Generic POTASSIUM IODIDE INN equivalents, drug patent expiration information and freedom to operate

Sponsor	Phase
National University of Malaysia	PHASE2
King Abdulaziz University	PHASE4
King Fahd Medical Research Centre	PHASE4

Subscribe to access the full database, or Start Trial
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	076350-001	Sep 10, 2002		OTC	No	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Arco Pharms Llc	THYROSHIELD	potassium iodide	SOLUTION;ORAL	077218-001	Jan 12, 2005		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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: November 7, 2026

Potassium iodide is a mature, low-cost drug with limited patent protection and demand driven primarily by government stockpiling, nuclear emergency preparedness, and episodic consumer purchasing. The commercial market has low technological barriers but high procurement and regulatory barriers. Revenue is concentrated in a small group of manufacturers and distributors, while total market growth is irregular rather than structurally high.

What is the commercial use of potassium iodide?

Potassium iodide, or KI, is used for thyroid blocking after exposure to radioactive iodine. It saturates the thyroid with stable iodine and reduces uptake of radioactive iodine isotopes such as iodine-131. It does not protect against other forms of radiation and does not treat general radiation injury.[1]

The principal commercial dosage forms are:

Product type	Typical strength	Primary market	Commercial characteristics
Tablets	65 mg	Children and adults requiring adjusted dosing	Most common stockpiling format
Tablets	130 mg	Adults	Preferred for standard adult thyroid-blocking dose
Oral solution	Variable	Infants, young children, patients unable to swallow tablets	Smaller and more specialized market
Saturated solution of potassium iodide, or SSKI	Approximately 1 g/mL	Certain prescription uses, including thyroid-related indications	Separate clinical market from nuclear preparedness

FDA-approved potassium iodide labeling identifies thyroid blocking after a nuclear radiation emergency as the principal indication for the 65 mg and 130 mg tablet products.[2]

How large is the potassium iodide market?

No single public source provides a reliable, audited global potassium iodide market total. Product-level revenue is generally not disclosed, and private-sector sales are mixed with government procurement, hospital purchasing, wholesale distribution, and consumer emergency sales.

The market has four economically distinct segments:

National and regional government stockpiles.
Institutional purchases by hospitals, nuclear facilities, schools, and local authorities.
Pharmacy and e-commerce sales.
Prescription potassium iodide products, including SSKI.

Government procurement is the most important segment for strategic volume. Retail demand is more visible but less predictable. Government tenders can create large order spikes followed by periods of low replenishment. Retail purchases often rise after nuclear accidents, geopolitical events, or official public-health warnings.

Why market-size estimates vary

Commercial market reports often combine different products and uses under the term "potassium iodide market." Some include industrial iodine compounds, animal-health products, nutritional iodine, and laboratory chemicals. Those categories should not be treated as equivalent to the human pharmaceutical market.

For pharmaceutical analysis, the relevant market is narrower:

FDA-authorized or otherwise regulated human products.
Tablets and oral solutions intended for therapeutic use.
Government and institutional stockpiles.
Prescription formulations used for thyroid conditions.

This narrower market is mature and price-sensitive. Volume can increase sharply during emergency-preparedness cycles, but recurring annual growth is limited.

Which companies sell potassium iodide products?

The leading commercial suppliers have included Anbex, Inc., Recipharm AB and associated product distributors, and generic pharmaceutical manufacturers. Product availability changes by jurisdiction and procurement contract.

Principal branded products

Product	Company or supplier association	Strengths	Market position
IOSAT	Anbex-associated product line	130 mg and related tablet presentations	Established U.S. emergency-preparedness brand
ThyroSafe	Anbex, Inc.	65 mg tablets	Established lower-strength U.S. product
Generic potassium iodide tablets	Multiple manufacturers and distributors	Commonly 65 mg or 130 mg	Price-driven and tender-oriented
SSKI solution	Multiple prescription manufacturers	Oral liquid	Separate prescription segment

The commercial market is not controlled by a single global pharmaceutical company. Manufacturing and distribution relationships can change through contract manufacturing, product acquisition, wholesaling, and government awards.

