When do the IOSAT patents expire, and when will generic IOSAT be available?

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
Anbex	IOSAT	potassium iodide	TABLET;ORAL	018664-002	May 12, 2011		OTC	Yes	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: August 1, 2026

IOSAT is a niche potassium iodide product used for thyroid protection after exposure to radioactive iodine. Its investment case depends on government stockpiling, emergency preparedness contracts, manufacturing reliability, and distribution access rather than patent exclusivity. IOSAT has limited conventional pharmaceutical IP value because potassium iodide is an old, generic active ingredient and the product competes with other FDA-recognized potassium iodide formulations.

An investor cannot underwrite IOSAT as a standalone public-equity opportunity because Anbex, Inc., the product’s sponsor and marketer, is privately held. The relevant investment exposure is therefore indirect: private-company financing, acquisition valuation, government procurement, contract manufacturing, or suppliers serving the radiological emergency preparedness market.

What is IOSAT and how does the product work?

IOSAT is a 130 mg potassium iodide tablet intended for use during a radiological emergency involving radioactive iodine. Potassium iodide saturates the thyroid with stable iodine, reducing uptake of radioactive iodine by the thyroid gland. It does not protect against other forms of radiation and does not replace evacuation, sheltering, or other emergency measures.

The product is associated with Anbex, Inc. and is distributed through emergency-preparedness channels, pharmacies, institutional buyers, and government programs. The standard adult dose is generally one 130 mg tablet when directed by public-health authorities. Pediatric dosing uses lower strengths or divided dosing, depending on age and product labeling.

Product	Active ingredient	Strength	Dosage form	Primary use
IOSAT	Potassium iodide	130 mg	Tablet	Thyroid protection after radioactive iodine exposure
ThyroSafe	Potassium iodide	65 mg	Tablet	Pediatric and adult radiological emergency use
ThyroShield	Potassium iodide	65 mg/mL	Oral solution	Radiological emergency use, including pediatric dosing

The FDA identifies potassium iodide as an approved thyroid-blocking agent for certain radiation emergencies. The FDA also states that potassium iodide should be used only when public-health or emergency-management authorities recommend it.[1]

What is the FDA regulatory status of IOSAT?

IOSAT is an FDA-approved potassium iodide product used for nuclear or radiological emergency preparedness. FDA approval provides regulatory legitimacy, but it does not create durable commercial exclusivity for the active ingredient.

Potassium iodide products occupy an unusual regulatory position:

The active ingredient is old, inexpensive, and widely available.
Product demand is episodic rather than chronic.
Regulatory value comes from approved labeling, manufacturing compliance, quality assurance, and procurement eligibility.
Government buyers may prefer FDA-approved products over nonapproved alternatives for emergency stockpiles.
Product availability can depend on manufacturing capacity and supply-chain resilience.

The FDA’s potassium iodide guidance states that products may be used to reduce thyroid exposure to radioactive iodine in a nuclear incident. The guidance also distinguishes potassium iodide from general radiation protection products and warns against unsupervised use.[1]

Does IOSAT have FDA exclusivity?

IOSAT does not have a commercially meaningful period of remaining new-drug exclusivity. Any historic exclusivity associated with the original approval would have expired long ago. Current product economics are driven by regulatory maintenance, market access, and supply contracts rather than NCE, orphan-drug, pediatric, or other active exclusivity rights.

What patents protect IOSAT?

The core IOSAT product has little apparent patent protection with current commercial relevance. Potassium iodide is a long-established chemical compound, and the basic 130 mg tablet concept is unlikely to support a blocking composition-of-matter patent.

Potential IP categories include:

IP category	Relevance to IOSAT	Investment significance
Active-ingredient patent	None of practical relevance	Potassium iodide is an established compound
Basic tablet formulation	Limited	Conventional tablet technology is readily substitutable
Manufacturing process	Possible but narrow	May protect process know-how rather than market access
Packaging and shelf-life controls	Potentially useful	Can support quality and procurement reliability
Trademark rights	IOSAT brand protection	Supports brand recognition but does not block generic entry
Method-of-use claims	Limited	Thyroid blocking after radioactive iodine is an established use
Regulatory exclusivity	Expired or immaterial	Does not materially restrict competition

A patent search should distinguish IOSAT-specific rights from patents covering unrelated potassium iodide formulations, radioprotective compositions, or delivery systems. Patentability would be more plausible for a novel pediatric delivery system, improved stability profile, tamper-resistant package, or specialized emergency kit than for conventional potassium iodide tablets.

