SODIUM IODIDE I 131 Drug Patent Profile

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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 is one drug master file entry 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:	5
Clinical Trials:	19
Patent Applications:	207
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
Cardinal Hlth 414	SODIUM IODIDE I 131	sodium iodide i-131	SOLUTION;ORAL	213615-001	Jun 12, 2025		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 Dynamics, Patent Landscape and Financial Trajectory

Last updated: October 15, 2026

Sodium iodide I-131 is a mature therapeutic radiopharmaceutical used mainly for thyroid ablation, treatment of differentiated thyroid cancer, and selected cases of hyperthyroidism. Its commercial outlook is driven by procedure volume, radioactive-isotope supply, nuclear-medicine capacity, reimbursement and radiopharmacy logistics rather than by conventional pharmaceutical patent protection.

The product has limited standalone revenue disclosure. Manufacturers and radiopharmacy operators generally report sales within broader nuclear medicine, radiopharmaceutical or medical-isotope categories. The market is therefore best analyzed through treatment demand, production capacity, isotope availability, regulatory barriers and pricing rather than through a single verified global revenue figure.

What is sodium iodide I-131 used for?

Sodium iodide I-131 is an oral radioactive iodine product. The iodine is selectively taken up by thyroid tissue, where beta radiation produces the therapeutic effect. The product is supplied as capsules or an oral solution, depending on the manufacturer and market.

The principal uses are:

• Remnant ablation after thyroidectomy for differentiated thyroid cancer.
• Treatment of iodine-avid metastatic or recurrent thyroid cancer.
• Treatment of Graves' disease and toxic nodular thyroid disease.
• Diagnostic or therapeutic thyroid procedures in specialized settings, although therapeutic use is the main commercial driver.

Iodine-131 has a physical half-life of approximately 8.02 days. That short half-life creates a supply chain in which manufacturing, quality release, shipment and administration must be coordinated closely.[1]

How large is the sodium iodide I-131 market?

No authoritative public source provides a clean, standalone global revenue figure for sodium iodide I-131. Market-research estimates differ substantially because some reports include all radioiodine products, thyroid procedures or radiopharmacy services, while others count only finished sodium iodide I-131 products.

The addressable market has several structural characteristics:

Market factor	Commercial effect
Thyroid cancer incidence	Supports recurring demand for ablation and metastatic disease treatment
Hyperthyroidism prevalence	Generates a large but lower-value treatment segment
Short isotope half-life	Limits inventory and increases delivery costs
Hospital nuclear-medicine capacity	Restricts administration volume
Reactor and processing capacity	Creates periodic supply constraints
Generic or multisource products	Limits price expansion
Reimbursement	Determines treatment-site economics
Radiation-safety rules	Raise operating and compliance costs

Demand is relatively defensive because treatment is clinically established and sodium iodide I-131 has no direct small-molecule substitute for many radioiodine-avid thyroid indications. Growth is more likely to come from procedure volume, geographic access and higher use in selected thyroid-cancer patients than from premium pricing.

What is the financial trajectory for sodium iodide I-131?

The financial trajectory is mature, volume-driven and operationally sensitive.

Near-term trajectory

Revenue should remain stable to moderately growing in markets with:

• Rising thyroid-cancer diagnosis and treatment volumes.
• Greater use of risk-adapted radioiodine therapy.
• Expansion of outpatient nuclear-medicine facilities.
• Improved access to therapeutic radiopharmaceuticals outside major academic hospitals.
• Continued treatment of Graves' disease and toxic nodular disease.

Price growth is constrained by generic-style competition, hospital procurement and the absence of meaningful exclusivity for the active radioactive ingredient.

Medium-term trajectory

The strongest commercial upside is likely to accrue to companies controlling isotope production, radiopharmacy distribution, high-throughput treatment centers or integrated thyroid-care networks. Finished-product manufacturers face a more limited opportunity because sodium iodide I-131 is relatively standardized and cannot be stored for long periods.

Revenue can decline temporarily when reactor outages, transport disruptions or regulatory shutdowns reduce supply. Because inventory loses activity rapidly, a supply interruption cannot be fully offset through stockpiling.