What is the FDA regulatory status of potassium iodide?

FDA has approved potassium iodide products for use as a thyroid-blocking agent in a radiation emergency. The FDA also provides guidance on appropriate dosing by age and on the limits of potassium iodide protection.[2]

The usual public-health dosing framework is:

Population	Typical potassium iodide dose
Adults	130 mg
Children over 3 and up to 18 years	65 mg, with age and size considerations
Infants and young children	Lower dose based on age
Newborns	Lowest dose, with medical supervision

The Centers for Disease Control and Prevention states that potassium iodide should be taken only when directed by public-health or emergency-management officials. The drug is most effective when taken shortly before or soon after exposure to radioactive iodine.[1]

Is potassium iodide an over-the-counter drug?

Potassium iodide products occupy a mixed regulatory position. Some products are marketed through FDA-approved applications, while other formulations and uses fall under prescription or different regulatory pathways. Product status depends on the specific formulation, indication, labeling, and manufacturer.

The public should distinguish FDA-approved emergency products from dietary iodine supplements. Dietary supplements are not substitutes for approved potassium iodide emergency products.

What is the Orange Book status of potassium iodide?

Potassium iodide has a weak Orange Book and patent-exclusivity profile compared with newer prescription drugs.

The active ingredient is an old, simple inorganic salt. Its basic composition is not protected by a modern composition-of-matter patent. The relevant commercial protections, where present, are more likely to involve:

Product-specific formulations.
Manufacturing processes.
Packaging or stability systems.
Dosage presentation.
Labeling or method-of-use claims.
Trade names and distribution arrangements.

The FDA Orange Book should be reviewed at the specific product and application level because listings may differ between approved formulations and manufacturers.[3] A product’s inclusion in the Orange Book does not mean the active ingredient has a commercially meaningful patent barrier.

What patents protect potassium iodide products?

No fundamental patent estate is expected to block generic potassium iodide tablets on the basis of the active ingredient. The molecule is a long-established inorganic compound with extensive prior use in medicine and public-health preparedness.

Potentially relevant intellectual-property categories include:

Protection category	Likely commercial importance
Potassium iodide composition claims	Very low for the mature active ingredient
Novel tablet excipient systems	Low to moderate if a specific formulation has stability or taste advantages
Child-friendly dosage forms	Low unless linked to a differentiated delivery system
Packaging and moisture protection	Moderate for long-term stockpiles
Manufacturing process patents	Usually limited unless the process materially improves purity, yield, or shelf life
Method-of-use claims	Limited because emergency thyroid blocking is an established use
Trademarks and trade dress	More important than patent rights in retail competition

The competitive advantage in this market generally comes from regulatory readiness, manufacturing reliability, government-contract eligibility, inventory, and distribution rather than patent exclusivity.

When does potassium iodide lose exclusivity?

Potassium iodide has no meaningful remaining new chemical entity exclusivity for its established emergency-use products. Any historical regulatory exclusivity attached to specific applications would have expired long before the current commercial period.

The relevant exclusivity timeline is:

Period	Market event
Historical period	Potassium iodide used medically and for thyroid-related conditions
20th century	Established use in radiation preparedness and thyroid treatment
2000s	U.S. FDA approvals and commercialization of dedicated emergency tablets
2010s	Expanded government and institutional stockpiling after nuclear incidents
Current market	Generic and branded competition with limited patent leverage

Patent expiry is therefore not the primary driver of market entry. Regulatory approval, product quality, supply continuity, and procurement qualification matter more.

Are there Paragraph IV challenges to potassium iodide?

Paragraph IV litigation risk is low. Potassium iodide tablets are not a typical target for high-value Abbreviated New Drug Application litigation because:

The active ingredient is old and inexpensive.
The market price is low.
Branded products have limited revenue concentration.
Any formulation patents are unlikely to support large damages claims.
Government procurement often focuses on supply assurance rather than brand substitution.

A generic applicant could use a Paragraph IV certification if an Orange Book-listed patent were relevant to the reference product. The economic incentive to litigate would depend on the value of the specific contract or market niche, not the underlying active ingredient.

What patent litigation affects potassium iodide?

