IOTHALAMATE SODIUM I-125 - Generic Drug Details

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

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	6
Patent Applications:	119
DailyMed Link:	IOTHALAMATE SODIUM I-125 at DailyMed

Recent Clinical Trials for IOTHALAMATE SODIUM I-125

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

Sponsor	Phase
Mayo Clinic	Phase 2
Mayo Clinic	Phase 1
National Institutes of Health (NIH)	Phase 1

See all IOTHALAMATE SODIUM I-125 clinical trials

Pharmacology for IOTHALAMATE SODIUM I-125

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

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

Market Dynamics and Financial Trajectory for Iothalamate Sodium I-125

Last updated: February 14, 2026

What is Iothalamate Sodium I-125?

Iothalamate sodium I-125 is a radiopaque contrast agent integrated with iodine-125, a radioisotope used mainly in diagnostic imaging. Its applications are primarily in radiology, especially for precise localization in medical procedures like lymph node mapping, tumor localization, and certain cancer diagnostics.

What is the Current Market Size and Growth?

The global radiopaque contrast agent market, which includes Iothalamate sodium I-125 as a niche segment, was valued at approximately $2.7 billion in 2022. Iodine-125's specific application in contrast agents accounts for less than 1% of this market, estimated at roughly $25 million in annual revenues, with a projected compound annual growth rate (CAGR) of 4%-5% over the next five years.

What are the Factors Driving Demand?

1. Increasing prevalence of cancers: Growing incidences of prostate, breast, and other cancers requiring localization and imaging procedures support demand.
2. Enhanced diagnostic techniques: Improved imaging resolution and precision increase the utilization of targeted contrast agents.
3. Medical device innovation: Development of nanoparticles and enhanced delivery systems for iodine-125 improve clinical outcomes.
4. Regulatory approval: Existing approvals in major markets like the U.S. and European Union favor continued use and potential new indication approvals.

What Are the Market Challenges?

1. Limited therapeutic applications: Iothalamate sodium I-125 primarily offers diagnostic utility; it does not have therapeutic benefits, limiting growth potential.
2. Radioisotope sourcing constraints: Dependence on uranium target production impacts supply stability and cost.
3. Stringent regulatory environment: Safety concerns associated with radioisotope use, including radiation exposure risks, require compliance and oversight, adding to costs and delaying market entry for new formulations.
4. Competing technologies: Advances in MRI and PET imaging, which do not involve radioactive agents, offer alternative diagnostic options.

What is the Competitive Landscape?

Key firms involved include:

• GE HealthCare: Supplies iodine-based contrast agents, including specialized formulations.
• Nordion (a part of MDS Inc.): Supplies iodine-125 sources mainly for brachytherapy but influences supply chain dynamics.
• Small niche biopharmaceutical firms: Focus on developing radioconjugates with iodine-125 for diagnostic precision.

These companies focus mainly on development, manufacturing, and supply chain optimization, with limited direct competition within the I-125 contrast segment due to the specialized nature.

What are the Regulatory and Policy Influences?

• Drug approval pathways: Permits from FDA, EMA, and other agencies govern clinical use, with ongoing requirements for safety monitoring.
• Radioisotope regulations: Restrictions pertain to handling, transportation, and disposal, increasing operational complexity.
• Reimbursement policies: Variations across regions, with US Medicare and private insurers covering certain diagnostic procedures, influence market demand.

What is the Forecast for the Financial Trajectory?

• Revenue growth: Expected modest growth of 4%-5% annually, driven by increasing cancer diagnostic needs.
• Pricing dynamics: Stable amid controlled supply, but potential for price increases due to regulatory hurdles and sourcing constraints.
• R&D investments: Likely to remain steady or increase slightly to develop alternative isotopes or enhanced delivery systems.
• Market risks: Regulatory changes, supply chain disruptions, and competition from emerging imaging modalities.

Summary of Financial Outlook

Factor	Expectation
Market size (2022)	$25 million
Projected CAGR (2023-2028)	4-5%
Revenue in 2028	Approximately $31-$33 million
Investment in R&D	Stable to slight increase
Major risk factors	Supply stability, regulatory environment, competition

Final Observations

Iothalamate sodium I-125 remains a niche yet stable segment within nuclear medicine. Its growth hinges on the expanding need for precise cancer diagnostics and advancements in isotope production. Limited therapeutic applications and regulatory challenges constrain rapid expansion.

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Key Takeaways

• The global market for Iothalamate sodium I-125 is small but growing due to increasing cancer diagnostics.
• Demand is driven by advances in imaging and localized treatment procedures.
• Supply constraints and regulatory hurdles pose risks to market stability.
• The revenue trajectory projects modest growth, with a compound annual rate around 4%-5% over the next five years.
• Competition from alternative imaging modalities could influence future market demand.

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FAQs

1. What clinical applications does Iothalamate sodium I-125 primarily serve?
It is used mainly for diagnostic procedures like tumor and lymph node localization, particularly in cancer surgeries.

2. How does the sourcing of iodine-125 impact its market?
Limited production capacity for iodine-125, stemming from uranium target processing, restricts supply and can influence pricing and availability.

3. What are the main regulatory hurdles?
Radioisotope handling regulations, safety procedures, waste management, and approval pathways for new formulations affect market entry and expansion.

4. Are there emerging alternatives to Iothalamate sodium I-125?
Yes. Advances in MRI and PET imaging are providing non-radioactive diagnostic options, potentially reducing reliance on radioactive agents.

5. What potential developments could influence the market’s growth?
Innovations in isotope production, new diagnostic indications, or enhanced delivery methods may expand applications and improve profitability.

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Sources:
[1] Markets and Markets, "Radiopaque Contrast Agents Market," March 2023.
[2] GlobalData, "Nuclear Medicine Imaging Agents Report," December 2022.
[3] U.S. FDA, "Radiopharmaceuticals Regulations," 2023.
[4] SI Radiology, "Application of Iodine-125 in Cancer Imaging," 2021.
[5] World Nuclear Association, "Iodine-125 Production and Supply," 2022.