Long-term trajectory

The product is unlikely to become a high-growth branded pharmaceutical. Its long-term value is tied to:

1. Reliable isotope procurement.
2. Manufacturing and quality-control efficiency.
3. Distribution density.
4. Hospital and radiopharmacy contracts.
5. Access to thyroid-cancer and hyperthyroidism treatment centers.

Newer targeted radioligand therapies may compete for nuclear-medicine infrastructure and institutional budgets, but they do not directly replace sodium iodide I-131 in routine thyroid ablation or iodine-avid disease.

Which companies manufacture or distribute sodium iodide I-131?

The commercial landscape varies by country and by product presentation. Companies active in iodine-131 or adjacent nuclear-medicine supply have included:

• Curium, including legacy Mallinckrodt nuclear-medicine operations in some markets.
• Jubilant DraxImage.
• Cardinal Health nuclear and specialty-pharmacy operations.
• NorthStar Medical Radioisotopes, primarily through its broader isotope platform.
• Regional hospital radiopharmacies and contract nuclear pharmacies.
• National reactor and isotope suppliers that provide the underlying iodine-131 rather than the final administered product.

The value chain is fragmented. One company may produce or procure iodine-131, another may formulate and package the product, and a third may distribute it to a hospital or treatment center.

What is the FDA regulatory status of sodium iodide I-131?

Sodium iodide I-131 is an FDA-regulated radioactive drug. Approved products are subject to the normal requirements for drug quality, labeling, manufacturing and post-market safety, together with radiation-specific controls.

Relevant regulatory features include:

• NDA or abbreviated approval pathways for specific finished products.
• Radioactive-material handling requirements.
• Authorized-user and facility requirements under Nuclear Regulatory Commission or Agreement State rules.
• Dosimetry, radiation-safety and administration controls.
• Product-specific labeling for therapeutic indications and dosing.

The FDA regulates the drug product, while the Nuclear Regulatory Commission regulates many aspects of possession and medical use of radioactive material under 10 C.F.R. Part 35.[2] State radiation authorities may apply where an Agreement State program governs medical use.

FDA approval does not eliminate the operational barrier of obtaining a licensed facility, qualified personnel and compliant waste-management systems.

What is the Orange Book status of sodium iodide I-131?

The Orange Book position is commercially less important than it is for newer branded drugs. Sodium iodide I-131 is a mature product category, and the principal active ingredient is not protected by a modern composition-of-matter patent.

Orange Book analysis should be conducted at the specific NDA and dosage-form level because listings can differ by:

• Capsule versus oral solution.
• Product sponsor.
• Strength or activity range.
• Marketing status.
• Whether patents or exclusivity are listed for a particular approved product.

For the product category as a whole, there is no evident basis for a durable, category-wide Orange Book patent barrier. Any relevant listing would more likely concern a particular formulation, container, manufacturing process or use than the radioactive iodine active ingredient itself.[3]

What patents protect sodium iodide I-131?

The core sodium iodide I-131 product has weak patent protection compared with newly approved chemical or biologic medicines.

Active ingredient

The active therapeutic entity is radioactive iodine in the form of sodium iodide. The chemistry is longstanding, and the isotope's therapeutic use has been established for decades. Basic composition-of-matter protection is not a realistic commercial barrier.

Formulation patents

Potential formulation claims could cover:

• Capsule composition.
• Oral-solution excipients.
• Container and closure systems.
• Stability or activity-retention methods.
• Radiation-shielding packaging.
• Unit-dose preparation systems.

These claims are generally narrow. They may protect a particular commercial presentation but do not block competing sodium iodide I-131 products using a different formulation or package.

Method-of-use patents

Method-of-use claims could address:

• Patient selection based on thyroid-cancer risk.
• Dosimetry.
• Administration schedules.
• Combination treatment.
• Preparation for radioiodine therapy.

Such patents face challenges where the method reflects established clinical practice or standard guideline-based treatment. A method patent also may have limited enforcement value when hospitals use the product under physician-directed care.

Manufacturing and process IP

Manufacturing know-how can be more important than patents. Relevant assets include:

• Isotope procurement agreements.
• Reactor and irradiation access.
• Chemical processing.
• Sterile filling.
• Activity calibration.
• Release testing.
• Radiation-shielded packaging.
• Delivery routing and dispatch systems.

