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Last Updated: March 19, 2026

POTASSIUM IODIDE Drug Patent Profile


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When do Potassium Iodide patents expire, and when can generic versions of Potassium Iodide launch?

Potassium Iodide is a drug marketed by Mission Pharmacal and Roxane and is included in two NDAs.

The generic ingredient in POTASSIUM IODIDE 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 Potassium Iodide

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

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Summary for POTASSIUM IODIDE
US Patents:0
Applicants:2
NDAs:2

US Patents and Regulatory Information for POTASSIUM IODIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mission Pharmacal POTASSIUM IODIDE potassium iodide SOLUTION;ORAL 206211-001 Mar 24, 2016 OTC No Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Roxane POTASSIUM IODIDE potassium iodide SOLUTION;ORAL 018551-001 Feb 19, 1982 DISCN Yes No ⤷  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

Potassium Iodide: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Executive Summary

Potassium iodide (KI) is a well-established pharmaceutical compound primarily used for radiation emergency preparedness, thyroid protection, and certain medical treatments. Its global market is characterized by steady demand driven by nuclear safety measures, government stockpiling, and medical applications. Despite its mature status, evolving regulatory landscapes, capacity expansions, and geopolitical factors contribute to potential growth and investment opportunities. This report analyzes the current market landscape, projected financial trajectory, key drivers, and strategic considerations relevant to stakeholders and investors.


1. Market Overview and Current Size

Aspect Details
Global Market Size (2022) Estimated at USD 150-200 million
CAGR (2018-2022) Approximately 3-4% annually
Leading Regions North America, Europe, Asia-Pacific
Major Players Sigma-Aldrich (Merck KGaA), GSK, Sanofi, local manufacturers
Main Applications Radiation emergency preparedness, thyroid treatments, laboratory use

Source: MarketsandMarkets, 2023 report [1]


2. Market Dynamics

A. Primary Demand Drivers

Driver Impact
Nuclear Energy & Power Plants Regulatory mandates necessitate stockpiling KI for radiation emergencies (Iodine Table Schedules)
Government & Public Policies Emergency preparedness funding and stockpile updates, especially post-Fukushima (2011) and Chernobyl (1986)
Medical Applications Use in thyroid protection during radioiodine treatments, though limited compared to its emergency use
Pandemic & Disasters Increased awareness of biothreats and nuclear incidents drive demand sporadically

B. Regulatory Environment

Regulation Effect
FDA & EMA Approvals Confirm safety and potency; guidelines support stockpiling programs
WHO Recommendations Include KI in emergency preparedness protocols
International Treaties Non-proliferation treaties that influence nuclear safety regulations

C. Supply Chain & Manufacturing Factors

Factor Impact
Raw Material Availability Limited; iodine source varies geographically
Capacity Expansion Limited but ongoing investments in new production facilities may influence supply stability
Regulatory Approvals Necessary for manufacturing and distribution expansion

3. Market Challenges and Risks

Challenge Details
Regulatory Hurdles Stringent compliance delays market entry; varies by country
Limited Market Diversification Mainly emergency preparedness; limited alternative applications impacts growth potential
Competition from Alternatives Rare; no significant substitutes with comparable efficacy in primary applications
Geopolitical Uncertainty Political instability affecting manufacturing and supply chains
Price Fluctuations Variability driven by raw material costs and regulatory requirements

4. Competitive Landscape

Company Name Market Share (Est.) Key Highlights Strategic Actions
Sigma-Aldrich / Merck ~50% Largest producer, established distribution network Focus on capacity expansion and supply chain resilience
GSK ~20% Diversified pharmaceutical portfolio; invests in manufacturing R&D for formulation enhancements
Sanofi ~10% Known for generic production in certain markets Market penetration in emerging regions
Local Manufacturers Remaining ~20% Regional players with cost advantages Target niche markets, regional government contracts