There is no widely reported, high-value patent litigation campaign comparable with litigation involving oncology, immunology, diabetes, or specialty-drug products.

The more material legal risks are commercial and regulatory:

Contract disputes involving government tenders.
Supply and quality disputes.
Product-liability claims.
Trademark disputes.
Manufacturing interruptions.
Recall exposure.
Allegations concerning labeling or emergency-use communications.

For investors and procurement agencies, the absence of major patent litigation reduces legal uncertainty but does not eliminate supply-chain risk.

How strong is the potassium iodide patent estate?

The patent estate is weak for the active ingredient and moderate at most for differentiated products.

Patent-strength assessment

Factor	Assessment	Reason
Composition-of-matter protection	Weak	Mature, well-known inorganic salt
Method-of-use protection	Weak	Thyroid blocking and thyroid-related uses are established
Formulation protection	Low to moderate	Possible for liquid stability, taste masking, or pediatric delivery
Manufacturing protection	Low to moderate	Process improvements may be proprietary but are unlikely to block the market
Trademark protection	Moderate	Brand recognition can support procurement and retail preference
Regulatory and procurement barriers	Moderate to high	Government qualification and supply reliability are important
Overall patent durability	Low	Commercial position depends on execution rather than exclusivity

What formulations are protected by potassium iodide patents?

The most plausible formulation opportunities involve products that solve practical problems rather than create a new pharmacology.

Potential differentiation areas include:

Stable oral solutions with controlled concentration.
Pediatric liquid formulations.
Unit-dose packaging.
Moisture-resistant tablets for long-term stockpiling.
Products with improved taste or easier administration.
Packaging designed for rapid emergency distribution.
Combination emergency kits containing potassium iodide and other supplies.

These products may receive patent protection if they contain a novel formulation or delivery system. Patent value is constrained by the low price of standard tablets and the ability of competitors to design around narrow claims.

Is there biosimilar risk for potassium iodide?

There is no biosimilar risk. Potassium iodide is a small-molecule inorganic salt, not a biologic. Competition occurs through generic-drug, prescription, OTC, tender, and direct procurement channels.

The relevant substitutes are not biosimilars but:

Other potassium iodide tablet manufacturers.
Compounded oral solutions.
Alternative iodine products that are not clinically interchangeable for radiation emergencies.
Stockpiling from different authorized suppliers.

What drives potassium iodide revenue?

Revenue follows procurement timing more closely than medical utilization.

Main revenue drivers

Government demand is usually the largest source of large-volume orders. National stockpiles are replenished based on expiration dating, inventory targets, nuclear facility planning, and geopolitical assessments.

Institutional demand comes from nuclear power operators, hospitals, schools, emergency agencies, and local governments. These buyers value shelf life, documentation, packaging, and delivery reliability.

Retail demand increases after public attention to nuclear accidents or geopolitical events. The increase can be substantial but usually fades after the event.

Prescription demand for SSKI and related potassium iodide uses is more stable but represents a different market with different prescribers, pharmacies, and reimbursement dynamics.

What is the financial trajectory for potassium iodide?

The financial trajectory is best characterized as low-growth, episodic, and procurement-sensitive.

Financial factor	Expected effect
Base demand	Stable but limited
Government tenders	Can create sharp revenue spikes
Retail emergency demand	Volatile and event-driven
Pricing	Low, with strong generic pressure
Gross-margin potential	Better for branded, packaged, or specialized products than bulk tablets
Working-capital needs	Can rise when manufacturers build inventory for uncertain tenders
Forecast visibility	Low to moderate
Long-term growth	Limited without geographic expansion or product differentiation

Public companies generally do not report potassium iodide revenue as a separate segment. Financial analysis must therefore rely on contract awards, product availability, manufacturing announcements, regulatory filings, and distributor data.

Revenue scenarios

Base case

Stable government replenishment, modest institutional demand, and low but recurring retail sales. Revenue grows near overall procurement and population trends.

Upside case

A major nuclear incident, heightened geopolitical risk, or expanded government preparedness program leads to accelerated orders and temporary price firming. Suppliers with available finished inventory benefit first.