These capabilities can create a practical barrier even when the patent estate is weak.

How strong is the sodium iodide I-131 patent estate?

The patent estate is weak for the active ingredient and moderate for operational know-how.

IP category	Strength	Commercial relevance
Composition of matter	Low	Product is mature and chemically defined
Core therapeutic use	Low	Thyroid treatment uses are longstanding
Capsule or solution formulation	Low to moderate	May protect a specific presentation
Packaging and delivery	Moderate	Can support compliance and logistics
Manufacturing know-how	Moderate to strong	May limit reliable market entry
Facility and isotope access	Strong practical barrier	Often more important than patent rights
Brand and customer contracts	Moderate	Supports retention but does not block generic entry

The most defensible competitive position is usually supply reliability, not patent exclusivity.

When does sodium iodide I-131 lose exclusivity?

Sodium iodide I-131 does not have a single category-wide loss-of-exclusivity date comparable to a branded blockbuster. The underlying therapeutic technology has been available for decades, and competitive entry has occurred through multiple products, suppliers and radiopharmacy channels.

For a specific product, relevant dates may include:

• NDA approval date.
• Any listed patent expiration date.
• Regulatory exclusivity expiration.
• Discontinuation or marketing-status changes.
• Transfer of sponsorship or manufacturing.

Product-specific exclusivity must be checked against current FDA records rather than inferred from the maturity of the molecule. The commercial category itself is already post-exclusivity in practical terms.

Are there Paragraph IV challenges for sodium iodide I-131?

Paragraph IV litigation risk is limited and product-specific.

A generic applicant can challenge listed patents by certifying that a patent is invalid, unenforceable or will not be infringed. In sodium iodide I-131, the likely target would be a narrow patent covering a formulation, package or administration method rather than the active ingredient.

The commercial importance of a Paragraph IV case is also lower than in a conventional branded drug because:

• Multiple suppliers may already operate in the market.
• Hospital procurement can switch among approved products.
• Short product shelf life limits inventory strategy.
• A formulation patent may not prevent alternative presentations.
• Radiopharmacy infrastructure remains necessary after approval.

No category-wide patent litigation barrier is associated with sodium iodide I-131. Any meaningful case would need to be assessed against the specific NDA, patent listing and applicant.

What generic launch risks exist?

Generic or multisource entry is structurally feasible but operationally difficult.

Main entry risks

• Limited and variable demand by treatment center.
• Need for specialized radioactive-drug manufacturing.
• Short half-life and delivery constraints.
• High compliance costs.
• Dependence on licensed nuclear-medicine facilities.
• Reactor or isotope-supply interruptions.
• Limited ability to build inventory before launch.
• Hospital qualification and contracting requirements.

A new entrant may obtain regulatory approval yet fail to achieve scale if it lacks dependable dispatch capacity and customer density. Conversely, a company with an established nuclear-pharmacy network can enter more efficiently than a conventional generic-drug manufacturer.

Which companies are challenging the market?

Competition is less about patent challenges than about supply-chain position. The main competitive groups are:

1. Established nuclear-medicine manufacturers.
2. Integrated radiopharmacies.
3. Hospital-owned nuclear pharmacies.
4. Isotope producers and processors.
5. Specialty distributors.
6. New radiopharmaceutical companies using the same facilities for higher-value products.

The competitive threat to an existing sodium iodide I-131 supplier is usually a lower-cost or more reliable source, not a novel molecule.

What patent litigation affects sodium iodide I-131?

There is no widely recognized, category-defining patent litigation comparable to disputes involving major branded medicines. Litigation exposure is more likely to arise from:

• Product-specific formulation patents.
• Manufacturing or supply agreements.
• Regulatory exclusivity disputes.
• Trademark or labeling issues.
• Contract disputes between suppliers and radiopharmacies.
• Radiation-safety or facility compliance actions.

The absence of major patent litigation does not eliminate commercial risk. Supply disruption, product quality events and facility restrictions can have a faster financial effect than a patent case.

Is biosimilar risk relevant to sodium iodide I-131?

No. Biosimilar risk is not applicable because sodium iodide I-131 is a radioactive small-molecule drug, not a biologic. The relevant competitive categories are generic products, alternative suppliers, hospital compounding or preparation channels where legally permitted, and competing thyroid-treatment modalities.

