You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

THYROSAFE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Thyrosafe is a drug marketed by Btg Intl and is included in one NDA.

The generic ingredient in THYROSAFE is potassium iodide. There are two hundred and forty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the potassium iodide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Thyrosafe

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

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for THYROSAFE?
  • What are the global sales for THYROSAFE?
  • What is Average Wholesale Price for THYROSAFE?
Drug patent expirations by year for THYROSAFE

US Patents and Regulatory Information for THYROSAFE

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

THYROSAFE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ThyroSafe (Potassium Iodide)

Introduction

ThyroSafe, a brand of potassium iodide (KI), is a critical medication used primarily as a thyroid blocking agent to prevent the uptake of radioactive iodine in the event of a nuclear emergency. Here, we delve into the market dynamics and financial trajectory of ThyroSafe, exploring its demand, pricing, and the factors influencing its market performance.

Medical Significance of Potassium Iodide

Potassium iodide is not just a radioprotective agent but also has various medical applications. It is used to treat lung congestion, sporotrichosis, and as an antiseptic for sore throats. However, its most significant role is in protecting the thyroid gland from radioactive iodine, a highly carcinogenic substance released during nuclear accidents[4].

Market Demand

The demand for ThyroSafe and other potassium iodide products is highly influenced by geopolitical and environmental factors.

Geopolitical Influences

The demand for potassium iodide pills surged significantly during the Russia-Ukraine war in 2022. European consumers, particularly in countries like Finland, Norway, and Luxembourg, rushed to acquire these pills due to fears of nuclear radiation exposure. This increased demand led to a shortage of stock in pharmacies and a subsequent rise in prices[2].

Emergency Preparedness

In the United States, the FDA has issued guidance on the use of potassium iodide as part of emergency response plans. This guidance includes recommendations for dosage and the projected radiation exposure at which the drug should be used. State and local governments are responsible for implementing these recommendations, which can fluctuate demand based on regional emergency preparedness strategies[1].

Pricing Trends

The pricing of ThyroSafe and other potassium iodide products has been volatile in recent years.

Recent Price Surges

In the first half of 2022, prices for potassium iodide pills, including ThyroSafe, surged due to increased demand in Europe following the Russia-Ukraine conflict. This surge was so significant that the cost of ThyroSafe pills in the US doubled as manufacturer inventories decreased[2].

Long-Term Price Fluctuations

Historically, the price trend for potassium iodide has been influenced by demand and supply dynamics. In periods where demand is low, such as during the first six months of the year in North America and Europe, prices tend to decline. This is often due to saturated markets and high inventory levels. However, any increase in demand, such as during geopolitical tensions or nuclear emergencies, can quickly reverse this trend and drive prices up[2].

Market Structure and Competition

The market for potassium iodide is relatively niche but critical for public health.

Approved Products

Only FDA-approved potassium iodide products can be legally marketed in the United States. As of 2022, ThyroSafe tablets from BTG INTERNATIONAL, Inc., along with other brands like iOSAT from Anbex, Inc., and Potassium Iodide Oral Solution from Mission Pharmacal Company, are available without a prescription[1].

Manufacturer Dynamics

The availability and pricing of ThyroSafe are influenced by the production and distribution strategies of its manufacturer. The FDA works with manufacturers to ensure high-quality, safe, and effective products are available. This collaboration is crucial in maintaining a stable supply chain, especially during times of high demand[1].

Financial Implications

The financial trajectory of ThyroSafe is closely tied to its market demand and the broader economic conditions.

Revenue Fluctuations

The revenue generated from ThyroSafe sales can fluctuate significantly based on demand. During periods of low demand, revenues may decline, while periods of high demand, such as during geopolitical crises, can lead to substantial revenue increases[2].

Cost Containment and Regulatory Policies

The pharmaceutical industry, including the market for ThyroSafe, is subject to various regulatory policies and cost containment measures. These policies can affect the pricing and availability of the drug. For instance, the FDA's user fee programs and other regulatory measures can influence the cost of bringing the drug to market and maintaining its availability[3].

Analyst Insights

Analysts predict that the prices of potassium iodide, including ThyroSafe, will remain volatile due to low demand and the current financial crisis. However, any future geopolitical tensions or nuclear emergencies could quickly shift the market dynamics and drive up prices[2].

Consumer and Public Health Impact

The availability and affordability of ThyroSafe are crucial for public health, particularly in the context of nuclear emergencies.

Public Health Preparedness

The FDA's guidance and the availability of ThyroSafe ensure that communities are better prepared to respond to radiation emergencies. The drug's effectiveness in preventing thyroid gland uptake of radioactive iodine makes it a vital component of public health emergency response plans[1].

Consumer Access

During times of high demand, ensuring that consumers have access to ThyroSafe without significant price barriers is essential. This involves coordination between manufacturers, regulatory bodies, and local health authorities to maintain an adequate supply[2].

Key Takeaways

  • Demand and Pricing: The demand for ThyroSafe is highly influenced by geopolitical events and emergency preparedness, leading to volatile pricing.
  • Market Structure: Only FDA-approved products are available, and the market is relatively niche but critical for public health.
  • Financial Trajectory: Revenue fluctuations are significant, influenced by demand and broader economic conditions.
  • Regulatory Policies: FDA guidelines and regulatory policies impact the availability and pricing of ThyroSafe.
  • Public Health Impact: The drug is crucial for public health preparedness in the event of nuclear emergencies.

FAQs

  1. What is the primary use of ThyroSafe?

    • ThyroSafe is primarily used as a thyroid blocking agent to prevent the uptake of radioactive iodine in the event of a nuclear emergency.
  2. How does geopolitical tension affect the demand for ThyroSafe?

    • Geopolitical tensions, such as the Russia-Ukraine war, can significantly increase demand for ThyroSafe, leading to price surges and stock shortages.
  3. Which other products are FDA-approved for potassium iodide?

    • Besides ThyroSafe, other FDA-approved products include iOSAT tablets from Anbex, Inc., and Potassium Iodide Oral Solution from Mission Pharmacal Company[1].
  4. How does the FDA regulate the use of ThyroSafe?

    • The FDA issues guidance on the safe and effective use of potassium iodide, including dosage recommendations and projected radiation exposure levels[1].
  5. What are the other medical applications of potassium iodide?

    • Potassium iodide is used to treat lung congestion, sporotrichosis, and as an antiseptic for sore throats, among other medical applications[4].

Sources

  1. FDA Frequently Asked Questions on Potassium Iodide (KI)
  2. Procurement Resource: Potassium Iodide Price Trend and Forecast
  3. PubMed: Market structure and drug innovation
  4. US Pharmacist: Potassium Iodide: An Antidote for Radiation Exposure

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.