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

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

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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
Roxane	POTASSIUM IODIDE	potassium iodide	SOLUTION;ORAL	018551-001	Feb 19, 1982		DISCN	Yes	No	⤷ 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
Arco Pharms Llc	THYROSHIELD	potassium iodide	SOLUTION;ORAL	077218-001	Jan 12, 2005		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

Last updated: September 6, 2026

Potassium iodide is a low-priced, mature pharmaceutical used primarily for thyroid blocking after exposure to radioactive iodine. Its market is small in routine retail sales but strategically important in government stockpiles, hospital emergency inventories, nuclear-incident preparedness, and selected consumer channels. Revenue is driven by procurement cycles and emergency demand rather than chronic prescribing.

The product has limited patent protection, no meaningful biologic or biosimilar risk, and low technical barriers to tablet production. Commercial risk centers on government purchasing, manufacturing concentration, regulatory compliance, inventory expiration, and episodic demand spikes.

What is potassium iodide used for?

Potassium iodide is administered to saturate the thyroid with stable iodine and reduce uptake of radioactive iodine isotopes. It is not a general radiation antidote and does not protect against external radiation or most radioactive materials. The FDA recommends use only when public-health authorities direct it and when radioactive iodine exposure is a credible risk (U.S. Food and Drug Administration [FDA], n.d.-a).

Common dosage forms include:

Product type	Typical strength	Primary market
Tablets	65 mg	Pediatric and adult emergency stockpiles
Tablets	130 mg	Adult emergency use
Oral solution	Concentration varies	Pediatric, institutional, and emergency use
Individually packaged doses	65 mg or 130 mg	Government and hospital inventories

The market is distinct from ordinary iodine supplements. Consumer dietary supplements generally contain much smaller iodine quantities and are not substitutes for FDA-approved potassium iodide emergency products.

How large is the potassium iodide market?

The addressable market is best measured through procurement volume and product sales because manufacturers generally do not report potassium iodide as a separate revenue line. Public company filings do not identify potassium iodide revenue as a material standalone segment.

The commercial market has four demand pools:

U.S. federal and state emergency stockpiles.
Nuclear power plant and local-government inventories.
Hospital, pharmacy, and occupational-health purchases.
Direct-to-consumer sales during geopolitical or nuclear-safety events.

Routine consumer demand is limited. Government and institutional purchases create the largest orders, but those orders are irregular and can be separated by several years. A single procurement award can materially affect a small manufacturer’s annual potassium iodide revenue while remaining immaterial to a large pharmaceutical company.

What drives potassium iodide demand?

Demand is tied to:

Nuclear power plant emergency planning.
Federal and state radiological emergency programs.
Replenishment of expired stock.
International nuclear-safety concerns.
Military and civil-defense procurement.
Media coverage of nuclear incidents.
Retail panic buying during geopolitical events.

The commercial pattern is therefore “lumpy.” A manufacturer can experience a temporary sales increase after a nuclear accident, regional conflict, or government tender, followed by a return to low baseline demand.

Who manufactures potassium iodide products?

The U.S. market has historically included Anbex, Inc., associated with IOSAT potassium iodide tablets, and Recipharm or other contract manufacturers supporting institutional and regulated supply. ThyroSafe has also been marketed as a potassium iodide emergency product. Product availability varies by dosage form, distributor, regulatory status, and procurement contract.

The most important commercial distinction is between:

FDA-approved prescription products;
products purchased through government channels;
pharmacy-distributed emergency tablets; and
dietary supplements that are not interchangeable with approved emergency products.

The FDA maintains drug approval, labeling, safety, and manufacturing requirements for approved potassium iodide products. The CDC and FDA recommend that individuals do not self-administer potassium iodide unless instructed by public-health authorities (Centers for Disease Control and Prevention [CDC], n.d.; FDA, n.d.-a).

What is the FDA regulatory status of potassium iodide?

Potassium iodide has a long-established regulatory history in the United States. FDA-approved products have included 65 mg and 130 mg tablets intended for thyroid blocking during radiological emergencies. The FDA-approved indication is narrow and does not cover routine supplementation.

Regulatory considerations include:

Regulatory issue	Commercial effect
Emergency-use labeling	Limits routine consumer demand
Prescription status for approved products	Supports pharmacy and institutional channels
Product-specific NDA requirements	Raises compliance costs for small suppliers
Stability and shelf-life	Creates stock rotation and inventory risk
Dosage accuracy	Makes manufacturing quality critical
Pediatric administration	Increases importance of scored tablets and liquid formulations

The product’s long history means clinical and regulatory uncertainty is low. The main regulatory risk is product availability, manufacturing compliance, labeling accuracy, and the ability to maintain adequate shelf life.

What patents protect potassium iodide products?

Potassium iodide has little remaining composition-of-matter patent protection. The active ingredient is an old inorganic salt, and basic tablet formulations are generally based on mature technologies. Any historical patents covering emergency-use formulations, packaging, dosing, or delivery systems are unlikely to create broad modern exclusivity for the active ingredient.

Are potassium iodide products listed in the Orange Book?