When does IOSAT lose exclusivity?

IOSAT has no material future patent-expiration event that would define the investment case. The product is already exposed to generic and therapeutic substitution.

The relevant loss-of-exclusivity analysis is therefore operational:

Exclusivity mechanism	IOSAT position
Composition-of-matter patent	No material remaining protection
Formulation patent	No widely recognized blocking position
Method-of-use patent	Established use; limited blocking value
FDA NCE exclusivity	Expired
Orphan exclusivity	Not applicable
Pediatric exclusivity	No current commercial significance
Trademark	Brand protection remains, but substitution is possible
Government procurement qualification	Commercially important but contract-based

The absence of patent exclusivity does not mean immediate displacement. Emergency products can retain share through approved labeling, stockpile qualification, established procurement relationships, and reliable supply.

What is the Orange Book status of IOSAT?

The Orange Book is most relevant to approved prescription drug products and their listed patent and exclusivity information. IOSAT’s commercial position should not be treated as an Orange Book-protected asset in the manner of a patented branded prescription medicine.

The principal value of IOSAT is its FDA-approved product status and availability for emergency preparedness, not an Orange Book patent listing. Any investment review should verify the current Drugs@FDA record and Orange Book entry directly because product application status, labeling, and sponsor information can change.[2]

Which companies compete with IOSAT?

The main direct competition comes from other potassium iodide products rather than from a different therapeutic class.

ThyroSafe

ThyroSafe is a 65 mg potassium iodide tablet associated with Recipharm or predecessor commercial entities. Its lower strength supports pediatric dosing and may improve dose flexibility compared with a 130 mg adult tablet.

ThyroShield

ThyroShield is an oral potassium iodide solution associated with Fleming Pharmaceuticals. Liquid dosing can support pediatric use and institutional emergency distribution, although liquid products may face different stability, packaging, and handling requirements.

Nonbranded potassium iodide

Unbranded or non-FDA-approved potassium iodide products can compete on price, particularly in consumer preparedness markets. They may be less competitive for federal, state, hospital, or institutional procurement where regulatory status, validated quality, labeling, and documentation carry greater weight.

Competitive factor	IOSAT	ThyroSafe	ThyroShield
Strength	130 mg	65 mg	65 mg/mL
Form	Tablet	Tablet	Oral solution
Adult dosing convenience	High	Requires two 65 mg tablets in some cases	Measurement required
Pediatric flexibility	Moderate	High	High
Manufacturing complexity	Low to moderate	Low to moderate	Moderate to high
Substitution risk	High at molecule level	High at molecule level	High at molecule level
Institutional fit	Strong where approved and available	Strong	Depends on liquid procurement requirements

How strong is the IOSAT patent estate?

The IOSAT patent estate is weak as an investment moat. The product’s defensibility rests on non-patent factors:

FDA-approved labeling and quality systems.
Government and institutional purchasing relationships.
Manufacturing continuity.
Emergency stockpile eligibility.
Brand recognition during a high-consequence event.
Inventory availability and shelf-life management.

This is a supply-and-procurement moat, not a classic pharmaceutical IP moat. The moat can be valuable if competing manufacturers cannot scale quickly, but it can weaken when government tenders open to multiple approved suppliers.

What government contracts and licensing deals affect IOSAT?

The largest commercial opportunity is government stockpiling. Buyers can include federal agencies, state governments, local emergency-management authorities, nuclear utilities, hospitals, and private employers with radiological-response responsibilities.

