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Last Updated: April 10, 2025

IODOTOPE Drug Patent Profile


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

Iodotope is a drug marketed by Bracco and is included in one NDA.

The generic ingredient in IODOTOPE is sodium iodide i-131. There are one thousand four hundred and seventy-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sodium iodide i-131 profile page.

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Summary for IODOTOPE
Drug patent expirations by year for IODOTOPE
Recent Clinical Trials for IODOTOPE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Academic and Community Cancer Research UnitedPhase 2
National Cancer Institute (NCI)Phase 1
University of WashingtonPhase 1

See all IODOTOPE clinical trials

US Patents and Regulatory Information for IODOTOPE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Bracco IODOTOPE sodium iodide i-131 CAPSULE;ORAL 010929-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Bracco IODOTOPE sodium iodide i-131 SOLUTION;ORAL 010929-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Bracco IODOTOPE sodium iodide i-131 CAPSULE;ORAL 010929-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 3 of 3 entries

Market Dynamics and Financial Trajectory for Iodine and Related Drugs

Introduction to Iodine and Its Medical Significance

Iodine is a crucial element in the production of various medical and pharmaceutical products, particularly those related to thyroid disorders. The market dynamics for iodine and related drugs are influenced by several key factors, including the prevalence of thyroid disorders, advancements in drug development, and global demand for iodine.

Prevalence of Thyroid Disorders

The global thyroid gland disorder treatment market is driven significantly by the rising incidences of hypothyroidism and hyperthyroidism. These conditions are often linked to iodine deficiency, autoimmune diseases, and an aging population. For instance, the global thyroid gland disorder treatment market was valued at USD 2.22 billion in 2023 and is projected to grow at a CAGR of 3.6% from 2024 to 2030[4].

Market Size and Growth Projections

Anti-Thyroid Drugs Market

The anti-thyroid drugs market, which includes medications used to treat thyroid disorders, is expected to see steady growth. In 2023, this market was valued at $2.4 billion and is projected to grow to $2.46 billion in 2024 at a CAGR of 2.5%. By 2028, it is expected to reach $2.75 billion with a CAGR of 2.8%[1].

Iodine Market

The iodine market itself is also growing, driven by increasing demand for X-ray contrast media and other medical applications. The iodine market size is estimated at 40.64 kilotons in 2024 and is expected to reach 53.06 kilotons by 2029, growing at a CAGR of 5.48% during this period[3].

Key Drivers of Market Growth

Patient Awareness and Education

Increased patient awareness and education about thyroid disorders are significant drivers of the market. As more people become aware of the importance of thyroid health, the demand for related treatments and medications increases[1].

Healthcare Expenditure

Growing healthcare expenditure globally also contributes to the market growth. Regions with improved healthcare facilities and higher public awareness, such as North America, are leading the market in terms of revenue share[4].

Technological Advancements

Advancements in drug development, including precision medicine and targeted drug development, are fueling the growth of the thyroid gland disorder treatment market. For example, the development of new products like Tirosint-SOL, which has been updated by the FDA for hypothyroidism treatment, is a significant factor[4].

Financial Performance of Key Players

Iofina plc

Iofina plc, a specialist in iodine production and chemical manufacturing, has reported strong financial performance. In 2023, the company achieved record sales of $50 million, driven by strong global demand for crystalline iodine. Despite higher inflation and input costs, Iofina's profits remained resilient, and the company moved into a net cash position of $1.2 million. Iofina is also investing heavily in new iodine plants and R&D, doubling its capital investments to $6.2 million in 2023[2].

Revenue and Growth Plans

In the first half of 2024, Iofina reported a record revenue of $26.0 million, a 7% increase over the previous year, despite a 7% drop in average iodine prices. The company is optimistic about its growth trajectory, expecting to produce between 355-380 metric tonnes of crystalline iodine in the second half of the year[5].

Distribution Channels and Market Access

Wholesale Distribution

Wholesale distribution accounts for the largest market revenue share in the thyroid gland disorder treatment market, primarily due to high discounts on bulk purchases and quick services offered by this channel. This distribution method plays a crucial role in making pharmaceutical products accessible to both urban and remote areas[4].

Online Pharmacy Segment

The online pharmacy segment is also growing significantly, with a CAGR of 3.9% during the forecast period. The convenience, accessibility, and ability to compare prices across multiple vendors are driving the growth of online distribution for thyroid medications[4].

Regional Market Dynamics

North America

North America dominates the global thyroid gland disorder treatment market, with the U.S. accounting for a significant share. This is attributed to the prevalence of thyroid diseases, improved healthcare facilities, greater public awareness, and the availability of treatment options[4].

Europe and Asia-Pacific

Europe is the largest market for iodine, while the Asia-Pacific region is expected to witness the highest CAGR between 2024 and 2029. The growing demand for X-ray contrast media and increasing requirements for iodine uptake due to iodine deficiency are driving the market in these regions[3].

Middle East and Africa

The Middle East and Africa (MEA) region is anticipated to witness significant growth due to growing public awareness and demographic shifts such as urbanization and lifestyle changes. However, this region currently holds a low market share value[4].

Challenges and Opportunities

Health-Related Issues

The toxicity of iodine and health-related issues due to excessive consumption pose major restraints to the market growth. However, the rising demand for biocides and the growing demand for recycling iodine are likely to create lucrative market opportunities in the coming years[3].

Alternative Treatments

The market is also seeing trends towards alternative treatments such as thyroid surgery and radioactive iodine alternatives, which could impact the demand for anti-thyroid drugs. Patient-centric care and telemedicine are also becoming more prominent, which may alter the way treatments are delivered and accessed[1].

Key Takeaways

  • The anti-thyroid drugs market and iodine market are expected to grow steadily, driven by the prevalence of thyroid disorders and advancements in drug development.
  • Patient awareness, healthcare expenditure, and technological advancements are key drivers of market growth.
  • Iofina plc and other iodine producers are reporting strong financial performance and investing in growth initiatives.
  • Wholesale distribution and online pharmacy segments are crucial for market access and growth.
  • Regional dynamics vary, with North America leading the market and the Asia-Pacific region showing the highest growth potential.

FAQs

What is the projected growth rate of the anti-thyroid drugs market?

The anti-thyroid drugs market is expected to grow at a CAGR of 2.8% from 2024 to 2028[1].

How is Iofina plc performing financially?

Iofina plc reported record sales of $50 million in 2023 and moved into a net cash position of $1.2 million. The company is also investing heavily in new iodine plants and R&D[2].

What are the major drivers of the iodine market?

The major drivers include increasing demand for X-ray contrast media, growing requirements for iodine uptake due to iodine deficiency, and the rising demand for biocides[3].

Which region dominates the thyroid gland disorder treatment market?

North America dominates the global thyroid gland disorder treatment market, with the U.S. accounting for a significant share[4].

What are the challenges facing the iodine market?

The toxicity of iodine and health-related issues due to excessive consumption are major restraints. However, the market also sees opportunities in the growing demand for biocides and recycling iodine[3].

Sources

  1. The Business Research Company, "Anti-Thyroid Drugs Global Market Report 2024".
  2. Iofina, "2023 Full Year Results".
  3. Mordor Intelligence, "Iodine Market Size & Share Analysis - Industry Research Report".
  4. Grand View Research, "Thyroid Gland Disorder Treatment Market Size Report, 2030".
  5. TipRanks, "Iofina Reports Record Revenue and Growth Plans".

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