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Last Updated: December 23, 2024

TECHNETIUM TC-99M SODIUM PERTECHNETATE - Generic Drug Details


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What are the generic drug sources for technetium tc-99m sodium pertechnetate and what is the scope of patent protection?

Technetium tc-99m sodium pertechnetate is the generic ingredient in six branded drugs marketed by Ge Healthcare, Mallinckrodt, Pharmalucence, Bracco, Lantheus Medcl, Curium, and Northstar Medical, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Summary for TECHNETIUM TC-99M SODIUM PERTECHNETATE
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Mayo ClinicPhase 1
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US Patents and Regulatory Information for TECHNETIUM TC-99M SODIUM PERTECHNETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bracco MINITEC technetium tc-99m sodium pertechnetate generator SOLUTION;INJECTION, ORAL 017339-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ge Healthcare TECHNETIUM TC 99M GENERATOR technetium tc-99m sodium pertechnetate generator SOLUTION;INTRAVENOUS, ORAL 017693-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mallinckrodt SODIUM PERTECHNETATE TC 99M technetium tc-99m sodium pertechnetate SOLUTION;INJECTION, ORAL 017725-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  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

TECHNETIUM TC-99M SODIUM PERTECHNETATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Technetium Tc-99m Sodium Pertechnetate

Introduction

Technetium Tc-99m sodium pertechnetate is a pivotal radiopharmaceutical in nuclear medicine, widely used for diagnostic imaging of various organs and tissues. Its unique properties, including a short half-life of 6 hours and optimal gamma energy for imaging, make it an indispensable tool in medical diagnostics.

Market Size and Growth

The Technetium Tc-99m market is projected to experience significant growth over the coming years. As of 2023, the global Technetium Tc-99m market was valued at USD 4.95 billion, and it is expected to grow at a Compound Annual Growth Rate (CAGR) of 4.05% from 2024 to 2030, reaching nearly USD 6.54 billion by 2030[3].

Key Drivers of Market Growth

Several factors are driving the growth of the Technetium Tc-99m market:

Increasing Demand for Diagnostic Procedures

The rising demand for Tc-99m-based radiopharmaceuticals, particularly for cardiovascular imaging, cancer detection, and other clinical applications, is a major driver. In the United States alone, over 40,000 Tc-99m-based imaging procedures are conducted daily, with around 20 million nuclear medicine procedures performed annually, of which about 60% use Tc-99m[3].

Advancements in Radiopharmaceuticals

Ongoing research and development efforts are focused on creating new Tc-99m-based radiopharmaceuticals with improved specificity and sensitivity. These advancements enable more accurate diagnosis and targeted imaging of various diseases, including cancer, cardiovascular disease, and neurological disorders[3].

Healthcare Infrastructure and Chronic Diseases

North America, particularly the United States and Canada, dominates the global market due to advanced healthcare infrastructure, high prevalence of chronic diseases, and significant investments in medical imaging technology. The high prevalence of cardiovascular diseases and cancer in these regions further fuels the demand for Tc-99m-based imaging[3].

Market Segmentation

The Technetium Tc-99m market is segmented based on several criteria:

By Application

  • Cardiovascular Imaging: This segment holds the largest market share, primarily due to its critical role in myocardial perfusion imaging, which assesses blood flow in the heart.
  • Bone Scans: Used for diagnosing bone disorders and metastatic bone disease.
  • Respiratory Imaging: Helps in diagnosing respiratory conditions.
  • Tumor Imaging: Used for detecting and monitoring tumors.
  • Other Applications: Includes imaging of the thyroid, salivary glands, urinary bladder, and nasolacrimal drainage system[3].

By Isotopic Services

  • Gamma Camera: Used for detecting gamma rays emitted by Tc-99m.
  • Single Photon Emission Computed Tomography (SPECT): A type of nuclear medicine tomographic imaging technique that uses gamma rays[3].

By End User

  • Hospitals: The primary users of Tc-99m-based radiopharmaceuticals.
  • Diagnostic Centers: Also significant users, especially for outpatient procedures.
  • Others: Includes research institutions and pharmaceutical companies[3].