Downside case

Government stockpiles remain adequate, tenders are delayed, or new suppliers enter with lower prices. Retail demand normalizes after an emergency-related surge.

Which companies are challenging the potassium iodide market?

Competition is fragmented. The most credible challengers are generic pharmaceutical manufacturers, contract manufacturers, specialist emergency-preparedness suppliers, and distributors that can meet government specifications.

A new entrant must establish:

FDA-compliant manufacturing.
Reliable active-ingredient sourcing.
Validated assay and impurity controls.
Long-term stability data.
Packaging suitable for stockpiling.
National or regional distribution.
Government-contract eligibility.
Product liability and recall controls.

The low cost of the active ingredient does not eliminate these barriers. A supplier can manufacture tablets inexpensively but still fail to win tenders because of limited shelf life, weak documentation, insufficient inventory, or a lack of procurement history.

What manufacturing and intellectual-property barriers affect potassium iodide?

The principal manufacturing risks are operational rather than technological.

Active-ingredient sourcing

Potassium iodide is widely available, but pharmaceutical-grade material requires appropriate purity, testing, traceability, and supply controls. A disruption affecting iodine production, chemical processing, or international shipping can affect finished-product availability.

Shelf life and packaging

Government stockpiles require products that remain within specification for extended periods. Moisture control, tablet integrity, packaging seals, and stability data can determine whether a product qualifies for long-term storage.

Quality control

Manufacturers must control assay, uniformity, dissolution, impurities, microbial quality for liquids, and packaging integrity. Oral solutions face additional risks involving concentration accuracy, contamination, and preservative performance.

How does potassium iodide compare with other emergency medicines?

Attribute	Potassium iodide	Naloxone	Prussian blue	Amifostine
Primary emergency use	Radioactive iodine exposure	Opioid overdose	Certain internal radioactive contamination	Radiation protection in specific clinical contexts
Product class	Small-molecule salt	Small molecule	Coordination compound	Small molecule
Patent strength	Low	Varies by product	Limited to moderate by formulation	Product-specific
Demand pattern	Stockpile and event-driven	Recurring public-health demand	Specialized and episodic	Narrow clinical demand
Main commercial barrier	Procurement and supply	Distribution and reimbursement	Specialized manufacturing and procurement	Clinical adoption and regulation

Potassium iodide has less recurring clinical demand than naloxone and fewer high-value formulation opportunities than many specialty emergency products.

What are the generic launch scenarios for potassium iodide?

Generic entry is commercially feasible, but a successful launch requires more than a low manufacturing cost.

Scenario one: standard tablet entry

A manufacturer launches 65 mg or 130 mg tablets and competes on price. This is the most likely route but also the most exposed to tender compression.

Scenario two: government-stockpile specialization

A supplier targets national, state, or nuclear-facility contracts with extended shelf life, unit-dose packaging, and inventory commitments. This can produce larger orders but requires procurement capability.

Scenario three: pediatric or liquid differentiation

A manufacturer develops an oral liquid or easier-to-administer pediatric product. The addressable market is smaller, but competition may be less commoditized.

Scenario four: emergency kit integration

Potassium iodide is bundled into broader emergency products. This shifts competition from pharmaceutical price alone to logistics, packaging, and institutional distribution.

What licensing deals affect potassium iodide?

There is no widely reported licensing model comparable with the royalty-bearing arrangements common for patented specialty drugs. Commercial relationships are more likely to involve:

Contract manufacturing.
Product distribution.
Government supply agreements.
Private-label sales.
Regional commercialization rights.
Emergency stockpile procurement.

The absence of major licensing economics reflects the weak patent position and low unit price. Value is generally captured through manufacturing scale, tenders, and distribution rather than royalty streams.

What geographic markets are most important?

The United States is commercially important because of FDA-approved products, federal and state preparedness programs, nuclear power infrastructure, and established emergency-management procurement.

Europe has a more fragmented market, with procurement often organized at the national or regional level. Demand can rise sharply after nuclear incidents or changes in emergency policy.

