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Last Updated: December 23, 2024

TECHNETIUM TC-99M GLUCEPTATE KIT - Generic Drug Details


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What are the generic sources for technetium tc-99m gluceptate kit and what is the scope of patent protection?

Technetium tc-99m gluceptate kit is the generic ingredient in two branded drugs marketed by Bristol Myers Squibb and Draximage, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for TECHNETIUM TC-99M GLUCEPTATE KIT
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
DailyMed Link:TECHNETIUM TC-99M GLUCEPTATE KIT at DailyMed

US Patents and Regulatory Information for TECHNETIUM TC-99M GLUCEPTATE KIT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Draximage TECHNESCAN GLUCEPTATE technetium tc-99m gluceptate kit INJECTABLE;INJECTION 018272-001 Jan 27, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol Myers Squibb GLUCOSCAN technetium tc-99m gluceptate kit INJECTABLE;INJECTION 017907-001 Approved Prior to Jan 1, 1982 DISCN No 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 GLUCEPTATE KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Technetium Tc-99m Gluceptate Kit

Introduction

Technetium Tc-99m gluceptate is a crucial radiopharmaceutical used in various diagnostic imaging procedures, including kidney and brain imaging, and assessing renal and brain perfusion. The market dynamics and financial trajectory of this drug are influenced by several factors, including technological advancements, regulatory changes, and healthcare demand.

Market Size and Growth

The technetium-99m market, which includes Tc-99m gluceptate, was valued at US$ 6.0 billion in 2023 and is projected to grow at a CAGR of 3.3% from 2024 to 2034, reaching US$ 8.6 billion by the end of the forecast period[3].

Drivers of Market Growth

Increasing Healthcare Demand

The rise in chronic and noncommunicable diseases has led to an increased demand for advanced diagnostic imaging. Governments and healthcare organizations are implementing programs to enhance diagnostic imaging and treatment options, which in turn fuels the demand for technetium-99m based radiopharmaceuticals like Tc-99m gluceptate[3].

Technological Advancements

Advancements in Single Photon Emission Computed Tomography (SPECT) detector technology have expanded the applications of technetium-99m in preclinical research and improved diagnostic accuracy. This technological progress is a significant driver for the market growth of Tc-99m gluceptate[3].

Expansion of Health Infrastructure

The expansion of health infrastructure globally, coupled with an increase in healthcare expenditure, is another key factor bolstering the demand for technetium-99m based radiopharmaceuticals. As healthcare providers invest more in advanced imaging technologies, the market for Tc-99m gluceptate is expected to grow[3].

Financial Implications

Cost of Production and Procurement

The conversion from highly-enriched uranium (HEU) to low-enriched uranium (LEU) for the production of technetium-99m has significant financial implications. This transition requires substantial investment in manufacturing and processing, leading to increased costs that are eventually passed on to healthcare organizations. The cost of producing the non-radioactive portion (ligand) of the radiopharmaceutical also adds to the overall expense[1].

Reimbursement Challenges

Healthcare organizations face reimbursement challenges, particularly with the transition to LEU sources. Initiatives such as the private-payer C-suite reimbursement initiative by United Pharmacy Partners, LLC (UPPI) aim to enhance reimbursement coverage, but the costs associated with the LEU/non-HEU pipeline conversion remain a significant financial burden[1].

Cost Savings Strategies

Studies have shown that strategic use of different radiopharmaceuticals can lead to substantial cost savings. For instance, reserving Tc-99m mercaptoacetyltriglycine (MAG-3) for patients with impaired renal function and using Tc-99m diethylene triamine penta-acetic acid (DTPA) for others can result in annual cost savings ranging from $17,319 to $35,180, depending on the renal function thresholds[2].

Regulatory Environment

Collaboration and Stakeholder Involvement

The transition to LEU sources involves collaboration among various stakeholders, including the National Nuclear Security Administration (NNSA), Nuclear Regulatory Commission (NRC), Centers for Medicare and Medicaid Services (CMS), and the Food and Drug Administration (FDA). This collaborative effort is crucial for ensuring a sustainable and cost-effective supply of technetium-99m[1].