Production and Supply Chain

The production of Technetium Tc-99m has historically been complex due to its reliance on molybdenum-99 (Mo-99), which is typically produced in reactors outside the United States. However, recent developments have aimed to stabilize the supply chain:

Domestic Production

The FDA has cleared the path for the first domestic supply of Tc-99m in the United States through the approval of the RadioGenix System. This system produces sodium pertechnetate Tc-99m injection without the need for highly enriched uranium (HEU), reducing the risk of drug shortages and enhancing national security[2].

Cyclotron Production

Accelerator-based methods, such as those using cyclotrons, are being developed to produce Mo-99 and subsequently Tc-99m. These methods offer a viable alternative to reactor-produced Mo-99 and can meet the needs of a larger patient population at a comparable cost[5].

Financial Impact and Economic Considerations

The financial trajectory of the Technetium Tc-99m market is influenced by several economic factors:

Cost-Effectiveness

The development of new production methods, such as cyclotron-based production, is expected to maintain cost competitiveness with traditional reactor-based methods. This ensures that the cost of Tc-99m remains manageable for healthcare providers and patients[5].

Regulatory and Funding Support

Government funding and regulatory support play a crucial role in the advancement of Tc-99m production technologies. For instance, NorthStar received matching funds from the DOE/NNSA for its accelerator method of producing Mo-99, totaling $11.1 million, which supports the commercialization of these new methods[2].

Market Expansion

The growing demand for Tc-99m-based radiopharmaceuticals, driven by increasing diagnostic procedures and advancements in imaging technologies, is expected to drive market expansion. Companies can capitalize on this growth by developing high-quality, cost-effective Tc-99m products tailored to emerging market needs[3].

Key Takeaways

  • The Technetium Tc-99m market is projected to grow significantly, driven by increasing demand for diagnostic procedures and advancements in radiopharmaceuticals.
  • North America dominates the market due to advanced healthcare infrastructure and high prevalence of chronic diseases.
  • New production methods, such as cyclotron-based production, are stabilizing the supply chain and reducing reliance on foreign reactors.
  • Regulatory and funding support are crucial for the commercialization of new production technologies.
  • The market is segmented by application, isotopic services, and end users, with cardiovascular imaging being the largest segment.

FAQs

  1. What is the primary use of Technetium Tc-99m sodium pertechnetate in medical diagnostics?

    • Technetium Tc-99m sodium pertechnetate is used for imaging various organs and tissues, including the thyroid, salivary glands, gastric mucosa, and choroid plexus, through techniques like SPECT[4].
  2. How is Technetium Tc-99m typically produced?

    • Technetium Tc-99m is produced from its parent nuclide molybdenum-99 (Mo-99), which spontaneously decays to Tc-99m. This is often done using a technetium-99m generator in a hospital setting[4].
  3. What are the challenges in the supply chain of Technetium Tc-99m?

    • Historically, the supply chain has been vulnerable due to the reliance on reactors outside the United States for Mo-99 production. However, new domestic production methods and cyclotron-based production are addressing these challenges[2][5].
  4. What is the expected market size of Technetium Tc-99m by 2030?

    • The global Technetium Tc-99m market is expected to reach nearly USD 6.54 billion by 2030, growing at a CAGR of 4.05% from 2024 to 2030[3].
  5. How does the FDA's approval of the RadioGenix System impact the market?

    • The FDA's approval of the RadioGenix System reduces the risk of drug shortages and strengthens national security by creating a U.S.-based manufacturing capacity for Tc-99m, which is less vulnerable to supply disruptions[2].

Sources

  1. Science.gov - Technetium-99m sodium pertechnetate: Topics by Science.gov
  2. ITN Online - FDA Clears Path for First Domestic Supply of Tc-99m Isotope
  3. Maximize Market Research - Technetium-99m Market: Industry Analysis and Forecast 2030
  4. DrugBank - Technetium Tc-99m pertechnetate
  5. IAEA - Accelerator-based Alternatives to Non-HEU Production of Mo-99 /Tc-99m

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