Japan has a distinct preparedness market shaped by nuclear-facility policy and the experience of the Fukushima Daiichi accident. Government and local-authority distribution can be more important than retail sales.

Emerging markets may have lower recurring demand but can present opportunities where nuclear power programs expand or public-health stockpiles are created.

What is the investment outlook for potassium iodide?

Potassium iodide is unlikely to support a conventional high-growth pharmaceutical investment thesis. The investment case depends on procurement access, operating leverage, supply reliability, and portfolio fit.

Potentially attractive characteristics include:

Low clinical development risk.
Simple active ingredient.
Limited patent litigation exposure.
Relatively straightforward tablet manufacturing.
Potential for government contracts.
Ability to sell through multiple channels.

Constraints include:

Low pricing.
Irregular order patterns.
Limited brand loyalty.
Low barriers to basic generic entry.
Dependence on emergency events and public budgets.
Limited opportunity for premium pricing.

For an established manufacturer, potassium iodide can be a useful preparedness-product line. For a standalone entrant, the market may be too small and volatile unless the company has existing government-contract infrastructure or a differentiated delivery system.

Key Takeaways

Potassium iodide is a mature, low-cost pharmaceutical with demand driven by stockpiling and emergency preparedness.
Government procurement is more important than routine clinical prescribing for 65 mg and 130 mg tablets.
The active ingredient has no meaningful modern composition-of-matter patent barrier.
Formulation, packaging, manufacturing, and trademark rights may provide limited differentiation.
Paragraph IV litigation and biosimilar risk are low.
Revenue is episodic, with spikes after nuclear events or geopolitical warnings.
Public companies generally do not disclose potassium iodide revenue separately.
The strongest commercial barriers are regulatory qualification, shelf life, quality systems, inventory, and government-contract access.
The market is suitable as a portfolio product but offers limited standalone pharmaceutical growth.

FAQs

Can potassium iodide be sold as a dietary supplement for nuclear emergencies?

Dietary iodine supplements are not substitutes for FDA-approved potassium iodide emergency products. Emergency products are labeled for thyroid blocking and contain specific doses intended for public-health use.[1,2]

Does potassium iodide protect against all radiation exposure?

No. It protects the thyroid from radioactive iodine uptake. It does not block external radiation or protect organs from radioactive materials that do not contain radioactive iodine.[1]

Is potassium iodide subject to mandatory government stockpiling?

Stockpiling requirements vary by country, state, nuclear facility, and emergency-management program. Government purchasing is generally based on risk assessment, geography, population coverage, and inventory policy.

Can a generic manufacturer obtain premium pricing for potassium iodide?

Premium pricing is difficult for standard tablets. A manufacturer may obtain better economics through extended shelf life, specialized packaging, pediatric formulations, reliable delivery, or bundled emergency-preparedness contracts.

Does potassium iodide have a viable patent-extension strategy?

The standard active ingredient does not offer a practical patent-extension path. A company would need a genuinely novel formulation, delivery system, or packaging technology, and the commercial value would still depend on market size and procurement acceptance.

References

Centers for Disease Control and Prevention. (2024). Potassium iodide (KI) and radiation emergencies. U.S. Department of Health and Human Services. https://www.cdc.gov/radiation-emergencies/hcp/clinical-guidance/potassium-iodide.html
U.S. Food and Drug Administration. (2017). Potassium iodide as a thyroid blocking agent in radiation emergencies. https://www.fda.gov/radiation-emitting-products/radiation-emergency-preparedness-and-response/potassium-iodide-ki
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/
World Health Organization. (2017). Iodine thyroid blocking: Guidelines for use in planning for and responding to radiological and nuclear emergencies. https://www.who.int/publications/i/item/9789241550185

US Patents:	0
Tradenames:	5
Applicants:	6
NDAs:	6
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	29
Patent Applications:	5,473
Drug Prices:	Drug price trends for potassium iodide
What excipients (inactive ingredients) are in potassium iodide?	potassium iodide excipients list
DailyMed Link:	potassium iodide at DailyMed

Summary for potassium iodide

Recent Clinical Trials for potassium iodide

Anatomical Therapeutic Chemical (ATC) Classes for potassium iodide