Product Usage and Applications

Diagnostic Imaging

Technetium Tc-99m gluceptate is used for kidney and brain imaging and to assess renal and brain perfusion. It is administered intravenously and rapidly cleared from the blood, with a significant portion excreted in the urine within the first hour post-injection[4].

Cardiac Blood Pool Imaging

In conjunction with Sodium Pertechnetate Tc 99m Injection, Stannous Gluceptate Injection (part of the same kit) is used for cardiac blood pool imaging. This application highlights the versatility of the technetium-99m gluceptate kit in various diagnostic procedures[4].

Pharmacology and Safety

Blood Clearance and Urine Excretion

The pharmacokinetics of Technetium Tc 99m Gluceptate Injection involve rapid blood clearance, with less than 15% of the initial activity remaining in the blood after one hour in patients with normal renal function. The majority of the injected dose is excreted in the urine within 24 hours[4].

Contraindications and Warnings

The use of Technetium Tc 99m Gluceptate Injection is contraindicated in patients with hypersensitivity to the agent. Rare cases of hypersensitivity have been reported, and caution is advised when administering the drug[4].

Market Opportunities

Early Disease Detection and Precise Imaging

As healthcare moves towards early disease detection and precise imaging techniques, the demand for technetium-99m based radiopharmaceuticals is expected to increase. This trend presents lucrative opportunities for stakeholders to capitalize on the expanding use and demand chain of Tc-99m gluceptate[3].

Global Health Initiatives

Global health initiatives emphasizing innovative medical technologies further bolster the market demand for technetium-99m. The COVID-19 pandemic has highlighted the importance of investing in healthcare infrastructure, which includes advanced diagnostic imaging technologies[3].

Challenges and Future Outlook

Supply Chain Stability

Ensuring a stable and sustainable supply of technetium-99m is crucial for the continued growth of the market. The transition to LEU sources and the establishment of a domestic supply chain are key challenges that need to be addressed[1].

Cost Management

Managing the increased costs associated with the production and procurement of technetium-99m will be essential for maintaining the financial viability of healthcare organizations. Strategic cost-saving measures, such as optimizing the use of different radiopharmaceuticals, will be vital[1][2].

Key Takeaways

  • The technetium-99m market, including Tc-99m gluceptate, is projected to grow at a CAGR of 3.3% from 2024 to 2034.
  • Increasing healthcare demand, technological advancements, and expansion of health infrastructure drive market growth.
  • The transition to LEU sources and the establishment of a domestic supply chain pose significant financial and logistical challenges.
  • Strategic use of different radiopharmaceuticals can lead to substantial cost savings.
  • The drug is widely used in diagnostic imaging procedures, including kidney and brain imaging.

FAQs

What is the primary use of Technetium Tc-99m gluceptate?

Technetium Tc-99m gluceptate is primarily used for kidney and brain imaging and to assess renal and brain perfusion.

How does the transition to LEU sources affect the cost of technetium-99m production?

The transition to LEU sources increases the cost of production due to the need for significant investment in manufacturing and processing, which is eventually passed on to healthcare organizations.

What are the potential cost savings from optimizing the use of different radiopharmaceuticals?

Optimizing the use of different radiopharmaceuticals, such as reserving MAG-3 for patients with impaired renal function, can result in annual cost savings ranging from $17,319 to $35,180.

What are the key drivers of the technetium-99m market growth?

The key drivers include increasing healthcare demand, technological advancements in SPECT detector technology, and the expansion of health infrastructure globally.

What are the contraindications for Technetium Tc-99m gluceptate?

The use of Technetium Tc-99m gluceptate is contraindicated in patients with hypersensitivity to the agent.

Sources

  1. Can the SPECT nuclear imaging modality be sustained? - Vizient, Inc.
  2. Technetium (Tc)-99m mercaptoacetyltriglycine (MAG-3) to Tc-99m diethylene triamine penta-acetic acid (DTPA) - Science.gov
  3. Technetium-99m Market Size, Share, Growth & Overview, 2034 - Transparency Market Research
  4. PRODUCT MONOGRAPH DRAXIMAGE® GLUCEPTATE Kit - Jubilant DraxImage Inc.
  5. Evaluation of Available In Vitro 99m Tc-RBC Labeling Techniques - Journal of Nuclear Medicine

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