Generic SODIUM IODIDE I-123 INN equivalents, drug patent and freedom to operate

Sponsor	Phase
National University of Malaysia	PHASE2
University Health Network, Toronto	Phase 4
Stryker Endoscopy	Phase 4

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	SODIUM IODIDE I 123	sodium iodide i-123	SOLUTION;ORAL	017630-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Cardinal Health 418	SODIUM IODIDE I 123	sodium iodide i-123	CAPSULE;ORAL	018671-001	May 27, 1982	AA	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Curium	SODIUM IODIDE I 123	sodium iodide i-123	CAPSULE;ORAL	071909-001	Feb 28, 1989	AA	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Ge Healthcare	SODIUM IODIDE I 123	sodium iodide i-123	CAPSULE;ORAL	017630-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Curium	SODIUM IODIDE I 123	sodium iodide i-123	CAPSULE;ORAL	071910-001	Feb 28, 1989	AA	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: February 19, 2026

Sodium Iodide I-123 is a radiopharmaceutical used in diagnostic imaging, primarily for assessing thyroid function and detecting certain cancers. Its market is influenced by regulatory approvals, technological advancements in nuclear medicine, and the prevalence of target diseases. The financial trajectory of Sodium Iodide I-123 products is tied to manufacturing costs, distribution challenges associated with short-lived isotopes, and reimbursement policies.

What are the primary applications of Sodium Iodide I-123?

Sodium Iodide I-123 (NaI-123) is primarily utilized in diagnostic nuclear medicine for its ability to emit gamma rays detectable by SPECT (Single-Photon Emission Computed Tomography) scanners. Its primary applications include:

Thyroid Imaging: NaI-123 is the radiotracer of choice for evaluating thyroid gland function, including assessing conditions like hyperthyroidism, hypothyroidism, and nodular thyroid disease. It allows for the visualization of the thyroid's uptake and distribution of iodine, providing critical diagnostic information.
Differentiated Thyroid Cancer Detection: Following thyroidectomy for differentiated thyroid cancer (papillary and follicular types), NaI-123 scans are used to detect residual thyroid tissue or metastatic disease.
Parathyroid Imaging: In conjunction with other imaging agents, NaI-123 can aid in the localization of hyperfunctioning parathyroid adenomas, a common cause of hyperparathyroidism.
Myocardial Perfusion Imaging: While less common than other agents, NaI-123 labeled fatty acids can be used to assess blood flow to the heart muscle, identifying areas of ischemia or infarction.

Who are the key manufacturers and suppliers of Sodium Iodide I-123?

The production and supply chain for radiopharmaceuticals like Sodium Iodide I-123 are complex due to the short half-life of the isotope (approximately 13.2 hours). Key entities involved in its manufacturing and supply include:

GE HealthCare: A significant player in the nuclear medicine market, GE HealthCare produces and distributes radiopharmaceuticals, including I-123 based products. Their offerings often integrate with their imaging equipment.
Nordion (a Sotera Health company): Nordion is a global provider of radiopharmaceuticals and medical isotopes. They are involved in the production and distribution of I-123, catering to healthcare facilities.
Other Specialized Radiopharmaceutical Producers: Several smaller, specialized companies operate globally, focusing on the synthesis and distribution of various radioisotopes for medical use. These can include regional suppliers who may have dedicated cyclotrons or radiopharmacies to produce and deliver short-lived isotopes.

The supply chain necessitates robust logistical networks to ensure timely delivery from production sites to imaging centers.

What is the current market size and projected growth for Sodium Iodide I-123?

The market for Sodium Iodide I-123 is a segment within the broader radiopharmaceuticals market, which is experiencing steady growth. Precise figures for NaI-123 alone are often subsumed within broader radiopharmaceutical market reports.

