You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 19, 2026

SODIUM IODIDE I 123 Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Sodium Iodide I 123, and when can generic versions of Sodium Iodide I 123 launch?

Sodium Iodide I 123 is a drug marketed by Cardinal Health 418, Curium, and Ge Healthcare. and is included in four NDAs.

The generic ingredient in SODIUM IODIDE I 123 is sodium iodide i-123. There are one thousand four hundred and seventy-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sodium iodide i-123 profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for SODIUM IODIDE I 123?
  • What are the global sales for SODIUM IODIDE I 123?
  • What is Average Wholesale Price for SODIUM IODIDE I 123?
Summary for SODIUM IODIDE I 123
US Patents:0
Applicants:3
NDAs:4

US Patents and Regulatory Information for SODIUM IODIDE I 123

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cardinal Health 418 SODIUM IODIDE I 123 sodium iodide i-123 CAPSULE;ORAL 018671-001 May 27, 1982 AA RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ge Healthcare SODIUM IODIDE I 123 sodium iodide i-123 CAPSULE;ORAL 017630-003 Jan 8, 1993 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Curium SODIUM IODIDE I 123 sodium iodide i-123 CAPSULE;ORAL 071909-001 Feb 28, 1989 AA RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

SODIUM IODIDE I 123 Market Analysis and Financial Projection

Last updated: February 3, 2026

What Is the Investment Potential of SODIUM IODIDE I 123?

Sodium Iodide I-123 (Iodine-123) is a radiopharmaceutical primarily used for diagnostic imaging in nuclear medicine. Its production involves complex, high-cost technical processes, and its clinical applications are specialized. Investment considerations hinge on global demand in medical imaging, manufacturing capacity, regulatory environment, and competition from alternative imaging agents.

What Is the Market Size and Growth Outlook?

The global nuclear medicine market was valued at approximately $6 billion in 2022 with a compound annual growth rate (CAGR) near 7% (source [1]). SPECT imaging, which relies heavily on I-123, accounts for a significant segment. I-123 applications include thyroid scans, neuroendocrine tumor imaging, and cardiac imaging.

Key points:

  • The demand for I-123 is tied to the growth in nuclear medicine procedures, which expected to rise about 6-8% annually over the next five years.

  • I-123's market share within radiopharmaceuticals is stable but faces competition from PET isotopes like F-18, particularly in emerging markets.

  • Supply chain constraints, limited production facilities, and quality controls influence pricing and availability.

What Are the Technical and Regulatory Barriers?

Production of I-123 requires a cyclotron and radiochemical facilities complying with Good Manufacturing Practices (GMP). These facilities are scarce and expensive to establish.

Regulatory hurdles involve approvals from agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Approvals encompass data on safety, efficacy, and manufacturing standards.

  • The complexity of regulatory pathways can delay market penetration for new suppliers or formulations.

  • Ensuring radiation safety and stable supply chain management remains critical.

What Are the Competitive and Alternative Imaging Agents?

Other isotopes and imaging modalities target similar clinical needs:

  • Technetium-99m (Tc-99m) is the dominant isotope, used across various radiotracers but does not replace I-123’s specific application in thyroid and neuroendocrine imaging.

  • Fluorine-18 (F-18) labeled compounds in PET offer superior resolution but entail higher costs and require cyclotron facilities.

  • SPECT imaging's lower resolution compared to PET limits its adoption in some clinical contexts, though I-123 remains relevant for specific diagnostic uses.

What Are Manufacturing and Supply Chain Risks?

Manufacturing of I-123 is technically demanding, with production cycles of approximately 13 hours due to its 13-hour half-life.

Supply chain risks include:

  • Dependence on a limited number of cyclotron facilities.

  • Logistic challenges in distribution to treatment centers, especially in remote locations.

  • Potential for supply shortages, impacting revenue stability.

What Are Pricing and Reimbursement Factors?

Reimbursement in major markets is influenced by complex policies:

  • In the U.S., Medicare and private insurers reimburse for I-123 procedures based on national fee schedules.

  • Reimbursement rates are sensitive to clinical guidelines and competing diagnostic modalities.

Pricing for I-123 varies, generally around $200–$500 per dose, influenced by manufacturing costs and distribution logistics.

Investment Risks and Opportunities

Risks:

  • Regulatory delays or rejections.

  • Supply shortages leading to market share loss.

  • Competition from PET tracers and other diagnostic modalities.

  • Limited number of production facilities elevating entry barriers.

Opportunities:

  • Growing nuclear medicine procedures in emerging markets.

  • Technological improvements reducing production costs.

  • Expanding clinical indications, including new diagnostic protocols.

  • Potential partnerships with established radiopharmaceutical companies.

Final Analysis

Sodium Iodide I-123 operates within a niche but expanding segment of nuclear medicine. Growth potential is primarily driven by increased adoption of thyroid and neuroendocrine imaging. High barriers to production and regulatory approval limit new entrants, consolidating market power among established producers.

Long-term investment hinges on maintaining supply stability, navigating regulatory pathways efficiently, and expanding clinical applications. Competitive pressures from PET-based diagnostics remain a challenge but do not immediately threaten I-123's core role.

Key Takeaways

  • The I-123 market is driven by nuclear medicine procedure growth, with global demand increasing 6-8% annually.

  • Production relies on specialized cyclotrons and GMP-compliant facilities, limiting market entry.

  • Clinical applications focus on thyroid and neuroendocrine imaging, with some competition from PET tracers.

  • Supply chain and regulatory hurdles present notable risks to revenue continuity.

  • Emerging markets and technological advancements may offer growth opportunities.

FAQs

  1. What are the main clinical uses of Sodium Iodide I-123?
    Diagnostics for thyroid function, neuroendocrine tumors, and cardiac imaging.

  2. How does regulatory approval impact market entry?
    Stringent safety and efficacy standards can delay approval, increasing costs and time to market.

  3. What competitive factors influence I-123 pricing?
    Manufacturing complexity, supply chain logistics, and reimbursement policies.

  4. Can emerging PET technology replace I-123?
    PET offers higher resolution but is more costly and infrastructure-dependent, making I-123 still relevant for specific uses.

  5. What are the main supply risks for I-123?
    Limited production facilities, short half-life necessitating timely logistics, and regulatory barriers.


Sources
[1] Research and Markets. "Global Nuclear Medicine Market," 2022.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.