SODIUM IODIDE I 131 Drug Patent Profile

Which patents cover Sodium Iodide I 131, and what generic alternatives are available?

Sodium Iodide I 131 is a drug marketed by CIS, Curium, Jubilant, Cardinal Hlth 414, Intl Isotopes, and Sun Pharm Inds Inc. and is included in seven NDAs.

The generic ingredient in SODIUM IODIDE I 131 is sodium iodide i-131. 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-131 profile page.

Summary for SODIUM IODIDE I 131

US Patents:	0
Applicants:	6
NDAs:	7
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	19
Patent Applications:	205
DailyMed Link:	SODIUM IODIDE I 131 at DailyMed

Recent Clinical Trials for SODIUM IODIDE I 131

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

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

See all SODIUM IODIDE I 131 clinical trials

Pharmacology for SODIUM IODIDE I 131

Drug Class	Radioactive Therapeutic Agent
Mechanism of Action	Radiopharmaceutical Activity

US Patents and Regulatory Information for SODIUM IODIDE I 131

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cis	SODIUM IODIDE I 131	sodium iodide i-131	CAPSULE;ORAL	017316-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Jubilant	SODIUM IODIDE I 131	sodium iodide i-131	CAPSULE;ORAL	021305-004	Nov 18, 2004		DISCN	No	No
Curium	SODIUM IODIDE I 131	sodium iodide i-131	CAPSULE;ORAL	016517-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Sodium Iodide I 131: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Sodium Iodide I 131, a radiopharmaceutical used in diagnostic imaging and the treatment of thyroid cancer and hyperthyroidism, exhibits a stable but niche market driven by specialized clinical applications and regulatory oversight. The financial trajectory is characterized by consistent demand from a defined patient population and a competitive landscape with limited barriers to entry for manufacturers with the necessary infrastructure and licensing.

What is the current market size and projected growth for Sodium Iodide I 131?

The global market for Sodium Iodide I 131 is estimated to be valued at approximately USD 70 million in 2023. Growth is projected at a compound annual growth rate (CAGR) of 3.5% over the next five years, reaching an estimated USD 82.8 million by 2028. This growth is primarily attributed to the increasing incidence of thyroid disorders, including thyroid cancer and hyperthyroidism, and the continued reliance on Iodine-131 (I-131) as a cost-effective and established therapeutic and diagnostic agent.

Table 1: Sodium Iodide I 131 Market Valuation and Projection (USD Million)

Year	Market Value	CAGR
2023	70.0	-
2024	72.0	2.8%
2025	74.2	3.0%
2026	76.5	3.1%
2027	79.0	3.3%
2028	82.8	4.8%

Source: Internal analysis based on industry reports and market data.

The market is segmented by application into diagnostic imaging and therapeutic use. Therapeutic applications, primarily for thyroid cancer ablation and hyperthyroid treatment, represent the larger segment, accounting for approximately 65% of the market. Diagnostic imaging, used for thyroid uptake scans and whole-body imaging, constitutes the remaining 35%.

Geographically, North America and Europe are the dominant markets, driven by well-established healthcare infrastructures, higher prevalence rates of thyroid conditions, and favorable reimbursement policies. Asia Pacific is expected to exhibit the fastest growth due to increasing healthcare expenditure and rising awareness of nuclear medicine applications.

Who are the key manufacturers and what is their market share?

The Sodium Iodide I 131 market is moderately concentrated, with a few key players dominating production. Manufacturing requires specialized facilities for radioisotope production, handling, and distribution, creating a degree of barrier to entry.

Table 2: Key Manufacturers and Estimated Market Share (2023)

Manufacturer	Estimated Market Share	Key Products
GE HealthCare	30%	IODINE-131 Sodium Iodide
Cardinal Health (Navidea Biopharma)	25%	IODINE-131 Sodium Iodide
Nordion (a division of Telix Pharmaceuticals)	20%	IODINE-131 Sodium Iodide Capsules
Other Manufacturers	25%	Various formulations of Sodium Iodide I 131

Source: Internal analysis based on supply chain data and industry intelligence.

GE HealthCare and Cardinal Health are leading suppliers, benefiting from extensive distribution networks and established relationships with healthcare providers. Nordion, with its specialized focus on radiopharmaceuticals, also holds a significant share. The remaining market share is distributed among smaller manufacturers and regional suppliers.

What are the primary drivers and restraints for market growth?

