SODIUM IODIDE I-131 - Generic Drug Details

What are the generic sources for sodium iodide i-131 and what is the scope of patent protection?

Sodium iodide i-131 is the generic ingredient in three branded drugs marketed by Bracco, CIS, Curium, Jubilant, Cardinal Hlth 414, Intl Isotopes, and Sun Pharm Inds Inc, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for sodium iodide i-131. Two suppliers are listed for this compound.

Summary for SODIUM IODIDE I-131

US Patents:	0
Tradenames:	3
Applicants:	7
NDAs:	8
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	8
Clinical Trials:	19
What excipients (inactive ingredients) are in SODIUM IODIDE I-131?	SODIUM IODIDE I-131 excipients list
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
Intl Isotopes	SODIUM IODIDE I 131	sodium iodide i-131	SOLUTION;ORAL	209166-001	Feb 5, 2020	AA	RX	No	No
Jubilant	SODIUM IODIDE I 131	sodium iodide i-131	CAPSULE;ORAL	021305-006	May 19, 2005		RX	Yes	No
Bracco	IODOTOPE	sodium iodide i-131	CAPSULE;ORAL	010929-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Jubilant	HICON	sodium iodide i-131	SOLUTION;ORAL	021305-007	Dec 5, 2011	AA	RX	Yes	Yes
Jubilant	SODIUM IODIDE I 131	sodium iodide i-131	CAPSULE;ORAL	021305-004	Nov 18, 2004		DISCN	No	No
Jubilant	HICON	sodium iodide i-131	SOLUTION;ORAL	021305-002	Jan 24, 2003		DISCN	No	No
Cis	SODIUM IODIDE I 131	sodium iodide i-131	CAPSULE;ORAL	017316-002	Approved Prior to Jan 1, 1982		DISCN	No	No

SODIUM IODIDE I-131 Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for Sodium Iodide I-131?

Sodium iodide I-131 (I-131) is a radioactive isotope primarily used for diagnostic imaging and therapeutic treatment of thyroid-related conditions, notably thyroid cancer and hyperthyroidism. Its market is influenced by clinical demand, regulatory policies, manufacturing capacity, and competition from alternative therapies.

Clinical and Regulatory Drivers

The clinically established efficacy of I-131 for thyroid cancer treatment sustains steady demand. The American Thyroid Association reports an annual increase in thyroid cancer diagnoses, with an estimated 52,000 new cases in the United States in 2022, and I-131 remains a core treatment modality [1].

Regulatory approvals, such as the U.S. Food and Drug Administration's (FDA) clearance of I-131 therapies, support market stability. The drug is classified as a radiopharmaceutical, subject to strict guidelines from the Nuclear Regulatory Commission (NRC). Expedited approvals for new formulations intended to improve safety or administration ease influence market growth.

Manufacturing and Supply Chain Factors

The production of I-131 involves neutron irradiation of tellurium targets in nuclear reactors, making supply vulnerable to reactor outages and geopolitical issues affecting nuclear infrastructure. Global capacity concentrates in a few countries, notably the United States and Russia, which influence price stability and supply reliability.

The expiration of existing licenses or stricter regulations on nuclear reactors could constrain supply. Conversely, investments in new production facilities or alternative reactors could enhance capacity.

Competitive Landscape

While I-131 remains dominant for thyroid cancer, emerging therapies such as tyrosine kinase inhibitors and novel targeted agents challenge its long-term market share. These alternatives are mainly reserved for cases resistant to I-131 therapy, which constitute about 10-20% of thyroid cancer patients [2].

However, no bioequivalent alternatives currently match I-131's established efficacy and safety profile. This solidifies its position, though innovations in radiopharmaceuticals might alter dynamics over the next decade.

Market Size and Revenue Trends

The global radiopharmaceuticals market, including I-131, was valued at approximately $4.2 billion in 2021, with segment-specific figures challenging due to proprietary data. I-131 accounts for a significant share, with hundreds of thousands of doses administered worldwide annually.

In the United States alone, approximately 70,000-80,000 doses are dispensed annually for therapeutic purposes [3]. Pricing per dose typically ranges from $500 to $1,500, depending on formulation and administration setting. Revenue growth is modest, averaging 2-4% annually, driven by increased thyroid cancer diagnoses and improved treatment protocols.

Policy Impact and Reimbursement

Reimbursement policies from Medicare and private insurers favor established radiopharmaceuticals like I-131, supporting ongoing use. However, healthcare policies promoting alternative treatments or cost-containment measures could influence the economic landscape.

Future Market Trajectory

Long-term growth will depend on:

• Continued rise in thyroid cancer cases.
• Enhanced nuclear medicine infrastructure.
• Development of next-generation radiopharmaceuticals.
• Regulatory environment stability.

Projected compound annual growth rate (CAGR) for the I-131 segment is approximately 2-3% through 2030.

What Is the Financial Trajectory of Sodium I-131?

Revenue Outlook

Based on current demand levels and market penetration, revenues are expected to grow modestly. The global market could reach approximately $6 billion by 2030, with I-131 comprising a significant portion.

Cost Factors

Manufacturing expenses hinge on reactor operation costs, which are influenced by energy prices, regulatory compliance, and reactor maintenance. Storage and disposal of radioactive waste add further costs, impacting overall margins.

Pricing Trends

Pricing may increase in response to supply constraints or technology upgrades but remains restrained by healthcare payers and competitive offerings. Volume growth offsets price stability, maintaining revenue streams.

Investment and R&D Spending

Major pharmaceutical companies and radiopharmaceutical manufacturers invest in production capacity expansion and new formulations. R&D expenditure is relatively limited given the established clinical utility but could rise if new therapeutic indications or delivery methods are developed.

Risk Factors

• Supply disruptions due to geopolitical or regulatory issues.
• Competition from alternative thyroid therapies.
• Reimbursement reductions.
• Advances in personalized medicine diminishing reliance on traditional I-131 therapy.

What Are the Key Takeaways?

• Demand for I-131 remains stable, driven by its role in thyroid cancer management.
• Supply chain vulnerabilities stemming from nuclear reactor dependencies influence market stability.
• Competitive pressures are low, but emerging therapies could reduce future market share.
• Revenue growth is modest, with projections indicating a CAGR of 2-3% till 2030.
• Cost and regulatory factors remain significant, influencing supply prices and market entry.

FAQs

1. How does supply chain security impact I-131 prices?
Limited production capacity and reliance on nuclear reactors subject to outages create supply variability that can drive price fluctuations.

2. What factors could accelerate the market growth for I-131?
Increased thyroid cancer diagnoses, regulatory approvals of new formulations, and investments in manufacturing infrastructure.

3. Are alternative therapies likely to replace I-131?
Currently, no alternatives match I-131’s efficacy. However, novel targeted therapies and systemic treatments may reduce its use in selected cases over time.

4. How do regulatory changes influence the I-131 market?
Stringent nuclear safety regulations can slow production expansion or increase compliance costs, affecting availability and pricing.

5. What role does healthcare policy play in I-131 reimbursement?
Reimbursement policies favor established radiopharmaceuticals; shifts toward value-based care could modify coverage and utilization patterns.

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References

[1] American Thyroid Association. "Thyroid Cancer Statistics." 2022.
[2] Haugen, B. R., et al. "2015 American Thyroid Association Management Guidelines for Adult Patients with Thyroid Nodules and Differentiated Thyroid Cancer." Thyroid, 2016.
[3] MarketWatch. "Global Radiopharmaceutical Market Size, Share & Trends." 2022.