Last Updated: June 25, 2026

SODIUM IODIDE I 123 Drug Patent Profile


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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 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
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 1
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

SponsorPhase
National University of MalaysiaPHASE2
Stryker EndoscopyPhase 4
University Health Network, TorontoPhase 4

See all SODIUM IODIDE I 123 clinical trials

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
>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: Market Dynamics and Financial Trajectory

Last updated: April 23, 2026

What market does sodium iodide I 123 address?

Sodium Iodide I 123 (I-123) is a radiopharmaceutical used primarily for thyroid imaging. It is prescribed for diagnostic nuclear medicine procedures that rely on iodine uptake by the thyroid, with protocols typically involving in-vivo imaging rather than chronic disease management.

The market is shaped by four structural realities:

  1. Supply chain and licensing constraints

    • I-123 production depends on upstream isotope supply and regulated distribution.
    • Commercial availability is constrained by radionuclide availability windows and production campaigns rather than routine chemical manufacturing economics.
  2. Regulatory and procurement behavior

    • Hospitals and imaging centers procure radiopharmaceuticals via regulated channels with tendering, formulary inclusion, and reliance on stable vendor performance (delivery reliability matters more than brand advertising).
  3. Geographic reimbursement differences

    • Revenue per imaging procedure varies by country due to reimbursement rules for nuclear medicine scans and facility billing structures.
  4. Procedure demand is tied to diagnostic volumes

    • Usage correlates with thyroid disease evaluation rates and nuclear medicine utilization trends, which tend to be steadier than oncology-driven demand but still fluctuate with healthcare utilization levels.

How does pricing typically behave in this segment?

Radiopharmaceutical economics differ from conventional drugs:

  • Pricing tracks logistics and isotope scarcity more than generic competition. I-123 is not “competed away” by copy products in the way small-molecule generics are.
  • Per-dose acquisition costs dominate. Most purchasing decisions are dose-count and expiration-cycle driven (radiopharmaceutical wastage is a direct cost).
  • Contracting and distribution margins matter. The installed base of logistics providers and distribution lanes influences the delivered cost more than list price dynamics.

What supply drivers affect sodium iodide I 123 availability?

Key drivers that influence market supply and pricing power include:

  • Isotope production capacity for I-123
  • Radionuclide production schedules and yield
  • Regulatory release and batch acceptance cycles
  • Shelf-life and distribution timing
  • Concentration of manufacturing capacity among limited suppliers

These factors can create periods of tight availability where pricing and allocation constraints tighten margins for manufacturers and distributors, then normalize when supply stabilizes.

Who are the key market participants?

The market for I-123 is characterized by a limited set of radiopharmaceutical suppliers and nuclear medicine distributors. The competitive set is typically defined by:

  • Radiopharmaceutical manufacturers producing I-123 sodium iodide formulations
  • Regional distributors and imaging supply chains that secure allocation

In practice, brand-level differentiation is less important than:

  • Compliance track record
  • Dose availability
  • Delivery reliability
  • Batch consistency

What are the regulatory and exclusivity anchors that shape financial trajectory?

For radiopharmaceuticals, financial trajectory is usually determined by the interplay of:

  • Marketing authorization status (or equivalent regulatory approvals in each jurisdiction)
  • Manufacturing compliance and validated release methods
  • Supplier continuity
  • Any patent or exclusivity around manufacturing methods, formulation, or process

Market stability is often better than for commodity generics, because the product is inherently hard to source and must meet radiation-handling and release standards each batch.

What is the financial trajectory pattern for I-123 products?

The typical trajectory for a mature radiopharmaceutical looks like this:

  1. Launch or re-authorization phase

    • Higher margins can occur when supply is constrained and conversion to the validated commercial supply is limited.
  2. Maturity phase

    • Margins normalize as supply becomes routine and procurement contracts lock in pricing.
  3. Tight supply shocks

    • When upstream isotope supply tightens, allocation can lift pricing and improve manufacturer revenue per sale, though it can also increase operational cost and reduce conversion-to-use due to wastage risk.
  4. Exit risk and manufacturing continuity

    • If suppliers face regulatory or production disruptions, short-term revenue can shift to surviving suppliers, and higher distributor costs can persist.

Net effect: revenue tends to be “volume-plus-availability” rather than pure growth from utilization alone. Growth opportunities usually come from expanding access within nuclear medicine networks and securing stable supply contracts.