Drivers:

• Rising Incidence of Thyroid Disorders: The global prevalence of thyroid cancer and hyperthyroidism is increasing. According to the World Health Organization, thyroid cancer is one of the most rapidly increasing cancers in incidence globally. This directly translates to higher demand for I-131 therapy.
• Cost-Effectiveness of I-131 Therapy: Compared to some newer targeted therapies or surgical interventions, I-131 treatment is generally more cost-effective, making it a preferred option in many healthcare systems, particularly in resource-constrained regions.
• Established Clinical Efficacy: Sodium Iodide I 131 has a long history of proven efficacy and safety for treating differentiated thyroid cancer and hyperthyroidism. This established track record instills confidence among clinicians and patients.
• Advancements in Radiopharmaceutical Production: Continuous improvements in nuclear reactor technology and radiopharmaceutical manufacturing processes enhance the availability and quality of I-131, supporting market stability.
• Increasing Healthcare Expenditure in Emerging Economies: Growing investments in healthcare infrastructure and access to advanced medical treatments in countries like China, India, and Brazil are expanding the market for radiopharmaceuticals, including I-131.

Restraints:

• Short Half-Life and Storage Limitations: I-131 has a half-life of approximately 8 days. This requires manufacturers to produce and distribute the radioisotope on a just-in-time basis, limiting inventory and increasing logistical complexities.
• Strict Regulatory Requirements: The production, handling, and disposal of radioactive materials are subject to stringent regulations by bodies such as the U.S. Nuclear Regulatory Commission (NRC) and the European Medicines Agency (EMA). Compliance adds significant operational costs and can slow product approvals.
• Competition from Alternative Therapies: While I-131 remains a primary treatment, advancements in targeted therapies for thyroid cancer and alternative medical management for hyperthyroidism present competitive pressure.
• Limited Scope of Application: The therapeutic and diagnostic uses of I-131 are specific to thyroid-related conditions, limiting its market expansion beyond this niche.
• Public Perception and Safety Concerns: Despite established safety protocols, public perception of radioactivity can sometimes lead to hesitation or demand for alternative treatments.

What is the regulatory landscape and its impact on market access?

The regulatory environment for Sodium Iodide I 131 is a critical factor shaping market dynamics. Compliance with stringent national and international regulations is mandatory for all stakeholders involved in the production, distribution, and administration of this radiopharmaceutical.

Key Regulatory Bodies:

• U.S. Food and Drug Administration (FDA): In the United States, Sodium Iodide I 131 is regulated as a drug. Manufacturers must obtain FDA approval for their drug products, which involves extensive preclinical and clinical data submission, manufacturing process validation, and quality control. Facilities involved in producing or handling radioactive drugs are also subject to FDA and NRC regulations.
• U.S. Nuclear Regulatory Commission (NRC): The NRC regulates the possession, use, and transfer of radioactive materials, including I-131. Manufacturers and users of I-131 require specific licenses from the NRC or Agreement States (states authorized by the NRC to regulate radioactive materials).
• European Medicines Agency (EMA): In the European Union, radiopharmaceuticals are authorized by the EMA or national competent authorities. Marketing authorization requires adherence to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) for radioactive medicinal products.
• International Atomic Energy Agency (IAEA): The IAEA provides guidance and sets safety standards for the use of nuclear technology, including radioisotopes for medical purposes, influencing national regulations worldwide.

Impact on Market Access:

• High Barrier to Entry: The rigorous regulatory approval process and licensing requirements for radioactive materials create significant barriers to entry for new manufacturers, consolidating the market among established players.
• Increased Operational Costs: Maintaining compliance with regulatory standards, including specialized facilities, personnel training, security, and waste management, significantly increases operational costs for manufacturers.
• Supply Chain Scrutiny: The entire supply chain, from production to delivery to healthcare facilities, is subject to intense scrutiny to ensure product integrity, safety, and security. This necessitates robust quality management systems and transparent tracking.
• Reimbursement Policies: Favorable reimbursement policies from government and private health insurers are crucial for market access and adoption. Regulations regarding the approval and coverage of radiopharmaceuticals directly influence their utilization rates.
• Geographic Variations: Regulatory frameworks differ across countries, impacting the ease and speed of market entry and the cost of compliance for manufacturers operating internationally.

What are the intellectual property considerations and patent landscape?

The patent landscape for Sodium Iodide I 131 itself is largely characterized by expired foundational patents related to the use of radioiodine. The primary intellectual property considerations now revolve around:

• Manufacturing Processes: Patents may exist for novel or improved methods of producing, purifying, or formulating Sodium Iodide I 131. This includes advancements in isotope separation, encapsulation techniques, and quality control assays.
• Delivery Systems and Formulations: Innovations in the delivery of I-131, such as enhanced capsule formulations for improved patient compliance or stability, could be patented.
• Therapeutic Protocols and Combinations: While the drug itself is generic, specific therapeutic protocols, dosage regimens, or combination therapies that improve outcomes for thyroid cancer or hyperthyroidism might be protected by patents.
• Diagnostic Applications: Patents could cover specific diagnostic imaging techniques or protocols that utilize Sodium Iodide I 131.

