Last Updated: May 3, 2026

SODIUM IODIDE I 123 Drug Patent Profile


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Which patents cover Sodium Iodide I 123, 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 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-123 profile page.

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Summary for SODIUM IODIDE I 123
US Patents:0
Applicants:3
NDAs:4

US Patents and Regulatory Information for SODIUM IODIDE I 123

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
Ge Healthcare SODIUM IODIDE I 123 sodium iodide i-123 CAPSULE;ORAL 017630-003 Jan 8, 1993 DISCN No No ⤷  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 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 018671-002 May 27, 1982 AA RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Cardinal Health 418 SODIUM IODIDE I 123 sodium iodide i-123 CAPSULE;ORAL 018671-003 May 27, 1982 DISCN 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Sodium Iodide I 123: Investment Scenario and Fundamentals Analysis

Last updated: April 23, 2026

What is the asset and what is it used for?

Sodium Iodide I 123 is a radiopharmaceutical drug composed of sodium iodide labeled with iodine-123 (I-123). It is used for diagnostic nuclear medicine imaging that relies on iodine uptake and I-123 radiation.

In market and clinical practice, Sodium Iodide I 123 is primarily associated with:

  • Thyroid imaging (functional and anatomic assessment via nuclear imaging)
  • Use in thyroid uptake and scan workflows that support treatment planning in thyroid disorders

How does the value chain look for this radiopharmaceutical?

Radiopharmaceuticals like Sodium Iodide I 123 sit at the intersection of:

  1. Radioisotope supply
    • I-123 production capacity and logistics drive inventory availability and pricing pressure.
  2. Drug product manufacturing
    • Formulation and sterile preparation for injectable use.
  3. Distribution and administration
    • Tight logistics windows and imaging center scheduling affect sell-through and contract performance.
  4. Healthcare reimbursement
    • Imaging reimbursement rates and utilization patterns determine demand intensity.

This asset’s fundamentals are dominated by supply stability (isotope and manufacturing) and imaging utilization, more than by payer price-per-unit alone.

What are the demand drivers and how durable are they?

Demand for Sodium Iodide I 123 is linked to:

  • Thyroid disorder prevalence and repeat imaging cadence in clinical pathways
  • Ongoing use of nuclear medicine in thyroid evaluation and management
  • Practice patterns at hospitals and imaging centers that determine annual units purchased and schedules

Durability tends to be higher for:

  • Products embedded in established diagnostic algorithms
  • Facilities with dedicated nuclear medicine operations that maintain consistent purchase contracts

Demand tends to soften when:

  • Clinical practice shifts toward alternative imaging modalities (within thyroid diagnostics)
  • Supply interruptions constrain scheduling, which then reduces completed procedures

What is the competitive landscape and where is differentiation?

For radiopharmaceuticals, differentiation is less about formulation innovation and more about:

  • Supply reliability
  • Device and workflow compatibility
  • WAC-to-reimbursement alignment at the imaging center level
  • Regulatory compliance and lot-to-lot consistency

In many iodinated imaging agents, competition frequently occurs at the level of:

  • Available suppliers per market
  • Ability to meet demand without backorders
  • Contracting terms with distributors and health systems

How do patents and regulatory exclusivity typically shape the investment risk?

Sodium iodide I-123 is a radioisotope-labeled drug. In this category, value capture often depends less on classic small-molecule patent exclusivity and more on:

  • Drug product-specific rights (formulation, manufacturing method, labeling, or packaging)
  • Regulatory exclusivity (where applicable)
  • Market authorization and supply access that can persist across long periods if manufacturing is stable

For investment underwriting, the key risk is that regulatory or manufacturing exclusivity can be narrower and time-limited, while operational and isotope supply constraints can dominate near- to mid-term economics.

What is the underwriting framework for “fundamentals” here?

A practical fundamentals model for Sodium Iodide I 123 typically scores:

  1. Volume stability
    • Procedure counts, seasonality, and reorder behavior in imaging centers
  2. Pricing power
    • Ability to pass through supply-driven cost changes
  3. Supply continuity
    • Lead times, lot release performance, and ability to avoid missed schedules
  4. Working capital and cash conversion
    • Inventory turnover tied to short-lived radioisotopes and cold-chain constraints
  5. Regulatory throughput
    • Maintained approvals, facility compliance, and changes that can delay release

In radiopharmaceuticals, small variations in supply reliability can have outsized effects on realized demand.

What are the technical and operational considerations that affect outcomes?