How does sodium iodide I-131 compare with newer radiopharmaceuticals?

Attribute	Sodium iodide I-131	Newer targeted radioligand therapies
Primary use	Thyroid ablation, thyroid cancer, hyperthyroidism	Oncology or other receptor-targeted diseases
Product maturity	Decades	Often recently commercialized
Patent protection	Weak or expired core protection	Often strong composition and use patents
Pricing power	Low to moderate	Higher in many indications
Supply chain	Established but isotope-sensitive	More specialized and capacity-constrained
Administration	Oral in many cases	Often intravenous
Clinical substitution	Limited in thyroid indications	Limited to disease-specific alternatives
Revenue model	Volume and operational efficiency	Product exclusivity and treatment expansion

Newer radioligand therapies may generate higher revenue per patient, but sodium iodide I-131 remains difficult to displace in standard thyroid care because of its established efficacy, oral administration and broad clinical familiarity.

What geographic markets matter most?

The United States remains commercially important because of its large nuclear-medicine infrastructure, established reimbursement and extensive thyroid-care network. Europe and Japan also have mature radioiodine treatment systems, although product approvals, reimbursement and supply structures differ by country.

Growth opportunities are more pronounced in markets where:

• Thyroid cancer diagnosis is increasing.
• Nuclear-medicine facilities are expanding.
• Treatment is moving from centralized academic centers to regional hospitals.
• Isotope supply is being localized.
• Radiation-safety infrastructure is improving.

Geographic expansion is constrained by licensing, transport rules, local pharmacy standards and the ability to deliver product before significant radioactive decay.

Key Takeaways

• Sodium iodide I-131 is a mature therapeutic radiopharmaceutical with durable clinical demand.
• The principal uses are thyroid ablation, iodine-avid thyroid cancer and hyperthyroidism.
• Public sources do not provide a reliable standalone global revenue figure.
• Financial performance is driven by treatment volume, supply reliability, radiopharmacy density and reimbursement.
• The active ingredient has little meaningful modern patent protection.
• Formulation, packaging and manufacturing IP may protect specific products but are unlikely to create a broad market monopoly.
• Generic and multisource competition is commercially feasible, although isotope logistics and regulatory requirements restrict entry.
• Biosimilar risk does not apply.
• No category-wide patent litigation barrier defines the market.
• The strongest commercial moat is operational: isotope access, licensed facilities, quality systems, distribution and hospital contracts.

FAQs

Is sodium iodide I-131 a generic drug?

It is a mature multisource radioactive drug category. The regulatory status depends on the specific product and sponsor, but the category does not have the exclusivity profile of a newly launched branded medicine.

Does sodium iodide I-131 require special transportation?

Yes. The product is radioactive and must comply with applicable packaging, labeling, transport, radiation-safety and chain-of-custody requirements. The short half-life adds time pressure to every shipment.

Can sodium iodide I-131 be stockpiled?

Only to a limited extent. Its approximately 8-day physical half-life causes continuous loss of activity, making just-in-time manufacturing and delivery economically important.

Does iodine-131 compete with lutetium-177 radiopharmaceuticals?

They compete for some nuclear-medicine capacity and institutional budgets, but they generally treat different diseases. Lutetium-177 products do not broadly replace sodium iodide I-131 in thyroid ablation or standard radioiodine therapy.

What is the main investment risk in sodium iodide I-131?

The main risk is operational rather than patent-related. Reactor outages, isotope shortages, transportation interruptions, regulatory restrictions and insufficient treatment-center capacity can affect revenue more quickly than patent expiry.

References

1. International Atomic Energy Agency. (2022). Nuclear medicine resources manual. IAEA.

2. U.S. Nuclear Regulatory Commission. (2024). 10 C.F.R. Part 35: Medical use of byproduct material. https://www.nrc.gov

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files

4. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/

5. National Council on Radiation Protection and Measurements. (2019). Management of radionuclide therapy patients. NCRP.

6. Haugen, B. R., Alexander, E. K., Bible, K. C., et al. (2016). 2015 American Thyroid Association management guidelines for adult patients with thyroid nodules and differentiated thyroid cancer. Thyroid, 26(1), 1-133.