SODIUM IODIDE I 123 Drug Patent Profile
When do Sodium Iodide I 123 patents expire, 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 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-123 profile page.
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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 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 6 |
| Clinical Trials: | 19 |
| Patent Applications: | 82 |
| What excipients (inactive ingredients) are in SODIUM IODIDE I 123? | SODIUM IODIDE I 123 excipients list |
| DailyMed Link: | SODIUM IODIDE I 123 at DailyMed |
Recent Clinical Trials for SODIUM IODIDE I 123
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 |
US Patents and Regulatory Information for SODIUM IODIDE I 123
Sodium Iodide I-123 Market Dynamics, Financial Trajectory, FDA Status, and Patent Outlook
Sodium iodide I-123 is an established diagnostic radiopharmaceutical used primarily for thyroid imaging and radioactive iodine uptake testing. Its commercial market is mature, fragmented, and supply-chain driven. Revenue growth depends more on procedure volumes, isotope availability, hospital nuclear-medicine capacity, and distributor coverage than on patent exclusivity.
No meaningful composition-of-matter patent barrier protects sodium iodide I-123. The product has no conventional brand-driven pricing model, and public companies generally do not report product-level revenue. Financial performance is therefore best assessed through demand for thyroid diagnostics, radiopharmaceutical distribution, and production reliability.
What is sodium iodide I-123 used for?
Sodium iodide I-123 is an orally administered diagnostic radiopharmaceutical containing radioactive iodine-123. The thyroid selectively takes up iodine, allowing nuclear-medicine physicians to evaluate thyroid anatomy and function.
| Attribute | Sodium iodide I-123 |
|---|---|
| Active isotope | Iodine-123 |
| Chemical form | Sodium iodide |
| Primary route | Oral capsule or oral solution |
| Principal use | Thyroid imaging and radioactive iodine uptake |
| Physical half-life | Approximately 13.2 hours |
| Principal gamma energy | Approximately 159 keV |
| Radiation type used for imaging | Gamma emission |
| Therapeutic or diagnostic | Diagnostic |
| Main clinical setting | Nuclear medicine departments and outpatient imaging centers |
| FDA status | Prescription diagnostic radiopharmaceutical |
| Patent profile | No meaningful active molecule patent barrier |
The short half-life reduces radiation exposure compared with iodine-131 and makes I-123 suitable for imaging. It also creates a demanding commercial model: doses must be manufactured, quality tested, shipped, received, and administered within a narrow time window.
The FDA label identifies thyroid imaging and radioactive iodine uptake testing as the principal uses. The product is not interchangeable with therapeutic iodine-131, which emits beta radiation and is used for treatment of thyroid disease and thyroid cancer (U.S. Food and Drug Administration [FDA], n.d.-a).
What is the FDA regulatory status of sodium iodide I-123?
Sodium iodide I-123 is an FDA-approved diagnostic radiopharmaceutical sold under product descriptions that identify the isotope and dosage form rather than a major consumer brand. FDA-approved presentations have included capsules and other oral dosage forms supplied through radiopharmaceutical manufacturers and nuclear pharmacies.
FDA regulation covers:
- Drug approval and labeling.
- Current good manufacturing practice.
- Radioactive-material handling.
- Dosimetry and expiration dating.
- Packaging and shipping.
- State and federal licensing for radioactive materials.
- Nuclear pharmacy preparation and distribution.
The product is generally dispensed by prescription and administered under the supervision of qualified nuclear-medicine personnel. Facilities must comply with applicable Nuclear Regulatory Commission or Agreement State requirements in addition to FDA requirements (Nuclear Regulatory Commission, n.d.).
What is the Orange Book status of sodium iodide I-123?
Sodium iodide I-123 is an FDA-approved drug product, but it does not have the commercial profile of a conventional small-molecule brand with a prominent Orange Book patent estate. The market is supplied through approved radiopharmaceutical products and licensed nuclear pharmacies rather than through one dominant branded product.
No commercially important patent listing is generally associated with the sodium iodide I-123 active ingredient itself. Any Orange Book relevance would attach to a specific approved product, formulation, or delivery presentation rather than to iodine-123 as a chemical entity. The FDA Orange Book remains the controlling source for product-specific patent and exclusivity listings (FDA, n.d.-b).
When does sodium iodide I-123 lose exclusivity?