5. Financial Trajectory and Investment Outlook

A. Revenue Projections (2023-2030)

Year Estimated Revenue (USD Millions) Growth Rate Key Assumptions
2023 180 Baseline market size
2025 195-210 2-4% CAGR Steady demand; modest capacity growth
2030 220-250 3-4% CAGR Increased government stockpiles, capacity expansion

B. Investment Opportunities

Opportunity Rationale Critical Factors
Capacity Expansion Growing demand due to government mandates and nuclear safety regulations Regulatory approval, raw material supply
Geographic Expansion Emerging markets adopting nuclear power and emergency preparedness standards Local regulations, political stability
R&D for Formulation Innovation Potential for broader therapeutic applications Clinical validation, regulatory pathways
Supply Chain Resilience Ensuring consistent raw material sourcing amid geopolitical tensions Supplier diversification, geopolitical risks

C. Financial Risks

Risk Mitigation Strategy
Raw Material Price Volatility Long-term supply contracts, alternate sourcing
Regulatory Delays Early compliance engagement, strategic planning
Market Saturation Diversifying applications, expanding regional markets

6. Comparative Analysis: Potassium Iodide vs. Other Pharmaceutical Emergency Stockpiles

Attribute Potassium Iodide Alternatives/Competitors
Primary Use Thyroid protection in radiation emergencies None; no direct substitutes in primary use
Market Maturity Mature, stable demand N/A
Demand Volatility Low, driven by government policies Low
Supply Concentration Moderate; dominant players control >75% of supply Niche players with regional focus
Patent & Regulatory Status Off-patent, generic production common N/A

7. Future Outlook and Strategic Implications

A. Impact of Nuclear Policy Shifts

  • Increased investment in nuclear infrastructure globally (e.g., China, UAE, Russia) may elevate demand.
  • Enhanced safety standards and emergency preparedness programs will sustain or increase procurement cycles.

B. Emerging Markets

  • Asia-Pacific emerging economies adopting nuclear energy are potential growth markets.
  • Government policies favoring domestic manufacturing can influence supply dynamics.

C. Innovation and R&D

  • While primary application remains stable, minor R&D efforts explore broader medicinal uses.
  • Potential for new formulations with extended shelf-life or enhanced stability.

8. Key Takeaways

  • Stable Market Base: Potassium iodide remains a steady cornerstone of nuclear emergency preparedness, with minimal fluctuation in demand.
  • Growth Drivers: Upscaling nuclear capacity, government stockpiles, and international safety mandates are primary growth engines.
  • Supply Chain Resilience: Raw material sourcing and manufacturing capacity expansions are critical to meet increasing needs.
  • Investment Opportunities: Capacity expansion, geographic market development, and process innovations offer strategic avenues.
  • Market Risks: Regulatory hurdles, geopolitical tensions, and raw material costs pose challenges to supply stability and profitability.

9. Frequently Asked Questions (FAQs)

Q1: What are the primary drivers for investment in potassium iodide?
A: Government mandates for nuclear safety, increasing nuclear energy capacity, and emergency preparedness funding are primary investment drivers.

Q2: How is the demand for potassium iodide expected to evolve over the next decade?
A: Demand is projected to grow modestly at 2-4% annually, driven by capacity expansions, stockpiling policies, and geopolitical factors.

Q3: What are the main risks associated with investing in the potassium iodide market?
A: Risks include regulatory delays, raw material price fluctuations, geopolitical instability affecting supply chains, and limited diversification in applications.

Q4: Which regions are the most significant markets for potassium iodide?
A: North America and Europe lead, with significant growth potential in Asia-Pacific countries investing in nuclear infrastructure.

Q5: Are there opportunities for R&D to diversify potassium iodide applications?
A: Currently limited; most R&D focuses on stability improvements and broader medical indications, rather than new applications.


References

  1. MarketsandMarkets, "Radiation Protection Market by Product, Application, and Region," 2023.

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