FDA-approved potassium iodide products may appear in FDA product databases and, depending on the product and listing status, may be evaluated against Orange Book requirements. The commercial importance of Orange Book protection is limited because potassium iodide products generally do not depend on an active patent estate to sustain pricing.

The key market questions are product approval, current marketing status, manufacturing capacity, and procurement eligibility rather than patent expiry.

Are there Paragraph IV challenges for potassium iodide?

Paragraph IV litigation risk is low. No significant current Paragraph IV campaign is associated with potassium iodide comparable to the challenges involving high-value small-molecule products. The low price, mature chemistry, modest market size, and limited patent protection reduce the financial incentive to pursue complex patent litigation.

Generic entrants would more likely rely on an abbreviated regulatory pathway, contract manufacturing, or private-label supply than on a litigation-led launch strategy.

When does potassium iodide lose exclusivity?

Potassium iodide lost practical molecule-level exclusivity decades ago. The relevant commercial exclusivity periods are product-specific and may involve historical approval dates, regulatory exclusivity, trademarks, packaging, or private procurement arrangements.

A simplified exclusivity timeline is:

Period	Market condition
Before modern emergency programs	Mature pharmaceutical ingredient with broad medical use
Late 20th century	FDA-approved emergency tablets and government procurement
2000s	Expansion of public preparedness and dedicated emergency brands
2010s	Low-cost generic and contract-manufacturing environment
Current market	Procurement- and supply-driven competition with limited patent leverage

Brand value can persist after patent expiry when a supplier has government contracts, recognized emergency packaging, established distribution, or a dependable manufacturing record.

What is the competitive landscape for potassium iodide?

Competition is based on price, availability, regulatory status, shelf life, packaging, and tender eligibility. Product differentiation is modest.

Competitive factor	Importance
FDA approval and compliant labeling	High
Government procurement eligibility	High
Reliable supply and manufacturing capacity	High
Price per dose	High
Shelf life	High
Brand recognition	Moderate
Clinical differentiation	Low
Patent exclusivity	Low

The market is vulnerable to supply disruption because demand is small and manufacturers may not maintain large inventories. A producer may have limited incentive to expand capacity for a product with low routine turnover unless government contracts provide volume certainty.

What generic entry risks exist?

Generic entry risk is structurally high because the active ingredient is inexpensive and technically simple. New entrants could compete through:

65 mg or 130 mg tablets;
hospital and public-health tenders;
private-label products;
contract manufacturing;
emergency preparedness distributors;
international supply agreements.

The main barriers are not chemical complexity. They are regulatory filing costs, quality systems, inventory financing, demand forecasting, stability data, and access to procurement channels.

A generic launch would probably reduce prices in retail and institutional channels. The effect on total market value could be limited because volume is constrained by emergency demand. Price erosion would be more likely than significant market expansion.

What patent litigation affects potassium iodide?

There is no major ongoing patent litigation that defines the commercial outlook for potassium iodide. Litigation exposure is more likely to involve:

Trademark ownership;
Product labeling;
Contract disputes;
Procurement challenges;
Manufacturing quality;
Distribution rights;
Regulatory enforcement.

The absence of major patent litigation reflects the product’s age, low price, and limited commercial value rather than a high level of patent protection.

How strong is the potassium iodide patent estate?

The patent estate is weak for the active ingredient and basic dosage forms. A supplier may still have defensible commercial assets in:

Proprietary packaging;
Child-resistant or unit-dose presentation;
Shelf-life optimization;
Oral-solution delivery;
Pediatric administration systems;
Manufacturing know-how;
Government-contract eligibility;
Brand recognition.

These assets can support commercial positioning but generally do not create durable exclusion comparable to a patented active pharmaceutical ingredient or complex drug-delivery system.

What manufacturing and intellectual-property barriers exist?

Potassium iodide tablet manufacturing is comparatively straightforward, but emergency products have strict quality requirements. Relevant barriers include:

Accurate low-dose and high-dose tablet production;
Uniformity of dosage units;
Stability under long-term storage;
Moisture protection;
Packaging integrity;
Lot traceability;
Validated analytical methods;
Compliance with current good manufacturing practices;
Ability to scale rapidly after a government order.

For oral solutions, manufacturing controls include concentration accuracy, microbial limits, container compatibility, and dosing-device performance.

The strongest barriers are operational. A supplier that cannot maintain shelf life or deliver during a procurement window may lose a contract even if its product is inexpensive.

What government procurement dynamics affect revenue?

Government procurement is the central financial variable. Buyers may include federal agencies, state health departments, local emergency-management authorities, nuclear facilities, hospitals, and international governments.

Procurement contracts can have several effects:

Concentrate revenue into a small number of purchase orders.
Reduce price competition when only a few qualified suppliers exist.
Create working-capital pressure before delivery.
Require inventory rotation before expiration.
Reward suppliers with proven fulfillment records.
Increase forecasting risk when renewal timing is uncertain.

Federal preparedness programs have historically treated potassium iodide as one component of radiological emergency planning. The Strategic National Stockpile and other public-health procurement mechanisms can influence demand, although product-specific awards and volumes change over time (Administration for Strategic Preparedness and Response [ASPR], n.d.).