The U.S. government has historically maintained medical countermeasure programs for radiological and nuclear incidents through agencies such as the Administration for Strategic Preparedness and Response and the Strategic National Stockpile. Federal procurement can create large orders relative to ordinary retail demand, but contracts may be irregular, price-sensitive, and dependent on budget allocations.[3]

No major publicly disclosed licensing transaction is central to the IOSAT investment case. An investor should value any distribution, contract manufacturing, or government supply arrangement based on:

Contract duration.
Minimum purchase commitments.
Renewal provisions.
Price-adjustment clauses.
Expiration and replacement risk.
Inventory ownership.
Product liability allocation.
Manufacturing-site qualification.
Government termination rights.

A contract-heavy model can generate strong revenue in award years and weak results between procurement cycles. Revenue concentration is therefore a central diligence issue.

What patent litigation and Paragraph IV challenges affect IOSAT?

There is no prominent current Paragraph IV litigation framework comparable to the disputes surrounding high-value branded drugs. IOSAT’s active ingredient is generic, and the principal commercial threat is competing approved potassium iodide supply rather than a patent challenge.

Potential legal disputes would more likely involve:

FDA approval or supplement status.
Product quality and manufacturing compliance.
Contract awards.
Trademark use.
False or misleading emergency-preparedness claims.
Product liability.
Distribution or supply agreements.

The lack of Paragraph IV risk reduces litigation exposure but also confirms the absence of a meaningful patent barrier. A new entrant with an approved potassium iodide product could compete without needing to invalidate a valuable IOSAT patent portfolio.

What generic entry risks exist for IOSAT?

Generic-entry risk is high at the molecule and dosage-form levels. The practical question is whether an entrant can obtain approval, manufacture at scale, satisfy quality standards, and secure procurement access.

Generic launch scenarios

Scenario	Timing	Commercial effect
New approved tablet supplier	12 to 36 months after development and regulatory execution	Price pressure and tender competition
Existing approved competitor expands capacity	Immediate to 24 months	Share loss during government procurement
Radiation incident increases demand	Immediate	Temporary volume surge; pricing may remain regulated
Government consolidates suppliers	Contract-cycle dependent	Higher concentration and stronger incumbent position
Supply disruption at IOSAT	Immediate	Competitors can capture institutional accounts
No major incident and low procurement	Ongoing	Retail demand remains limited and volatile

The most credible risk is not a sudden patent cliff. It is gradual substitution by ThyroSafe, ThyroShield, unbranded potassium iodide, or a new approved supplier.

What manufacturing and IP barriers protect IOSAT?

Manufacturing barriers are more important than patents. Potassium iodide is inexpensive, but emergency-use products must meet quality, stability, packaging, labeling, and supply-continuity requirements.

Relevant barriers include:

FDA-compliant manufacturing.
Validated assay and content uniformity.
Stability data supporting shelf life.
Reliable active-ingredient sourcing.
Packaging capable of long-term storage.
Lot traceability and recall readiness.
Ability to build inventory before emergency events.
Capacity to satisfy large government orders.
Compliance with federal procurement and quality clauses.

These requirements create execution risk for new entrants but do not create a permanent moat. A qualified generic manufacturer can eventually reproduce a conventional tablet product.

How does IOSAT compare with other radiological countermeasure investments?

IOSAT has lower scientific and clinical development risk than novel radioprotective drugs because the product is established and approved. It also has much lower pricing power.

Investment attribute	IOSAT	Innovative radioprotective therapy
Clinical development risk	Low	High
Patent value	Low	Potentially high
Demand predictability	Low	Low to moderate
Government dependence	High	Often high
Manufacturing complexity	Moderate	Potentially high
Margin potential	Limited to moderate	Higher if protected
Event-driven upside	High	High
Recurring commercial demand	Low	Depends on indication
Generic substitution	High	Low before patent expiry

IOSAT is better viewed as a regulated emergency-supply business than as a conventional branded pharmaceutical asset.

What revenue exposure and valuation factors matter?

Public financial disclosure for IOSAT is limited because Anbex is privately held. Product-level revenue, gross margin, contract backlog, inventory, and customer concentration should not be inferred from retail availability or government preparedness announcements.

The main valuation drivers are:

Annual government purchase volume.
Share of federal and state stockpile contracts.
Retail and institutional sales mix.
Gross margin after manufacturing and inventory costs.
Expiry-related write-offs.
Contract renewal rates.
Manufacturing concentration.
Working-capital requirements.
Product liability insurance.
Capacity to supply during emergencies.
Competitive pricing in government tenders.

