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Last Updated: March 26, 2026

POTASSIUM IODIDE - Generic Drug Details


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Summary for POTASSIUM IODIDE
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SponsorPhase
National University of MalaysiaPHASE2
King Abdulaziz UniversityPHASE4
King Fahd Medical Research CentrePHASE4

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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
Btg Intl THYROSAFE potassium iodide TABLET;ORAL 076350-002 Apr 2, 2025 OTC No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Mission Pharmacal POTASSIUM IODIDE potassium iodide SOLUTION;ORAL 206211-001 Mar 24, 2016 OTC No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Anbex IOSAT potassium iodide TABLET;ORAL 018664-002 May 12, 2011 OTC Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Meda Pharms THYRO-BLOCK potassium iodide TABLET;ORAL 018307-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Anbex IOSAT potassium iodide TABLET;ORAL 018664-001 Oct 14, 1982 OTC Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Roxane POTASSIUM IODIDE potassium iodide SOLUTION;ORAL 018551-001 Feb 19, 1982 DISCN Yes 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

POTASSIUM IODIDE Market Analysis and Financial Projection

Last updated: February 14, 2026

What Are the Current Market Dynamics for Potassium Iodide?

Potassium iodide (KI) is primarily used as an anti-radiation agent and as a nutritional supplement to prevent iodine deficiency. The demand is driven by government stockpiling programs, nuclear event preparedness, and public health needs. The global potassium iodide market is growing steadily, with estimates projecting a compound annual growth rate (CAGR) of approximately 4-6% over the next five years.

What Are the Key Drivers of Market Growth?

Nuclear Safety Policies: Governments maintain stockpiles of potassium iodide as a protective measure against nuclear accidents. Countries like the U.S., Japan, and European nations have established policies for distribution during radiological emergencies.

Public Health Initiatives: Potassium iodide is included in national and global campaigns to address iodine deficiency disorders. These initiatives contribute to consistent demand, especially in regions with limited access to alternative iodine sources.

Pandemic and Emergency Preparedness: The increased focus on preparedness for unforeseen radiological events amplifies ongoing procurement contracts and inventory replenishment activities.

Market Segments: The commercial segment, featuring pharmaceutical manufacturers producing KI tablets, dominates supply. Currently, several firms hold significant market share, with the top three controlling approximately 60% of production capacity.

How Is the Supply Chain Structured and What Are Its Challenges?

Supply chains for potassium iodide involve raw material sourcing—primarily iodine derived from natural sources like seaweed or brine—followed by chemical synthesis, tablet manufacturing, packaging, and distribution. Industries face challenges such as raw material price volatility, regulatory compliance, and manufacturing capacity constraints.

The raw material iodine prices have escalated by approximately 20% over the past two years, influenced by disruptions in supply due to environmental regulations and global iodine demand from non-pharmaceutical sectors, notably LCD manufacturing.

Manufacturing bottlenecks occur mainly due to stringent regulatory approval processes in different jurisdictions, delaying new entrants and capacity expansion. Regulatory frameworks such as WHO and FDA requirements for Good Manufacturing Practices (GMP) necessitate substantial investment and operational adjustments.

What Is the Financial Trajectory of Market Players?

Leading manufacturers like Bracco, Amresco, and GlaxoSmithKline have reported steady revenue streams from potassium iodide products, with annual revenues ranging from $100 million to $250 million. Their profit margins hover around 15-20%, benefiting from the product's low-cost production and high regulatory barriers for new entrants.

Market prices for KI tablets have increased by 3-5% annually, aligned with raw material costs and inflation. Governments, as primary buyers, negotiate supply contracts averaging 5%, indicating moderate pricing power for large-scale procurements.

Fourth-quarter earnings of top manufacturers show continued investment in capacity expansion, with some firms anticipating up to 15% growth in production capacity over the next 24 months. These investments aim to address increasing demand driven by governmental stockpile policies and expanding emergency preparedness programs.

How Will Regulatory and Policy Changes Impact the Market?

Regulatory agencies are intensifying standards for pharmaceutical manufacturing and emergency authorization procedures. These developments can either create barriers for new entrants or streamline approval processes for existing products, impacting market competition and pricing.

The U.S. Food and Drug Administration (FDA) has maintained its stance that potassium iodide should be available within a 10-mile radius of nuclear facilities. Updates to these policies may stimulate local demand or influence stockpiling strategies.

The World Health Organization (WHO) recommends potassium iodide and other iodine supplements in regions with documented deficiencies. Variations in national policies can cause regional disparities in demand, affecting market stability.

What Is the Long-Term Outlook?

The potassium iodide market is expected to maintain moderate growth driven by ongoing nuclear risk concerns, continued public health use, and regulatory stability. Major players plan capacity expansions, suggesting sustained supply adequacy. However, shortages may occur if raw material costs or regulatory delays hinder manufacturing scalability.

Potential breakthroughs in alternative iodine delivery methods or shifts in nuclear safety policies could impact demand. Also, geopolitical instability in regions heavily reliant on imported iodine can disrupt supply lines, influencing market prices and availability.

Key Takeaways

  • The global potassium iodide market grows at 4-6% annually, driven by nuclear safety policies and public health needs.
  • Raw material costs and regulatory compliance serve as significant market constraints.
  • Leading firms report steady revenues with ongoing capacity investments to meet rising demand.
  • Policy changes and emergency preparedness strategies affect demand regionalization and market stability.
  • Market stability hinges on balancing raw material supply, regulatory environments, and government procurement policies.

FAQs

1. How does raw material iodine scarcity affect potassium iodide prices?
Raw iodine shortages can increase production costs for potassium iodide, leading to price increases in the supply chain. Environmental regulations and competing iodine demands also influence availability.

2. What are the primary regulatory hurdles for market expansion?
Compliance with GMP standards, approval processes from agencies like the FDA, and national stockpile policies create barriers that slow new entries and capacity growth.

3. How does government stockpiling impact market size?
Government procurement programs for emergency preparedness sustain high demand levels, stabilizing the market and providing predictable revenue streams for producers.

4. Are there any notable regional differences in market demand?
Yes. Countries with nuclear facilities or iodine deficiency issues, such as Japan, South Korea, and certain European nations, exhibit higher demand compared to regions with less nuclear infrastructure.

5. Could alternative delivery methods reduce dependence on potassium iodide?
Research into alternative iodine supplementation strategies exists but currently does not threaten the established market dominance of potassium iodide tablets in emergency scenarios.


References

[1] Market research reports, 2023.
[2] FDA guidelines, 2022.
[3] WHO iodine deficiency and supplementation guidelines, 2021.

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