Estimated Market Share: While specific data for NaI-123 is not universally segmented, it represents a vital component of diagnostic nuclear medicine. The global radiopharmaceuticals market was valued at approximately $5.3 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 7.5% to reach over $9 billion by 2029 [1, 2]. NaI-123 contributes to this market through its established diagnostic utility.
Growth Drivers: Growth is driven by an increasing aging population, a higher prevalence of thyroid disorders and cancers, and advancements in SPECT imaging technology that improve diagnostic accuracy. The expanding use of nuclear medicine in oncology and neurology also contributes to the overall radiopharmaceutical market expansion.
Challenges: The market faces challenges related to the inherent instability and short half-life of I-123, which impacts production, transportation, and storage. High manufacturing costs, regulatory hurdles, and competition from alternative diagnostic modalities can also influence market dynamics.

What are the key regulatory considerations for Sodium Iodide I-123?

The production, distribution, and clinical use of Sodium Iodide I-123 are subject to stringent regulatory oversight by national and international health authorities.

FDA Approval (United States): In the U.S., the Food and Drug Administration (FDA) regulates radiopharmaceuticals. Manufacturers must obtain FDA approval for new drug applications (NDAs) or supplemental applications for any new formulations or indications of NaI-123 products. This involves rigorous review of manufacturing processes, quality control, preclinical and clinical data demonstrating safety and efficacy [3].
Radioactive Material Licensing: Facilities that manufacture, possess, or use radioactive materials like I-123 require specific licenses from regulatory bodies such as the Nuclear Regulatory Commission (NRC) in the U.S., or equivalent agencies internationally. These licenses dictate strict protocols for handling, storage, security, and disposal of radioactive substances.
Good Manufacturing Practices (GMP): Manufacturers must adhere to current Good Manufacturing Practices (cGMP) as mandated by regulatory agencies. This ensures the consistent quality, purity, and potency of the radiopharmaceutical, which is critical for patient safety and diagnostic reliability.
International Regulations: Similar regulatory frameworks exist in other major markets, such as the European Medicines Agency (EMA) in Europe, Health Canada, and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. These agencies evaluate radiopharmaceuticals based on their own scientific and regulatory standards.
Reimbursement Policies: While not direct regulatory approval of the drug itself, reimbursement policies set by government payers (e.g., Medicare in the U.S.) and private insurers significantly influence market access and adoption. These policies dictate whether and how much healthcare providers are reimbursed for procedures utilizing NaI-123, impacting demand.

What are the principal challenges in the manufacturing and supply of Sodium Iodide I-123?

The production and distribution of Sodium Iodide I-123 are complicated by the inherent properties of radioactive isotopes.

Short Half-Life: I-123 has a half-life of approximately 13.2 hours. This necessitates on-demand production and rapid, efficient distribution to healthcare facilities. Delays in production or transportation can result in significant product loss due to radioactive decay.
Production Complexity: I-123 is typically produced in cyclotrons via the reaction of enriched tellurium targets with protons or deuterons. This requires specialized equipment, highly trained personnel, and strict quality control measures to ensure the desired isotopic purity and to minimize radioactive contamination.
Logistical Demands: The short shelf-life demands a highly coordinated and specialized cold chain logistics network. Suppliers must maintain precise delivery schedules to reach hospitals and imaging centers before the isotope decays significantly, impacting its diagnostic utility. This also contributes to higher transportation costs.
Radiological Safety and Security: Strict protocols for radiation shielding, containment, waste management, and security are paramount throughout the manufacturing and distribution process. This involves significant investment in infrastructure and ongoing compliance with rigorous safety regulations.
Cost of Production: The specialized equipment (cyclotrons), raw materials (enriched isotopes), stringent quality control, and complex logistics contribute to the relatively high cost of producing and delivering radiopharmaceuticals like NaI-123.

How does Sodium Iodide I-123 compare to alternative diagnostic imaging agents?

Sodium Iodide I-123 is a well-established agent, but it faces competition from other isotopes and imaging modalities depending on the specific diagnostic application.