Sodium iodide I-123 has effectively lost any conventional market exclusivity associated with its original approval. The active ingredient is an established isotope and salt, and the core diagnostic use is long-standing.
| Exclusivity category | Commercial position |
|---|---|
| New chemical entity exclusivity | Expired or not applicable to the mature product |
| Orphan-drug exclusivity | Not generally applicable |
| Pediatric exclusivity | No material market impact identified |
| Composition patent | No active barrier of commercial significance |
| Formulation patent | Limited commercial relevance |
| Method-of-use patent | No dominant enforceable use patent identified |
| Regulatory exclusivity | Mature product; no meaningful exclusivity barrier |
| Generic or multisource competition | Established |
The main barriers are operational rather than legal. A new supplier must obtain regulatory approval, qualify isotope production, demonstrate product quality, establish radioactive-material licenses, and build a delivery network capable of meeting same-day or next-day demand.
How many patents cover sodium iodide I-123?
The core product has little patent protection. Iodine-123 is a known radionuclide, and sodium iodide is a long-established chemical form. Patents may arise around:
- Production methods for radioisotopes.
- Target materials and cyclotron processes.
- Purification and radionuclidic separation.
- Automated dispensing systems.
- Dosage calibration and packaging.
- Imaging protocols or combination procedures.
- Specific diagnostic devices.
These patents generally do not prevent competition in the basic sodium iodide I-123 product. A production patent could affect manufacturing economics or supply access, but it would not create a durable product monopoly comparable with a patented therapeutic drug.
What formulations are protected by sodium iodide I-123 patents?
No widely recognized patent estate protects the basic sodium iodide I-123 capsule as a commercially differentiated formulation. Capsules, oral solutions, and unit-dose packaging are technically straightforward relative to complex injectable or targeted radiopharmaceutical products.
Potentially protectable features include:
- Stabilizers.
- Capsule composition.
- Radiation-resistant packaging.
- Calibration systems.
- Unit-dose dispensing methods.
- Automated production and quality-control processes.
Such rights would be formulation- or process-specific. They would not normally block a competing manufacturer from supplying sodium iodide I-123 in a different approved presentation.
What is the market size and commercial structure for sodium iodide I-123?
Sodium iodide I-123 is a niche product within the broader nuclear-medicine market. Public market reports commonly aggregate I-123 with thyroid imaging agents, diagnostic radiopharmaceuticals, or the wider radiopharmaceutical industry. They generally do not disclose audited revenue for sodium iodide I-123 alone.
The commercial chain is:
- Isotope production by a cyclotron or specialized radiopharmaceutical manufacturer.
- Chemical conversion into sodium iodide I-123.
- Quality control and dose calibration.
- Distribution through a radiopharmaceutical wholesaler or nuclear pharmacy.
- Administration at a hospital or outpatient imaging center.
Key suppliers and distribution channels have included large nuclear-medicine organizations such as Cardinal Health, Curium, Jubilant Radiopharma, and other regional radiopharmaceutical providers. Supplier participation varies by country and presentation. Product-level market share is not publicly reported.
What drives revenue for sodium iodide I-123?
Revenue is primarily a function of dose volume and reimbursement per study.
| Revenue driver | Effect on sodium iodide I-123 |
|---|---|
| Thyroid imaging volume | Direct positive effect |
| Thyroid uptake testing | Direct positive effect |
| Nuclear-medicine department capacity | Determines available procedures |
| Isotope availability | Can constrain or expand sales |
| Cyclotron proximity | Affects delivery radius and waste |
| Dose wastage | Reduces realized margin |
| Reimbursement | Determines provider willingness to use the product |
| Competition from ultrasound and CT | Can reduce use in selected cases |
| Competition from I-131 and Tc-99m | Creates substitution pressure |
| Supplier reliability | Influences hospital purchasing decisions |
The product has a high value-to-volume ratio but a short commercial shelf life. Unsold inventory can lose value rapidly as radioactivity decays. This limits the ability to hold inventory and shifts bargaining power toward suppliers with reliable production and distribution.
What is the financial trajectory for sodium iodide I-123?
The financial trajectory is mature and relatively stable, with modest growth potential. Product revenue is unlikely to show the sharp expansion associated with innovative oncology radiopharmaceuticals, peptide receptor radionuclide therapies, or prostate-specific membrane antigen agents.
Base-case trajectory
The likely base case is low-single-digit nominal growth driven by:
- Stable thyroid-imaging demand.
- Replacement of aging nuclear-medicine equipment.
- Expansion of outpatient imaging centers.
- Improved scheduling and dose utilization.
- Population growth and continued diagnosis of thyroid disorders.
Upside case
Growth could exceed the broader diagnostic market if:
- More centers restore or expand nuclear-medicine services.
- Supply reliability improves in underserved regions.
- Clinical protocols favor I-123 over higher-dose alternatives.