A buyer should apply a lower multiple to revenue that is dependent on occasional stockpile awards than to recurring pharmacy or hospital sales. Inventory can be an asset before a procurement award and a liability after shelf-life deterioration.

What is the investment outlook for IOSAT?

The base case is a stable but niche emergency-preparedness product with limited patent-driven upside. Revenue is likely to remain uneven because routine consumption is low and large orders are tied to public-health policy, nuclear preparedness, and emergency procurement.

The bull case involves expanded federal or international stockpiling, a radiological incident, competitor supply failures, or preferred-supplier status in a major procurement program. The bear case involves tender losses, increased competition from approved alternatives, weak government budgets, product expiration, or manufacturing disruption.

For an acquisition or private investment, IOSAT could be attractive if the purchase price reflects:

Low patent value.
High contract concentration.
Uneven revenue.
Strong regulatory and manufacturing execution.
Limited but defensible emergency-market access.
Working-capital exposure from stockpiled inventory.

The product is less attractive if valued like a protected specialty pharmaceutical. Its economic durability depends on supply reliability and procurement access rather than exclusivity.

Key Takeaways

IOSAT is a 130 mg potassium iodide tablet for thyroid protection after radioactive iodine exposure.
Anbex is privately held, limiting direct public-market investment exposure.
IOSAT has no apparent material remaining patent or regulatory exclusivity.
The Orange Book is not the primary source of commercial defensibility for the product.
ThyroSafe, ThyroShield, and nonbranded potassium iodide products create substantial substitution risk.
Government stockpiling is the principal revenue catalyst.
Manufacturing compliance, shelf life, packaging, and procurement eligibility matter more than patents.
Paragraph IV litigation is not a central risk.
Revenue is likely to be lumpy and contract-dependent.
IOSAT is an emergency-supply and procurement asset, not a conventional high-margin branded-drug franchise.

FAQs

Is IOSAT a patented drug?

No material current patent moat is associated with the basic IOSAT potassium iodide tablet. The active ingredient and its principal medical use are long established.

Can generic manufacturers sell potassium iodide instead of IOSAT?

Yes. Approved competitors and nonbranded products can compete at the active-ingredient level, subject to FDA requirements, labeling, quality standards, and procurement rules.

Does IOSAT protect against all radiation exposure?

No. IOSAT is intended to reduce thyroid uptake of radioactive iodine. It does not protect the body from other radiation types or replace emergency protective measures.

Is IOSAT included in the Strategic National Stockpile?

Potassium iodide has been included in U.S. radiological emergency preparedness planning, but product-specific stockpile holdings and procurement awards can change and should be verified through current government contracting records.

Is IOSAT a strong acquisition target?

It can be attractive as a niche regulated-supply asset when priced for limited patent protection, uneven government demand, and high dependence on manufacturing reliability. It is not an attractive target if valued on the assumptions used for patent-protected specialty medicines.

References

U.S. Food and Drug Administration. (2024). Potassium iodide: Questions and answers. https://www.fda.gov/radiation-emitting-products/radiation-emergency-preparedness-and-response/potassium-iodide-questions-and-answers
U.S. Food and Drug Administration. (2024). Drugs@FDA and Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
Administration for Strategic Preparedness and Response. (2024). Strategic National Stockpile. U.S. Department of Health and Human Services. https://aspr.hhs.gov/SNS/Pages/default.aspx
U.S. Food and Drug Administration. (2024). Nuclear and radiological emergency preparedness. https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/nuclear-and-radiological-emergency-preparedness
U.S. Department of Health and Human Services. (2023). Radiation emergency medical countermeasures. Administration for Strategic Preparedness and Response. https://aspr.hhs.gov/Pages/default.aspx

IOSAT Drug Patent Profile

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Iosat

AI Deep Research

Questions you can ask:

Summary for IOSAT

US Patents and Regulatory Information for IOSAT

IOSAT Investment Analysis: Patent Position, FDA Status, Market Fundamentals, and Generic Entry Risk