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Last Updated: December 22, 2024

TECHNETIUM TC-99M LABELED CARBON - Generic Drug Details


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

Technetium tc-99m labeled carbon is the generic ingredient in one branded drug marketed by Cyclomedica and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for TECHNETIUM TC-99M LABELED CARBON
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 1
DailyMed Link:TECHNETIUM TC-99M LABELED CARBON at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TECHNETIUM TC-99M LABELED CARBON
Generic Entry Date for TECHNETIUM TC-99M LABELED CARBON*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT
Dosage:
AEROSOL;INHALATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TECHNETIUM TC-99M LABELED CARBON

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

SponsorPhase
National Center for Research Resources (NCRR)N/A
Mayo ClinicN/A
Advanced Breath Diagnostics, LLCN/A

See all TECHNETIUM TC-99M LABELED CARBON clinical trials

US Patents and Regulatory Information for TECHNETIUM TC-99M LABELED CARBON

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cyclomedica TECHNEGAS KIT technetium tc-99m labeled carbon AEROSOL;INHALATION 022335-001 Sep 29, 2023 RX Yes 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

TECHNETIUM TC-99M LABELED CARBON Market Analysis and Financial Projection Experimental

Technetium-99m Market Dynamics and Financial Trajectory

Introduction to Technetium-99m

Technetium-99m (Tc-99m) is a radiopharmaceutical isotope that plays a crucial role in nuclear medicine, particularly in diagnostic imaging. Its unique properties, such as a short half-life of 6 hours and optimal gamma energy for imaging, make it an ideal choice for various medical applications.

Market Size and Growth

The Technetium-99m market is projected to experience significant growth over the next few years. As of 2023, the market size 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[1].

Key Drivers of Market Growth

Rising Demand for Tc-99m-Based Radiopharmaceuticals

The increasing demand for Tc-99m-based radiopharmaceuticals, especially for cardiovascular imaging, cancer detection, and other clinical applications, is a major driver of market growth. Tc-99m is used in more than 80% of all nuclear medicine procedures in the United States, highlighting its widespread adoption[1].

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[1].

SPECT Imaging and Emerging Markets

The sustained imaging power of Single Photon Emission Computed Tomography (SPECT) using Tc-99m radiopharmaceuticals presents significant growth opportunities, especially in emerging markets like China. The demand for reliable and cost-effective diagnostic tools in these regions is increasing, driven by the rapid development of healthcare infrastructure[1].

Market Segmentation

Applications

Tc-99m is utilized in various applications, including:

  • Cardiovascular Imaging: This segment held the largest market share in 2023 due to its critical role in myocardial perfusion imaging, which assesses blood flow in the heart.
  • Bone Scans
  • Respiratory Imaging
  • Tumor Imaging
  • Other Applications[1].

Regional Insights

North America

North America dominated the Tc-99m market in 2023, driven by advanced healthcare infrastructure, a high prevalence of chronic diseases, and significant investments in medical imaging technology. The United States and Canada are major contributors, with the U.S. conducting over 40,000 Tc-99m-based imaging procedures daily[1].

Emerging Markets

Regions like China are experiencing rapid growth in healthcare infrastructure, leading to an increased demand for Tc-99m-based SPECT imaging and other diagnostic tools[1].

Competitive Landscape

The Tc-99m market is highly competitive, with key players such as Siemens Healthineers, GE Healthcare, Medi-Radiopharma, Lantheus Holdings, Inc., and NorthStar Medical Radioisotopes, LLC. These companies are well-established and have a significant market presence, with GE Healthcare and Siemens Healthineers being market leaders due to their advanced technology and extensive distribution channels[1].

Technological Advancements

Development of New Radiopharmaceuticals

The development of new Tc-99m-based radiopharmaceuticals is a critical factor in market growth. For example, the design and development of 99mTc-labeled FAPI tracers have shown excellent binding properties and high affinity, making them powerful tools for diagnostic scintigraphy, especially in cases where PET imaging is not available[2].

Modern Labelling Methods

Modern labelling methods, such as the Tc-99m-metal fragment approach, have facilitated the development of new radiopharmaceuticals with improved clinical potential. These methods have enabled the creation of radiopharmaceuticals for tumour imaging, previously thought to be the prerogative of PET and other radionuclides[3].

Regulatory and Production Challenges

Regulatory Burden

The high cost involved in complying with regulatory standards, including detailed toxicity data and approved clinical studies, is a significant challenge. The regulatory burden needs to be ameliorated to make new Tc-99m-based radiopharmaceuticals more commercially viable[4].

Production and Quality Assurance

Ensuring the local availability of Tc-99m radiopharmaceuticals within a framework of quality assurance is another challenge. The IAEA has published guidelines and technical reports to help in the manufacture of kits for the formulation of various Tc-99m radiopharmaceuticals[4].

Financial Trajectory

Market Forecast

The Tc-99m market is expected to grow from USD 4.95 billion in 2023 to nearly USD 6.54 billion by 2030, driven by the increasing demand for Tc-99m-based radiopharmaceuticals and advancements in imaging technologies[1].

Investment and Funding

Significant investments in medical imaging technology and research and development are driving the growth of the Tc-99m market. For instance, the development of new radiopharmaceuticals and improvements in SPECT technology are attracting substantial funding and investment[1][3].

Key Takeaways

  • The Tc-99m market is projected to grow at a CAGR of 4.05% from 2024 to 2030.
  • The rising demand for Tc-99m-based radiopharmaceuticals, especially in cardiovascular and cancer imaging, is a major growth driver.
  • Advancements in radiopharmaceuticals and SPECT imaging are key factors in market expansion.
  • North America, particularly the United States and Canada, dominates the global market due to advanced healthcare infrastructure and high disease prevalence.
  • The competitive landscape is led by companies like GE Healthcare and Siemens Healthineers.
  • Regulatory and production challenges need to be addressed to fully exploit the market potential.

FAQs

Q: What is the expected market size of the Technetium-99m market by 2030?

A: The Technetium-99m market is expected to reach nearly USD 6.54 billion by 2030[1].

Q: Which region dominates the Technetium-99m market?

A: North America, particularly the United States and Canada, dominates the global Technetium-99m market[1].

Q: What are the primary applications of Technetium-99m in nuclear medicine?

A: The primary applications include cardiovascular imaging, bone scans, respiratory imaging, tumor imaging, and other clinical applications[1].

Q: Who are the key players in the Technetium-99m market?

A: Key players include Siemens Healthineers, GE Healthcare, Medi-Radiopharma, Lantheus Holdings, Inc., and NorthStar Medical Radioisotopes, LLC[1].

Q: What are the challenges in the production and commercialization of new Tc-99m-based radiopharmaceuticals?

A: The high cost of complying with regulatory standards and ensuring quality assurance are significant challenges[4].

Sources

  1. Maximize Market Research: Technetium-99m Market: Industry Analysis and Forecast 2030
  2. Journal of Nuclear Medicine: Design and Development of 99m Tc-Labeled FAPI Tracers for Diagnostic Scintigraphy
  3. MDPI: A Picture of Modern Tc-99m Radiopharmaceuticals: Production, Chemistry, and Applications in Molecular Imaging
  4. IAEA: Technetium-99m Radiopharmaceuticals: Status and Trends
  5. University of New Mexico: Preparation and Dispensing Problems Associated with Technetium-99m Radiopharmaceuticals

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