- Reimbursement supports uptake testing and functional imaging.
- Suppliers reduce product wastage through better production scheduling.
Downside case
Revenue could decline if:
- Thyroid imaging shifts toward ultrasound, CT, or other modalities.
- Hospitals reduce low-volume nuclear-medicine services.
- Isotope shortages interrupt procedures.
- Reimbursement pressure reduces use of dedicated uptake studies.
- Suppliers consolidate and rationalize low-volume routes.
- I-123 is replaced by other diagnostic agents in selected protocols.
A product-level revenue forecast cannot be derived from public filings because major suppliers generally report nuclear medicine, pharmaceutical distribution, or diagnostic segments rather than sodium iodide I-123 separately.
How does sodium iodide I-123 compare with competing thyroid imaging agents?
| Product | Main role | Advantage over I-123 | Limitation relative to I-123 |
|---|---|---|---|
| Sodium iodide I-123 | Thyroid imaging and uptake | Direct physiologic iodine uptake; favorable imaging profile | Short half-life and specialized supply chain |
| Iodine-131 sodium iodide | Therapy and selected diagnostic uses | Broad availability in some markets; therapeutic utility | Higher radiation burden and poorer imaging characteristics |
| Technetium-99m pertechnetate | Thyroid imaging | Broad nuclear-medicine availability; lower logistical burden | Does not follow iodine organification in the same manner |
| Ultrasound | Structural thyroid imaging | Widely available; no radiation | Does not provide equivalent functional uptake data |
| CT or MRI | Structural or staging information | Anatomic detail | Not a direct substitute for thyroid uptake measurement |
| PET agents | Selected oncology and inflammatory indications | High sensitivity for certain disease settings | Higher cost and limited relevance for routine thyroid uptake |
I-123 remains differentiated when clinicians need functional information about iodine uptake, thyroid tissue, or nodules. Ultrasound is a frequent complement rather than a complete replacement.
Which companies are challenging the sodium iodide I-123 market?
Competition is primarily commercial rather than patent-based. Suppliers compete on:
- Dose availability.
- Delivery time.
- Geographic coverage.
- Price per millicurie or unit dose.
- Expiration dating.
- Order flexibility.
- Nuclear pharmacy integration.
- Reliability during isotope shortages.
Relevant supplier groups include Cardinal Health Nuclear & Precision Health Solutions, Curium, Jubilant Radiopharma, and regional hospital-based or independent nuclear pharmacies. The competitive structure varies by geography because radioactive products cannot be distributed over the same distances as conventional tablets.
No major Paragraph IV campaign is associated with the mature sodium iodide I-123 market. A competitor could seek approval under an abbreviated or alternative regulatory pathway where applicable, but the absence of meaningful active product patents reduces the strategic value of a patent challenge.
What patent litigation and settlement agreements affect sodium iodide I-123?
No major ongoing patent litigation or settlement agreement is broadly associated with the core sodium iodide I-123 product. The market lacks the typical litigation pattern seen in high-revenue branded drugs with multiple Orange Book-listed patents.
Potential disputes would more likely involve:
- Manufacturing know-how.
- Supply contracts.
- Radioisotope production technology.
- Regulatory compliance.
- Distribution territories.
- Product liability.
- Trade secrets.
- Facility licensing.
These issues could affect supply or operating costs without changing the legal availability of the active product.
What generic launch risks exist for sodium iodide I-123?
A conventional generic launch would face limited patent risk but substantial execution risk.
Regulatory risk
The applicant must demonstrate that the product meets identity, strength, purity, sterility where applicable, radionuclidic purity, chemical purity, expiration dating, and labeling requirements. Radioactive decay complicates stability testing and batch release.
Manufacturing risk
I-123 production requires access to suitable cyclotron capacity, enriched target material, validated purification, and reliable quality-control systems. The short half-life increases the cost of failed batches and delayed release.
Distribution risk
A supplier needs qualified shipping containers, radioactive-material licenses, trained personnel, and a regional delivery network. A product can be technically approved but commercially weak if it cannot reach hospitals within the usable activity window.
Pricing risk
Because the product is mature and generally multisource, price competition can compress margins. Suppliers with established nuclear-pharmacy infrastructure may have a cost advantage over a new entrant.
What manufacturing and geographic barriers protect incumbent suppliers?
