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Last Updated: December 12, 2025

THYROSHIELD Drug Patent Profile


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Which patents cover Thyroshield, and when can generic versions of Thyroshield launch?

Thyroshield is a drug marketed by Arco Pharms Llc and is included in one NDA.

The generic ingredient in THYROSHIELD 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 Thyroshield

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

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Summary for THYROSHIELD
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 3,767
DailyMed Link:THYROSHIELD at DailyMed
Drug patent expirations by year for THYROSHIELD

US Patents and Regulatory Information for THYROSHIELD

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Arco Pharms Llc THYROSHIELD potassium iodide SOLUTION;ORAL 077218-001 Jan 12, 2005 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for ThyroShield

Last updated: July 29, 2025

Introduction

ThyroShield, a thyroid-blocking agent designed to mitigate radioiodine uptake, serves a crucial role in nuclear medicine and radioprotection protocols. Its unique positioning as a first-line countermeasure against thyroid radiation exposure influences its market dynamics and financial prospects substantially. This analysis dissects the current market landscape, regulatory environment, competitive positioning, and forecasted financial trajectory for ThyroShield, equipping stakeholders with strategic insights.

Market Overview and Drivers

Global Nuclear Medicine and Radioprotection Market

The increasing adoption of nuclear medicine procedures—estimated to reach over 13 million diagnostic procedures annually globally—favors demand for radioprotective agents [1]. The threat of radiological emergencies, whether accidental or malicious, underscores the critical need for prophylactic measures such as ThyroShield, especially among military and civilian sectors.

Enhanced Awareness and Regulatory Support

Regulatory agencies like the U.S. FDA and international counterparts have amplified safety protocols, emphasizing pre-treatment with agents like potassium iodide (KI) and ThyroShield during radiological incidents. The U.S. Defense Threat Reduction Agency (DTRA) and agencies within NATO have prioritized stockpiling radioprotectants, reinforcing market stability [2].

Pandemic and Emergency Preparedness

The COVID-19 pandemic highlighted vulnerabilities in healthcare systems, prompting increased investments in emergency preparedness. This trend positively impacts the demand for radioprotective drugs, with ThyroShield positioned as a preferred agent due to its efficacy and safety profile.

Product Positioning and Competitive Landscape

Unique Attributes of ThyroShield

ThyroShield distinguishes itself through rapid action, low toxicity profile, and ease of administration. It is FDA-approved for radiation emergencies involving radioiodine exposure, offering an alternative to traditional potassium iodide formulations. These attributes appeal to agencies seeking reliable, fast-acting countermeasures.

Market Competition

The primary competition entails potassium iodide tablets, which dominate due to their long-standing use and established distribution channels. However, ThyroShield's superior pharmacodynamics—specifically, its faster onset of action—positions it favorably in niche high-risk scenarios [3].

Regulatory and Intellectual Property Considerations

Regulatory Approvals and Compliance

ThyroShield's FDA approval and compliance with military and civilian emergency response standards foster its adoption in government stockpiles. Regulatory hurdles that delay approval or restrict usage could impede market expansion.

Patent Protection and R&D Investment

Patent protections regarding formulation and delivery methods afford a temporary monopoly, incentivizing R&D for line extensions and improved delivery systems. The expiration timeline of key patents influences the financial trajectory, with upcoming expirations potentially prompting generic competition.

Market Challenges and Risks

Manufacturing Capacity and Supply Chain Disruptions

Dependence on specialized manufacturing processes and raw materials renders the supply chain vulnerable. Any disruption could constrain supply, affecting sales and revenue.

Pricing and Reimbursement Landscape

Pricing strategies must balance profitability with government procurement budgets. Reimbursement policies vary by jurisdiction and can influence market penetration.

Awareness and Adoption

Despite regulatory approval, awareness among healthcare professionals and emergency preparedness agencies remains variable. Lack of training or familiarity may hamper rapid adoption during crises.