Technetium-99m (Tc-99m): Tc-99m is the most widely used radioisotope in nuclear medicine due to its optimal gamma energy (140 keV), short half-life (6 hours), and ready availability from molybdenum-99 (Mo-99) generators. For many thyroid uptake and imaging procedures, Tc-99m pertechnetate is a viable, and often more cost-effective, alternative to NaI-123, especially in facilities without direct access to cyclotron-produced isotopes. However, NaI-123 offers superior resolution and is preferred for certain functional assessments and post-therapy scans due to its higher energy gamma rays and specific uptake mechanisms.
Iodine-131 (I-131): I-131 has a longer half-life (8 days) than I-123, making it easier to handle and store. It is often used for both diagnostic imaging and therapeutic applications (e.g., treatment of hyperthyroidism and thyroid cancer). However, I-131 emits both gamma rays for imaging and beta particles, which contribute to a higher radiation dose to the patient. Its gamma emission energy is also higher than ideal for SPECT imaging, leading to poorer image quality compared to I-123.
Fluorine-18 (F-18) labeled agents (e.g., FDG for PET): Positron Emission Tomography (PET) agents, particularly Fluorodeoxyglucose (FDG) labeled with F-18, offer higher sensitivity and resolution than SPECT imaging for detecting metabolic activity. F-18 FDG is widely used in oncology for staging and monitoring treatment response. While PET is generally more expensive and requires different imaging equipment, its superior diagnostic performance in certain indications, especially for detecting occult metastases, presents a competitive alternative to SPECT imaging with NaI-123 for cancer detection.
MRI and CT: Magnetic Resonance Imaging (MRI) and Computed Tomography (CT) are non-radioactive imaging modalities that provide excellent anatomical detail. They are often used as complementary or alternative diagnostic tools, particularly for structural abnormalities and certain types of cancer staging where metabolic information from nuclear medicine may be secondary to detailed anatomical visualization.

The choice of imaging agent or modality depends on the specific clinical question, required diagnostic information (functional vs. anatomical), radiation dose considerations, cost, and availability of equipment and isotopes.

What is the financial outlook for companies involved with Sodium Iodide I-123?

The financial outlook for companies manufacturing and supplying Sodium Iodide I-123 is moderately positive, driven by sustained demand in diagnostic nuclear medicine, but tempered by the inherent complexities of radiopharmaceutical production.

Stable Revenue Streams: Established radiopharmaceutical companies with a portfolio that includes NaI-123 benefit from stable, recurring revenue streams. The diagnostic utility of NaI-123 for thyroid conditions and certain cancers ensures consistent demand.
High Barriers to Entry: The significant capital investment required for cyclotron facilities, strict regulatory compliance, and specialized logistical networks create high barriers to entry for new competitors. This can provide a competitive advantage for incumbent players.
Manufacturing Costs: Ongoing high costs associated with isotope production, quality control, and specialized distribution can impact profit margins. Companies must optimize their production processes and supply chains to maintain cost-effectiveness.
Technological Advancements: Investment in next-generation cyclotron technology, more efficient radiochemistry, and improved distribution models can lead to operational efficiencies and potentially higher margins.
Market Growth in Nuclear Medicine: The broader expansion of nuclear medicine, driven by increased adoption in oncology, neurology, and cardiology, positively influences the market for all radiopharmaceuticals, including NaI-123.
Diversification: Companies that diversify their radiopharmaceutical offerings, including therapeutic isotopes or novel diagnostic agents, can mitigate risks associated with single-product dependence and capitalize on emerging market opportunities.
Reimbursement Environment: Favorable reimbursement policies for nuclear medicine procedures are critical. Any changes that reduce reimbursement rates could negatively impact revenue for providers and, consequently, demand for the agents.

Companies focusing on efficiency, regulatory compliance, and strategic partnerships within the nuclear medicine ecosystem are best positioned for financial success.

