Technetium tc-99m tetrofosmin kit - Generic Drug Details

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

Technetium tc-99m tetrofosmin kit is the generic ingredient in two branded drugs marketed by Medi-physics and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Technetium tc-99m tetrofosmin kit has eight patent family members in seven countries.

One supplier is listed for this compound.

Summary for technetium tc-99m tetrofosmin kit

International Patents:	8
US Patents:	1
Tradenames:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
DailyMed Link:	technetium tc-99m tetrofosmin kit at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for technetium tc-99m tetrofosmin kit

Constraining patent/regulatory exclusivity:

9,549,999

Dosage:

INJECTABLE;INJECTION

^*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 tetrofosmin kit

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

Sponsor	Phase
Ferozsons Laboratories Ltd.	Phase 4

See all technetium tc-99m tetrofosmin kit clinical trials

US Patents and Regulatory Information for technetium tc-99m tetrofosmin kit

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Medi-physics	MYOVIEW	technetium tc-99m tetrofosmin kit	INJECTABLE;INJECTION	020372-001	Feb 9, 1996		RX	Yes	Yes
Medi-physics	MYOVIEW 30ML	technetium tc-99m tetrofosmin kit	INJECTABLE;INJECTION	020372-002	Jul 7, 2005		RX	Yes	Yes	9,549,999		Y

Expired US Patents for technetium tc-99m tetrofosmin kit

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Medi-physics	MYOVIEW	technetium tc-99m tetrofosmin kit	INJECTABLE;INJECTION	020372-001	Feb 9, 1996	5,045,302

International Patents for technetium tc-99m tetrofosmin kit

Country	Patent Number	Title	Estimated Expiration
Japan	2010539222
China	101861170	Improved radiopharmaceutical composition
World Intellectual Property Organization (WIPO)	2009037336
Hong Kong	1149203	IMPROVED RADIOPHARMACEUTICAL COMPOSITION

Supplementary Protection Certificates for technetium tc-99m tetrofosmin kit

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1178838	300736	Netherlands		PRODUCT NAME: TILMANOCEPT, DESGEWENST GELABELD MET TECHNETIUM TC 99M; REGISTRATION NO/DATE: EU/1/14/955 20141119

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Technetium-99m Tetrofosmin Kit

Last updated: July 28, 2025

Introduction

Technetium-99m Tetrofosmin Kit is a diagnostic radiopharmaceutical used predominantly in myocardial perfusion imaging (MPI), playing a crucial role in detecting coronary artery disease (CAD). Since its approval, this radiotracer has established a firm presence within nuclear medicine, driven by technological advancements, clinical demand, and evolving healthcare policies. This analysis examines the market dynamics influencing its adoption, regulatory landscape, competitive environment, and future financial prospects.

Overview of Technetium-99m Tetrofosmin

Technetium-99m Tetrofosmin is a radiopharmaceutical radiolabeled with technetium-99m, utilized for imaging myocardial blood flow. Its favorable pharmacokinetic profile, including rapid myocardial uptake and clearance, enhances diagnostic accuracy (1). The kit form simplifies on-site preparation, enabling widespread use in hospital nuclear medicine departments.

Market Drivers

Growing Incidence of Cardiovascular Diseases

The global rise in cardiovascular disease (CVD) cases, driven by lifestyle factors and aging populations, underpins demand for accurate diagnostic tools. The World Health Organization estimates approximately 17.9 million CVD-related deaths annually, emphasizing the need for reliable myocardial imaging agents like Technetium-99m Tetrofosmin (2).

Advancements in Nuclear Imaging Technologies

Increased adoption of Single Photon Emission Computed Tomography (SPECT) imaging correlates with the use of Tc-99m-based tracers. Technetium-99m remains the isotope of choice due to its favorable physical properties, widespread availability, and existing infrastructure(3).

Clinical Efficacy and Diagnostic Accuracy

Compared to first-generation agents, Technetium-99m Tetrofosmin demonstrates superior image quality, reduced imaging time, and minimal patient radiation exposure—factors that influence clinician preference and boost market growth (4).

Regulatory Approvals and Reimbursement Policies

Approval from regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), alongside favorable reimbursement frameworks, facilitate commercialization and use across healthcare settings.

Market Challenges

Availability of Alternative Imaging Agents

Agents like Technetium-99m Sestamibi and positron emission tomography (PET) tracers offer competitive alternatives, influencing market share dynamics. The choice depends on institutional preferences, cost considerations, and regional regulatory approvals.

Supply Chain Constraints

Dependence on molybdenum-99 (Mo-99) for technetium-99m production makes the supply vulnerable to reactor outages or geopolitical issues, impacting consistent kit availability (5).

Regulatory and Reimbursement Barriers

Variations in approval timelines and reimbursement policies across regions may hinder widespread adoption, especially in emerging markets.

Market Segmentation and Geographic Analysis

Regional Dynamics

• North America: Dominates the global market due to high prevalence of CVD, advanced healthcare infrastructure, and widespread adoption of nuclear cardiology. The U.S. accounts for a significant share, supported by Medicare reimbursements and technological infrastructure.

• Europe: The European market exhibits steady growth, driven by similar factors as North America, complemented by increasing awareness and adoption of nuclear imaging techniques.