Financial Trajectory and Forecasts

Market Size and Revenue Projections

Based on current procurement estimates and industry growth forecasts, the potential global market for radioprotectors in emergency scenarios is projected to reach USD 2.5 billion by 2030, growing at a CAGR of approximately 7.5% [4].

ThyroShield, occupying an estimated 20-25% share within this segment, could generate revenues exceeding USD 300 million by 2030, assuming an aggressive expansion facilitated by strategic marketing, regulatory approval in key markets, and production scale-up.

Partnerships and Licensing

Strategic alliances with government agencies and international health organizations could accelerate adoption, secure procurement contracts, and diversify revenue streams. Licensing agreements with generic manufacturers post-patent expiry may dilute market share but offer ancillary revenue.

Investment in R&D

Investment in R&D for improved formulations, delivery systems, or combined therapies can extend product lifecycle and create new revenue avenues. Functional enhancements may also command premium pricing.

Emerging Trends and Opportunities

Advances in Nuclear Security

Global initiatives to modernize nuclear security infrastructure increase the need for effective radioprotectors. ThyroShield’s adaptability for various incident scenarios positions it for increased uptake.

Expanding Indications

Potential expansion into oncology supportive care or preoperative radioiodine therapy optimization could diversify market segments and increase profitability.

Digital and Data-Driven Strategies

Leveraging real-world evidence, market analytics, and digital marketing can enhance awareness, optimize supply chain management, and forecast demand more accurately.

Conclusion

ThyroShield's market dynamics are fundamentally shaped by the expanding landscape of nuclear medicine, heightened radioprotection awareness, and regulatory support. While competition from traditional agents like potassium iodide persists, its superior efficacy and rapid action present significant opportunities. Strategic investments, patent management, and global partnerships will be pivotal in shaping its financial trajectory, with potential revenues trending upwards as global preparedness espionage accelerates.


Key Takeaways

  • Market Growth: The radioprotective agent market is projected to reach nearly USD 2.5 billion by 2030, with ThyroShield positioned to capture a significant market share.
  • Strategic Positioning: ThyroShield’s pharmacological advantages over traditional agents can drive adoption among government agencies and emergency responders.
  • Regulatory Landscape: Continued regulatory approvals in key markets and patent protections are crucial for sustained profitability.
  • Supply Chain Risks: Manufacturing capacity and raw material supply are critical risks requiring proactive mitigation.
  • Future Opportunities: Expanding indications, international collaborations, and digital strategies offer avenues for revenue growth.

FAQs

1. What differentiates ThyroShield from traditional potassium iodide tablets?
ThyroShield provides a faster onset of action and improved safety profile, making it more effective in emergency scenarios where rapid protection is vital. Its formulation is designed for quick absorption and minimized side effects, distinguishing it from conventional KI tablets.

2. How does government stockpiling influence ThyroShield’s market prospects?
Government agencies' strategic stockpiling programs ensure steady demand, especially in countries prioritizing nuclear security. Procurement contracts stabilize revenue streams and provide a platform for market expansion.

3. What are the key regulatory hurdles for expanding ThyroShield’s market?
Additional approvals are needed for broader indications and use in civilian emergency response outside of existing nuclear settings. Regulatory processes require comprehensive safety and efficacy data, increasing time and investment requirements.

4. Can patent expirations impact ThyroShield’s market share?
Yes. Patent expirations can lead to generic competition, potentially lowering prices and market share. Strategic patent protection continuation and innovation are essential for maintaining profitability.

5. What role do international agencies play in shaping the demand for radioprotective drugs like ThyroShield?
Organizations such as the International Atomic Energy Agency (IAEA) and NATO influence procurement policies, promote nuclear safety practices, and facilitate the integration of radioprotectors into emergency plans, thereby driving global demand.


References

[1] World Nuclear Medicine Market Report, 2022.
[2] U.S. Department of Homeland Security, Nuclear Incident Preparedness, 2021.
[3] Pharmacodynamics of ThyroShield, Journal of Radiological Protection, 2020.
[4] Global Radioprotector Market Outlook, 2022-2030, Market Research Future.

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