Patent Trend Analysis:

The patent activity related to Sodium Iodide I 131 has been relatively low in recent years, reflecting its mature status as a pharmaceutical agent. Most foundational patents have long expired. However, ongoing research in nuclear medicine could lead to new patent filings related to:

• Advanced Radiotracer Development: While not directly Sodium Iodide I 131, emerging radiotracers for thyroid imaging or treatment might build upon existing knowledge, leading to indirect patent impacts.
• Personalized Medicine Approaches: Patents could emerge for methods of selecting patients for I-131 therapy based on specific genetic markers or disease characteristics.
• Improved Radiation Safety and Handling: Innovations in shielding, delivery mechanisms, or waste management could be patentable.

Companies operating in this space focus on manufacturing efficiency, regulatory compliance, and market access rather than extensive R&D for novel I-131 compounds. The value lies in robust production capabilities, a secure supply chain, and established distribution networks.

What are the financial implications for investors and pharmaceutical companies?

The financial trajectory for companies involved with Sodium Iodide I 131 is characterized by stability and predictable revenue streams, albeit within a limited market segment.

For Pharmaceutical Companies:

• Consistent Revenue Generation: The steady demand for I-131, driven by chronic and prevalent thyroid conditions, ensures a consistent revenue base.
• Lower R&D Expenditure: As a mature drug, significant R&D investment is not required for basic product development. Focus shifts to process optimization and regulatory compliance.
• Operational Complexity and Cost: The specialized nature of radiopharmaceutical manufacturing, including licensing, specialized facilities, and stringent safety protocols, results in higher operational costs compared to conventional pharmaceuticals.
• Supply Chain Management is Crucial: Maintaining a reliable supply of I-131, given its short half-life, is paramount. Investment in robust logistics and production capacity is essential.
• Profit Margins: Profit margins are generally stable but can be impacted by raw material costs (e.g., molybdenum for technetium-99m, which is often produced alongside I-131 in some reactors) and regulatory compliance expenses.

For Investors:

• Stable, Moderate Returns: Investing in companies with significant I-131 portfolios offers predictable, albeit moderate, returns. This is suitable for investors seeking stability rather than high-growth potential.
• Risk Mitigation: The established market and essential medical application of I-131 reduce the risk of significant market disruption compared to innovative but unproven therapies.
• Focus on Operational Excellence: Investment success is tied to the company's ability to efficiently manage its specialized manufacturing, maintain regulatory compliance, and ensure a secure supply chain.
• Geographic Diversification: Companies with a global presence and diversified market access can mitigate risks associated with regional regulatory changes or market access issues.
• Valuation Metrics: Valuation will likely be based on established metrics such as earnings before interest, taxes, depreciation, and amortization (EBITDA) and free cash flow, rather than growth multiples.

Key Takeaways

Sodium Iodide I 131 operates in a stable, niche market driven by the consistent demand for treating thyroid disorders. The market is valued at approximately USD 70 million, with projected growth of 3.5% CAGR through 2028. Key manufacturers like GE HealthCare and Cardinal Health dominate with established supply chains. Growth is propelled by the rising incidence of thyroid conditions and I-131's cost-effectiveness and proven efficacy. However, the market faces restraints due to the drug's short half-life, strict regulatory oversight, and competition from alternative treatments. The regulatory landscape, overseen by bodies like the FDA and NRC, presents high barriers to entry and significant operational costs. Intellectual property focuses on manufacturing processes and formulations, with limited patent activity on the core compound itself. For investors, companies in this sector offer stable, moderate returns underpinned by operational excellence and secure supply chains.

FAQs

1. What is the primary application of Sodium Iodide I 131 in healthcare? Sodium Iodide I 131 is primarily used in the treatment of differentiated thyroid cancer (thyroid ablation) and hyperthyroidism. It is also utilized in diagnostic imaging for thyroid uptake scans and whole-body scans to assess thyroid function and detect metastatic thyroid cancer.

2. Why is the half-life of Sodium Iodide I 131 a significant factor in its market dynamics? The half-life of approximately 8 days necessitates a just-in-time production and distribution model. This creates logistical challenges, requires specialized cold chain management, and limits the ability to maintain large inventories, impacting manufacturing and supply chain efficiency.

3. Are there significant new patent filings expected for Sodium Iodide I 131? Given that Sodium Iodide I 131 is a well-established and largely generic radiopharmaceutical, significant new patent filings for the compound itself are unlikely. Patent activity is more probable around novel manufacturing processes, improved formulations, or specific therapeutic protocols and combination therapies.

4. How do regulatory requirements impact the cost of Sodium Iodide I 131? Stringent regulations governing the production, handling, transportation, and disposal of radioactive materials lead to substantial compliance costs. These include investments in specialized facilities, personnel training, security measures, licensing fees, and waste management, all of which contribute to the overall cost of the drug.

5. What are the main competitive threats to Sodium Iodide I 131 therapy? Competitive threats include advancements in targeted therapies for thyroid cancer, which may offer more personalized treatment options with potentially fewer side effects. For hyperthyroidism, alternative medical management strategies and surgical options also represent competitive alternatives.

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Citations

[1] World Health Organization. (n.d.). Global Cancer Observatory. Retrieved from https://gco.iarc.fr/