Key Takeaways

Sodium Iodide I-123 is a critical radiopharmaceutical for thyroid diagnostics and differentiated thyroid cancer detection, utilizing SPECT imaging.
Key global manufacturers include GE HealthCare and Nordion, supported by a complex supply chain due to the isotope's short half-life.
The radiopharmaceutical market, which includes NaI-123, is projected to grow steadily, driven by an aging population and increased disease prevalence.
Strict FDA and international regulatory oversight, including GMP, governs the production and use of NaI-123.
Manufacturing and supply face challenges from the isotope's short half-life, requiring specialized production and rapid logistics, contributing to high costs.
NaI-123 competes with other isotopes like Tc-99m and I-131, as well as advanced modalities like PET, depending on the clinical application.
The financial outlook for companies involved with NaI-123 is positive but depends on managing high production costs, navigating regulatory landscapes, and benefiting from the overall growth of nuclear medicine.

Frequently Asked Questions

1. What is the primary reason for the short shelf-life of Sodium Iodide I-123?

The short shelf-life of Sodium Iodide I-123 is due to its intrinsic radioactive decay rate, quantified by its half-life of approximately 13.2 hours. This means that every 13.2 hours, half of the radioactive atoms in a given sample of I-123 will have decayed into a stable isotope.

2. How is Sodium Iodide I-123 produced?

Sodium Iodide I-123 is typically produced in a medical cyclotron. The most common method involves bombarding enriched tellurium targets with protons or deuterons. For example, the reaction of enriched tellurium-122 with protons can produce I-123. Following irradiation, chemical separation and purification processes are employed to isolate and prepare the radiopharmaceutical.

3. What is the typical radiation dose associated with a Sodium Iodide I-123 scan?

The radiation dose from a Sodium Iodide I-123 scan varies depending on the administered activity and the specific diagnostic procedure. For standard diagnostic thyroid uptake and imaging, the effective dose is generally in the range of 0.5 to 2 millisieverts (mSv). This dose is considered low and comparable to doses received from other medical imaging procedures or natural background radiation over a year.

4. Can Sodium Iodide I-123 be used for therapeutic purposes?

Sodium Iodide I-123 is primarily used for diagnostic imaging. While it is an iodine isotope, its relatively short half-life and lower energy emissions make it less suitable for therapeutic purposes compared to Iodine-131 (I-131). I-131, with its longer half-life and beta particle emission, is used therapeutically to treat hyperthyroidism and differentiated thyroid cancer by delivering a higher radiation dose to target cells.

5. What are the main advantages of using Sodium Iodide I-123 over other SPECT imaging agents?

Sodium Iodide I-123 offers several advantages for SPECT imaging. Its gamma emission at 159 keV is well-suited for detection by standard SPECT cameras, providing good image resolution and contrast. Its specific uptake mechanism in thyroid tissue and certain tumor cells allows for functional assessment of these tissues. Compared to I-131, it delivers a significantly lower radiation dose to the patient, making it preferable for diagnostic imaging where therapeutic effects are not intended.

Citations

[1] Grand View Research. (2023). Radiopharmaceuticals Market Size, Share & Trends Analysis Report. Retrieved from https://www.grandviewresearch.com/industry-analysis/radiopharmaceuticals-market

[2] Verified Market Research. (2023). Radiopharmaceuticals Market - Forecasts From 2019 To 2026. Retrieved from https://www.verifiedmarketresearch.com/product/radiopharmaceuticals-market-size-and-forecast-to-2026/

[3] U.S. Food & Drug Administration. (n.d.). Investigational New Drug (IND) Application. Retrieved from https://www.fda.gov/drugs/investigational-new-drug-application-ind/investigational-new-drug-ind-application

US Patents:	0
Tradenames:	1
Applicants:	3
NDAs:	4
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	19
DailyMed Link:	sodium iodide i-123 at DailyMed

Sodium iodide i-123 - Generic Drug Details

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