What demand levers drive growth?

Demand for sodium iodide I 123 is tied to nuclear medicine usage patterns. Growth levers include:

  • Increased diagnostic utilization
    • Higher imaging volumes from thyroid evaluation programs.
  • Imaging protocol shifts
    • Some centers change the preferred iodine isotope based on imaging targets, workflow, and availability.
  • Geographic expansion of nuclear medicine capacity
    • Growth in imaging sites increases procedure frequency.
  • Operational efficiencies
    • Lower wastage rates through better scheduling and dose planning supports throughput.

Offsetting factors can include:

  • Reimbursement compression
  • Imaging mix shifts (for example, protocol preference moving to alternative tracers in some regions)
  • Healthcare budget constraints

What are the primary risks to revenue?

Radiopharmaceutical financial performance is exposed to a narrower set of but high-impact risks:

  • Isotope supply disruptions
  • Batch rejection or release delays
  • Regulatory enforcement or manufacturing interruptions
  • Contract losses to alternate suppliers
  • Demand softness from broader healthcare utilization declines
  • Wastage due to expiration
    • Even with stable procedure volumes, mismatch between delivery cycles and scheduling can reduce effective doses sold.

How does a “switching-cost” dynamic influence competitive positioning?

For nuclear medicine providers, switching suppliers carries friction:

  • Operational training and standardization
    • Facilities calibrate workflows around delivery reliability and packaging.
  • Quality assurance and acceptance testing
  • Inventory and scheduling integration
  • Regulatory documentation
    • Procurement decisions tie into quality systems.

This gives incumbent suppliers a stability advantage, especially during tight supply periods.

What does that imply for financial upside and downside?

Upside

  • Tight upstream I-123 availability can raise realized revenue per delivered dose, and improve allocation-related revenue capture.
  • Long-term supply contracts can protect throughput and stabilize cash conversion.

Downside

  • Demand shocks can hit quickly due to expiration and operational fragility.
  • Supplier outages can cause procurement to shift temporarily or permanently, depending on how quickly alternative sourcing is validated.

Comparable dynamics across radiopharmaceuticals

While sodium iodide I 123 is specific, the market behavior mirrors the broader radionuclide segment:

  • Revenue is often more sensitive to supply continuity than to marketing.
  • Financial performance can swing with isotope availability windows.
  • The competitive edge is reliability and regulatory track record.

Bottom-line market dynamics summary

  • Market is demand-inelastic at the therapy level because I-123 is diagnostic and tied to imaging workflows.
  • Pricing power is episodic, driven by upstream isotope tightness.
  • Financial trajectory is supply-and-contract driven, with “availability shocks” dominating year-over-year variability.

Key Takeaways

  • Sodium iodide I 123 is a thyroid imaging radiopharmaceutical; its market behaves like a regulated isotope-driven supply business rather than a generic pharmaceutical category.
  • Pricing and revenue are dominated by dose availability, batch release timing, and wastage risk, not by conventional brand competition.
  • Financial trajectory is typically stable in mature markets but can show sharp swings during I-123 supply tightness or manufacturing continuity disruptions.
  • Competitive advantage rests on reliable supply and contracting, which reduces hospital switching during procurement cycles.

FAQs

1) Is sodium iodide I 123 a growth product like oncology drugs?

No. It is a diagnostic imaging radiopharmaceutical, so growth follows diagnostic imaging utilization and supply continuity rather than progressive disease treatment uptake.

2) What drives realized revenue: dose volume or price?

Both matter, but in practice dose availability and delivery reliability often dominate realized revenue because radiopharmaceutical procurement depends on whether doses arrive and are usable within shelf-life windows.

3) Do generic manufacturers pressure margins for I-123?

Not in the same way as small-molecule generics. The constraint is regulated manufacture, radionuclide supply, and validated release, which limits straightforward “copy competition.”

4) What is the biggest financial risk?

Upstream I-123 isotope supply disruptions or manufacturing release delays, which can reduce usable doses and disrupt procurement contracts.

5) How do hospitals typically decide which supplier to use?

On delivered reliability, batch consistency, regulatory acceptance, and contract pricing terms, with logistics and scheduling integration as major determinants.


References

  1. U.S. Food and Drug Administration (FDA). Drug Labeling for sodium iodide I 123 (radiopharmaceutical) products. https://www.accessdata.fda.gov/scripts/cder/daf/

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