Sodium Iodide I 123 is a diagnostic injectable radiopharmaceutical that requires:

  • Sterile preparation and quality system controls for patient safety
  • Precise activity measurement and labeling controls
  • Compliance with radiation safety and handling requirements at the point of care

Operational performance metrics that matter to investors and commercial teams include:

  • Lot release timelines
  • Activity accuracy and QC pass rates
  • Spoilage and discard risk from decay and distribution constraints
  • On-time delivery performance to nuclear medicine sites

What role does reimbursement play in unit economics?

The pricing of imaging radiopharmaceuticals is constrained by:

  • Payer reimbursement structures for imaging services
  • Packaged billing models at health systems
  • Contracting dynamics with group purchasing organizations and distributors

Even when WAC is stable, realized net pricing can shift due to:

  • Contract renewal cycles
  • Distributor margin changes
  • Service-line budgeting at hospitals

Key investment scenario: base case vs. risk case

Because Sodium Iodide I 123 is a diagnostic radiopharmaceutical, the highest-impact scenario drivers are supply and procedure utilization, not blockbuster sales growth.

Base case

  • Stable isotope availability and manufacturing throughput
  • Consistent procedure scheduling at nuclear medicine centers
  • Net pricing holds near contract averages
  • Continued authorization and no material regulatory disruption

Risk case

  • Isotope supply constraints tighten
  • Lot release delays occur or distribution windows widen
  • Procedure backlogs do not convert to future demand immediately
  • Net pricing increases do not fully offset volume loss

Market timing: what could shift the trajectory?

Trajectory shifts for this product usually come from:

  • Capacity changes in the I-123 supply chain
  • Regulatory actions affecting manufacturing or labeling
  • Large health system contracting changes that re-optimize imaging inventories
  • Clinical protocol shifts in thyroid imaging utilization

What should an investor watch in the next 12 to 36 months?

High-signal indicators:

  • Announcements of I-123 supply capacity changes (production, transport, or allocation)
  • Manufacturing site inspection outcomes and any corrective action plans
  • Evidence of procedure volume changes in thyroid imaging services
  • Contract wins or losses with major distribution partners and health systems
  • Formulary adoption signals in nuclear medicine service lines

Valuation logic: how to think about returns

For a diagnostic radiopharmaceutical, returns typically come from:

  • Sustained unit volumes
  • Controlled cost of goods and logistics
  • Reduced working capital strain from improved supply planning
  • Stable reimbursement economics for imaging services

The investment “edge” is often operational:

  • Better ability to secure isotope supply
  • Faster lot release and delivery execution
  • Efficient allocation strategy across facilities

What are the most material fundamentals to diligence (checklist)

  • Isotope supply commitments: allocation policies, lead times, and contingency supply
  • Manufacturing reliability: QC pass rates, sterility assurance controls, historic release timeliness
  • Distribution performance: on-time delivery and discard/decay loss rates
  • Net pricing history: contract coverage, rebates, distributor margins, and realized ASP trends
  • Utilization metrics: thyroid scan volumes by region and facility type
  • Regulatory stability: changes to labeling, manufacturing changes, and inspection outcomes

Key Takeaways

  • Sodium Iodide I 123 is a diagnostic radiopharmaceutical whose value is driven by isotope supply reliability and thyroid imaging utilization, not by patent-style blockbuster expansion.
  • Fundamentals underwriting should prioritize lot release execution, working capital/decay risk, and net pricing stability under distributor and health system contracting.
  • The highest volatility risk is supply allocation and logistics timing, which can suppress completed imaging procedures and delay demand recovery.
  • The highest return upside comes from operational execution advantages: stable I-123 access, consistent manufacturing performance, and dependable delivery into nuclear medicine schedules.

FAQs

1) What is Sodium Iodide I 123 used for?

It is used for diagnostic thyroid imaging and related thyroid uptake and scan workflows in nuclear medicine.

2) What drives sales more than anything else?

For this asset class, the dominant drivers are procedure volume and supply continuity of I-123, plus the ability to deliver on schedule to imaging centers.

3) Does this product behave like a typical small-molecule drug?

No. Its economics are shaped by radiopharmaceutical operational constraints (decay, QC release, cold-chain logistics) and isotope supply dynamics.

4) What is the main investment risk?

Supply interruption or allocation constraints that reduce completed imaging procedures, combined with logistics-driven working capital strain.

5) Where does differentiation usually come from?

Differentiation is operational: reliability of supply, manufacturing consistency, and distribution performance more than formulation innovation.


References

[1] U.S. Food and Drug Administration. Labeling for Sodium Iodide I-123 (drug product information and prescribing information). FDA Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] U.S. National Library of Medicine. Sodium Iodide I-123. PubChem. https://pubchem.ncbi.nlm.nih.gov/
[3] American College of Radiology. Nuclear medicine practice information and diagnostic imaging context (thyroid imaging overview). ACR. https://www.acr.org/

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