Manufacturing and geographic barriers are more important than patents.
| Barrier | Commercial impact |
|---|---|
| Cyclotron access | Limits production capacity |
| Enriched target supply | Can constrain isotope economics |
| Radioactive-material licensing | Raises entry time and compliance costs |
| Short half-life | Restricts shipping radius |
| Nuclear pharmacy network | Determines hospital access |
| Quality-control release | Can delay dispatch |
| Specialized personnel | Limits operational scalability |
| Route density | Determines delivery profitability |
| Waste and failed-batch risk | Reduces gross margin |
| Emergency supply capability | Supports hospital contracts |
The market naturally favors regional networks. A supplier with a nearby production site can often compete against a larger national organization if it offers dependable delivery and lower decay-related waste.
What is the biosimilar risk for sodium iodide I-123?
There is no biosimilar risk. Sodium iodide I-123 is a small-molecule radioactive drug, not a biologic. Competition comes from multisource radiopharmaceutical products, alternative isotopes, imaging modalities, and supplier substitution.
The relevant commercial risk is generic and product substitution, not biosimilar erosion.
What is the outlook for investors and pharmaceutical companies?
Sodium iodide I-123 is more attractive as part of a radiopharmaceutical platform than as a standalone growth asset. Its predictable clinical role can support recurring revenue, but its mature market limits pricing power and margin expansion.
Positive indicators
- Established FDA-approved diagnostic use.
- Persistent need for thyroid functional imaging.
- Limited patent erosion risk because the product is already mature.
- Repeat hospital and imaging-center demand.
- Potential margin gains from better dose planning and route density.
Negative indicators
- Limited product differentiation.
- No durable exclusivity.
- Product-level revenue opacity.
- Short shelf life.
- Exposure to facility shutdowns and isotope shortages.
- Substitution by ultrasound, Tc-99m, and other diagnostic approaches.
- High operational requirements relative to product value.
The strongest commercial position belongs to suppliers that combine isotope production, regulatory capability, nuclear pharmacy operations, and dense regional distribution.
Key Takeaways
- Sodium iodide I-123 is a mature diagnostic radiopharmaceutical used mainly for thyroid imaging and radioactive iodine uptake testing.
- Its physical half-life is approximately 13.2 hours, making supply reliability and geographic proximity central commercial factors.
- The active ingredient has no meaningful composition patent barrier or durable market exclusivity.
- No major Paragraph IV challenge, patent litigation campaign, or settlement agreement defines the market.
- Product-level revenue is not publicly disclosed by major suppliers.
- Financial growth is likely to be modest and linked to procedure volumes, reimbursement, outpatient nuclear-medicine capacity, and isotope availability.
- Manufacturing, radioactive-material licensing, quality control, and distribution are stronger barriers to entry than patents.
- There is no biosimilar risk; the principal risks are generic competition, alternative imaging, and supply-chain disruption.
- Sodium iodide I-123 is more valuable as part of an integrated nuclear-medicine platform than as a standalone high-growth pharmaceutical asset.
FAQs
Is sodium iodide I-123 a generic drug?
It is a mature multisource diagnostic radiopharmaceutical rather than a conventional branded-generic product. Competition is based on approved products, supply reliability, and distribution coverage.
Is sodium iodide I-123 the same as radioactive iodine treatment?
No. I-123 is primarily used for imaging and diagnostic uptake testing. I-131 is commonly used for radioactive iodine treatment because it emits therapeutic beta radiation.
Can hospitals substitute technetium-99m for sodium iodide I-123?
Technetium-99m pertechnetate can substitute in selected thyroid imaging protocols, but it does not reproduce all aspects of iodine uptake and organification. Clinical substitution depends on the diagnostic question and physician protocol.
Why is sodium iodide I-123 expensive despite having no patent protection?
The cost reflects isotope production, radioactive-material compliance, quality-control testing, specialized packaging, dose calibration, rapid delivery, and product loss from radioactive decay.
Does sodium iodide I-123 have long-term growth potential?
Its standalone growth potential is limited. The better growth opportunity is within broader nuclear-medicine platforms that combine diagnostic isotopes, hospital distribution, nuclear pharmacies, and newer targeted radiopharmaceuticals.
References
- U.S. Food and Drug Administration. (n.d.-a). Sodium iodide I-123 prescribing information. https://www.accessdata.fda.gov
- U.S. Food and Drug Administration. (n.d.-b). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book
- National Nuclear Data Center. (n.d.). NuDat 3: Nuclear structure and decay data for iodine-123. Brookhaven National Laboratory. https://www.nndc.bnl.gov/nudat/
- International Atomic Energy Agency. (n.d.). Cyclotron produced radionuclides: Physical characteristics and production methods. https://www.iaea.org
- U.S. Nuclear Regulatory Commission. (n.d.). Medical use of radioactive materials. https://www.nrc.gov/materials/miau/med-use.html
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