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Last Updated: March 19, 2026

IOSAT Drug Patent Profile


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When do Iosat patents expire, and what generic alternatives are available?

Iosat is a drug marketed by Anbex and is included in one NDA.

The generic ingredient in IOSAT is potassium iodide. There are two hundred and forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the potassium iodide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Iosat

A generic version of IOSAT was approved as potassium iodide by MISSION PHARMACAL on March 24th, 2016.

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Summary for IOSAT
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for IOSAT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Anbex IOSAT potassium iodide TABLET;ORAL 018664-002 May 12, 2011 OTC Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Anbex IOSAT potassium iodide TABLET;ORAL 018664-001 Oct 14, 1982 OTC Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Overview of IOSAT

Last updated: February 3, 2026

IOSAT is a trade name for potassium iodide (KI), used primarily as a protective agent against radioactive iodine exposure. It is approved by the U.S. Food and Drug Administration (FDA) and licensed for use as a thyroid blockade medication during radiological emergencies. The drug’s primary indication is to mitigate thyroid radiation uptake during nuclear incidents.

Market Landscape and Demand Drivers

  • Regulatory Mandate: U.S. government stockpiles IOSAT for emergency response; similar stockpiling efforts occur in countries with nuclear facilities.
  • Emergency Preparedness Market: The global market for nuclear incident countermeasures is growing, influenced by geopolitical tensions and aging nuclear infrastructure.
  • Pandemic and Biothreat Preparedness: Although primarily for radiation, heightened biosecurity awareness boosts interest in stockpiling medical countermeasures.

Manufacturing and Supply Chain

  • Production: IOSAT is produced by a limited number of pharmaceutical manufacturers, often as part of government contracts.
  • Pricing: The U.S. government procures IOSAT at competitive prices; retail prices vary, typically ranging from $15 to $30 per package.
  • Supply Risks: Dependency on few manufacturers underscores potential supply chain risks during peak demand or manufacturing disruptions.

Competitors and Alternatives

  • Other Iodine Tablets: SSKI (Saturated Solution of Potassium Iodide) and generic KI tablets serve similar functions.
  • Alternative Agents: No direct pharmacological substitutes for iodine blockade exist; however, other emergency countermeasures target different radiological threats.

Intellectual Property and Regulatory Status

  • Patents: Existing patents on potassium iodide formulations expired years ago, allowing generic manufacturing.
  • Regulatory Pathways: FDA approval under an investigational new drug (IND) mechanism; already approved for emergency use.

Financial and Investment Considerations

Aspect Details
Market Size The U.S. federal stockpile contains approximately 210 million doses (as of 2022), with regular replenishment cycles.
Revenue Streams Primarily from government contracts; retail and international sales are limited.
Growth Potential Moderate, driven by nuclear safety policies and emergency preparedness initiatives.
Competitive Edge Brand recognition through FDA approval and government stockpiles influences market stability; pricing is controlled via procurement contracts.

Regulatory and Political Environment

  • Moves to modernize emergency preparedness policies could affect demand.
  • Changes in nuclear policy or international treaties may influence procurement strategies.

Financial Outlook and Risks

  • Contract awards from the U.S. government and international agencies define revenue stability.
  • Supply chain disruptions can constrain availability.
  • New regulations or safety concerns, although unlikely, could impact manufacturing or stockpiling policies.

Key Takeaways

  • IOSAT’s market is primarily driven by government stockpiles and emergency preparedness policies.
  • Demand remains stable with incremental growth potential linked to nuclear safety concerns.
  • Manufacturing is concentrated; supply chain risks exist but are mitigated by stockpiling practices.
  • Competitive landscape remains limited due to regulatory barriers and patent expirations, favoring generic producers.
  • Investment prospects depend on policy developments and government procurement cycles.

FAQs

  1. What is IOSAT primarily used for?
    To protect the thyroid gland from radioactive iodine during nuclear incidents.

  2. Who are the main buyers of IOSAT?
    The U.S. government, international agencies, and emergency preparedness organizations.

  3. Are there patent restrictions on potassium iodide formulations?
    No, patents on potassium iodide expired years ago, enabling generic manufacturing.

  4. What factors could influence IOSAT’s market growth?
    Nuclear safety policies, international security concerns, and advances in emergency preparedness.

  5. What are the main risks to IOSAT investments?
    Supply chain disruptions, policy changes reducing stockpile requirements, and emerging alternatives or safety concerns.

Sources

[1] FDA. "Potassium Iodide (KI) Emergency Use Authorization." 2022.
[2] U.S. Department of Homeland Security. "Nuclear Preparedness and Response." 2022.
[3] MarketWatch. "Global Radiation Emergency Medical Countermeasures Market." 2022.
[4] Congressional Budget Office. "Nuclear Incident Readiness and Stockpiling." 2021.

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