What is the financial trajectory for potassium iodide?

The likely financial trajectory is stable-to-cyclical rather than high-growth.

Base case

Routine sales remain low and predictable. Revenue comes from recurring institutional replenishment, pharmacies, emergency distributors, and replacement of expired stock. Gross margins depend on manufacturing scale and contract terms.

Upside case

A nuclear incident, geopolitical escalation, expanded public-health preparedness, or major stockpile purchase creates a sharp volume increase. The increase is likely temporary unless governments adopt larger permanent inventories.

Downside case

Government procurement is delayed, stockpiles are not replenished, or competing suppliers expand capacity. Retail demand then falls toward a small maintenance market. Expiration-related write-offs can reduce profitability.

Financial variable	Expected direction
Unit price	Flat to declining
Volume	Irregular and tender-driven
Gross margin	Sensitive to scale and contract size
Patent contribution	Minimal
Government exposure	High
Consumer repeat demand	Low
Inventory risk	Moderate to high
Long-term growth	Limited without new procurement programs

Potassium iodide is therefore more valuable as a specialized preparedness product than as a conventional growth pharmaceutical. A company’s exposure depends on contract access and supply reliability, not on brand pricing power.

How does potassium iodide compare with competing radiation-countermeasure drugs?

Potassium iodide differs from newer medical countermeasures because it is inexpensive, orally administered, and targeted specifically at radioactive iodine exposure.

Product category	Target	Market profile
Potassium iodide	Radioactive iodine uptake by the thyroid	Mature, low-cost, stockpile-driven
Prussian blue	Internal contamination with cesium or thallium	Specialized emergency product
Filgrastim and related agents	Radiation-induced marrow injury in selected settings	Higher-cost biologic market
Supportive hospital care	Acute radiation injury	Institutional, episode-driven

Potassium iodide has the lowest technical and pricing complexity in this group. It also has the narrowest protective scope.

What geographic markets matter?

The United States is commercially important because of federal, state, nuclear-facility, and hospital preparedness programs. European markets are influenced by national radiological-protection policies and nuclear power infrastructure. Countries with nuclear reactors, large civil-defense programs, or active emergency stockpiles can create tender opportunities.

International expansion is constrained by:

National registration requirements;
Local procurement rules;
Language-specific labeling;
Different emergency-dose guidance;
Import controls;
Government tender qualification;
Local pharmacovigilance obligations.

Geographic demand is therefore concentrated in countries with nuclear infrastructure or formal radiological emergency programs.

What licensing deals affect potassium iodide?

Large pharmaceutical licensing transactions are uncommon because the product has low commercial value and limited patent protection. Commercial arrangements are more likely to involve:

Contract manufacturing;
Distribution agreements;
Government supply contracts;
Private-label sales;
Emergency stockpile management;
Regional marketing rights.

The value of a deal depends on committed volume, purchase timing, pricing, shelf-life requirements, and renewal options. A distribution agreement without minimum volume commitments provides limited revenue visibility.

Key Takeaways

Potassium iodide is a mature, low-cost emergency medicine with demand driven by stockpiles and public procurement.
Revenue is irregular and can rise sharply after radiological events or government replenishment orders.
The active ingredient and basic tablet formulations have little practical patent protection.
Paragraph IV litigation and biosimilar risk are negligible.
Competitive advantage comes from regulatory compliance, manufacturing reliability, shelf life, packaging, and procurement access.
Generic entry is technically feasible and could pressure prices, although total market volume is limited.
Government contracts can materially affect small suppliers but are generally immaterial to diversified pharmaceutical companies.
The long-term financial outlook is stable but low-growth, with episodic upside and meaningful inventory risk.

FAQs About Potassium Iodide Market and Exclusivity

Is potassium iodide a profitable pharmaceutical product?

It can be profitable for specialized suppliers with government contracts, but the product has limited recurring demand and low pricing power. Profitability depends on procurement volume, manufacturing scale, and inventory control.

Does potassium iodide have biosimilar competition?

No. Potassium iodide is a small-molecule inorganic salt, not a biologic. Biosimilar regulation does not apply.

Can consumers buy potassium iodide without a prescription?

Availability varies by product, jurisdiction, and distribution channel. Approved emergency products may be sold through pharmacies or emergency suppliers, while dietary supplements are marketed separately. Consumers should follow public-health instructions regarding use (CDC, n.d.).

What is the largest commercial risk for potassium iodide manufacturers?

The largest risk is demand volatility combined with inventory expiration. Manufacturers may need to hold stock for emergency procurement without assurance of frequent replenishment.

Does a nuclear incident create lasting potassium iodide demand?

Usually, an incident creates a temporary surge in purchases. Sustained demand depends on whether governments expand permanent stockpiles, replace expired inventory, or change radiological emergency policy.

References

Administration for Strategic Preparedness and Response. (n.d.). Strategic National Stockpile. U.S. Department of Health and Human Services. https://aspr.hhs.gov/stockpile

Centers for Disease Control and Prevention. (n.d.). Potassium iodide (KI). 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. (n.d.-a). 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. (n.d.-b). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/񎟀

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:	5,465
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

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