plasma Binding.

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