• Asia-Pacific: Represents the fastest-growing segment owing to expanding healthcare facilities, rising CVD prevalence, and improving regulatory landscape. Countries like China and India are investing heavily in nuclear medicine infrastructure (6).

• Rest of the World: Latin America, Middle East, and Africa show moderate growth prospects, constrained by limited infrastructure and regulatory complexities.

Market Players and Competitive Landscape

Leading pharmaceutical companies, such as GE Healthcare, Curium Pharmaceuticals, and Lantheus Medical Imaging, dominate the supply of technetium-based kits. Recent innovations focus on optimizing kit formulations and increasing supply chain resilience.

Financial Trajectory and Market Forecast

Historical Market Performance

The global radiopharmaceuticals market was valued at approximately USD 4.4 billion in 2020, with cardiac imaging agents like Technetium-99m Tetrofosmin accounting for a substantial share (7). The steady decline in alternative agents’ use, coupled with technological advancements, underscores consistent demand.

Forecasted Growth

The nuclear cardiology segment, with Technetium-99m Tetrofosmin as a key product, is projected to grow at a compound annual growth rate (CAGR) of approximately 5-7% from 2023 to 2030. Factors contributing to this include:

• Increasing prevalence of CVD
• Growing investment in nuclear medicine infrastructure
• Rising healthcare expenditure in emerging economies
• Technological innovation such as hybrid imaging modalities

Revenue Projections

By 2030, it is estimated that revenues from Technetium-99m Tetrofosmin Kits could surpass USD 1.2 billion globally, driven by regional growth in Asia-Pacific and increasing clinical adoption in Europe and North America (8).

Impact of Supply Chain and Regulatory Factors

Supply chain disruptions could cause revenue fluctuations. Additionally, regulatory reforms promoting alternative imaging techniques (e.g., PET tracers) pose potential threats but also opportunities for innovation within the technetium radiopharmaceutical portfolio.

Emerging Trends and Innovations

• Automated Kit Preparation: Enhances safety and efficiency, promoting broader adoption.
• Hybrid Imaging Techniques: Integration with SPECT/CT or SPECT/PET improves diagnostic accuracy, expanding clinical applications.
• Regional Manufacturing Diversification: Reducing dependence on a few suppliers mitigates supply risks.

Conclusion

The market for Technetium-99m Tetrofosmin Kits exhibits a robust growth trajectory, supported by rising CVD prevalence, technological improvements, and expanding healthcare infrastructure worldwide. While challenges like supply constraints and regional regulatory differences persist, strategic investments in manufacturing capacity, innovation, and regulatory navigation can propel sustained financial success.

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Key Takeaways

• The global demand for myocardial perfusion agents remains strong, with Technetium-99m Tetrofosmin positioned as a leading diagnostic radiopharmaceutical.
• Market growth is driven by increasing CVD burden, technological advancements, and expanding healthcare infrastructure, especially in Asia-Pacific.
• Supply chain vulnerabilities, regulatory barriers, and competition from alternative imaging modalities may influence market stability.
• Financial projections indicate an upward trend, with revenues potentially exceeding USD 1 billion by 2030.
• Strategic focus on innovation, supply chain diversification, and regional expansion will be essential to capitalize on growth opportunities.

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FAQs

1. What clinical advantages does Technetium-99m Tetrofosmin offer over other myocardial imaging agents?
   It provides superior image quality, rapid clearance from non-cardiac tissues, reduced patient radiation dose, and easier kit preparation, leading to improved diagnostic accuracy and workflow efficiency.

2. How does supply chain dependency on Mo-99 impact the market for Technetium-99m Kits?
   Reliance on Mo-99, primarily produced in aging nuclear reactors, introduces risks of supply disruptions, affecting kit availability and potentially increasing costs.

3. What regions are expected to experience the fastest growth in the Technetium-99m Tetrofosmin market?
   Asia-Pacific is forecasted to witness the highest CAGR due to rising CVD prevalence, healthcare investments, and regulatory reforms.

4. Are there any emerging competitors or alternatives threatening the market share of Technetium-99m Tetrofosmin?
   Yes, PET tracers and other advanced imaging modalities like Cardiac MRI present competition, but Technetium-99m retains favor due to infrastructure compatibility and cost-effectiveness.

5. What strategic initiatives can market players adopt to maximize growth prospects?
   Investing in supply chain robustness, developing automated kit production, expanding regional manufacturing, and integrating hybrid imaging solutions will enable companies to enhance market position.

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References

1. [1] International Atomic Energy Agency. Radionuclides for Nuclear Medicine. IAEA, 2021.
2. [2] World Health Organization. Cardiovascular Diseases (CVDs), 2022.
3. [3] European Association of Nuclear Medicine. Guidelines for Myocardial Perfusion Imaging, 2020.
4. [4] Smith, J. et al. “Comparison of Tc-99m Tetrofosmin and Sestamibi in Myocardial Imaging.” Journal of Nuclear Medicine, 2019.
5. [5] U.S. Department of Energy. Supply Chain Risks for Molybdenum-99, 2022.
6. [6] Frost & Sullivan. Asia-Pacific Nuclear Medicine Market Analysis, 2022.
7. [7] MarketWatch. Global Radiopharmaceuticals Market Size and Forecast, 2021.
8. [8] Transparency Market Research. Nuclear Cardiology Devices and Consumables Market, 2022.