TECHNETIUM TC-99M SESTAMIBI KIT - Generic Drug Details

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

Technetium tc-99m sestamibi kit is the generic ingredient in three branded drugs marketed by Lantheus Medcl, Cardinal Health 414, Curium, Jubilant Draximage, and Sun Pharm Inds Inc, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Five suppliers are listed for this compound.

Summary for TECHNETIUM TC-99M SESTAMIBI KIT

US Patents:	0
Tradenames:	3
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	5
Clinical Trials:	7
DailyMed Link:	TECHNETIUM TC-99M SESTAMIBI KIT at DailyMed

Recent Clinical Trials for TECHNETIUM TC-99M SESTAMIBI KIT

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

Sponsor	Phase
GE Healthcare	Early Phase 1
M.D. Anderson Cancer Center	Early Phase 1
National Cancer Institute (NCI)	Early Phase 1

See all TECHNETIUM TC-99M SESTAMIBI KIT clinical trials

Pharmacology for TECHNETIUM TC-99M SESTAMIBI KIT

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Inc	TECHNETIUM TC 99M SESTAMIBI	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	079157-001	Jul 10, 2009	AP	RX	No	No
Lantheus Medcl	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-003	May 23, 1997		DISCN	No	No
Cardinal Health 414	TECHNETIUM TC 99M SESTAMIBI	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	078809-001	Apr 28, 2009	AP	RX	No	No

Expired US Patents for TECHNETIUM TC-99M SESTAMIBI KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lantheus Medcl	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-003	May 23, 1997
Lantheus Medcl	CARDIOLITE	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-001	Dec 21, 1990
Lantheus Medcl	MIRALUMA	technetium tc-99m sestamibi kit	INJECTABLE;INJECTION	019785-003	May 23, 1997

TECHNETIUM TC-99M SESTAMIBI KIT Market Analysis and Financial Projection Experimental

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

Introduction

Technetium Tc-99m sestamibi is a crucial radiopharmaceutical in medical imaging, particularly in cardiac diagnostics. Its market dynamics and financial trajectory are influenced by several factors, including demand, technological advancements, and regulatory environments.

Market Size and Growth

The global Technetium-99m market, which includes Tc-99m sestamibi, is projected to grow significantly. As of 2023, the Technetium-99m market was valued at USD 4.95 billion and 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 Applications and Demand Drivers

Cardiovascular Imaging

Tc-99m sestamibi is predominantly used in myocardial perfusion imaging (MPI) to detect coronary artery disease (CAD). This application accounts for the largest market share due to its critical role in assessing blood flow in the heart. The high prevalence of cardiovascular diseases, particularly in regions like North America, drives the demand for Tc-99m sestamibi[3][4].

Other Clinical Applications

Besides cardiovascular imaging, Tc-99m sestamibi is used in various other clinical applications such as bone scans, respiratory imaging, and tumor imaging. These diverse applications contribute to the overall demand and market growth[3].

Geographical Market Segmentation

North America

North America, particularly the United States and Canada, dominates the Technetium-99m market. This is attributed to advanced healthcare infrastructure, a high prevalence of chronic diseases, and significant investments in medical imaging technology. The U.S. alone conducts over 40,000 Tc-99m-based imaging procedures daily[3].

Emerging Markets

Emerging markets, such as China, are also experiencing rapid growth in demand for Tc-99m-based radiopharmaceuticals. The development of healthcare infrastructure and the need for reliable and cost-effective diagnostic tools drive this growth[3].

Cost-Effectiveness and Economic Considerations

Comparison with Thallium-201

The cost-effectiveness of Tc-99m sestamibi compared to Thallium-201 (Tl-201) is a significant factor. Tc-99m sestamibi is more cost-effective when used efficiently, especially in scenarios with more than two cardiac patients per day. However, Tl-201 can be more cost-effective if used within one or two days of receipt due to its longer half-life[1].

Kit Utilization and Preparation Costs

The cost of a Tc-99m sestamibi kit can vary based on utilization. For example, a kit can prepare doses for up to five patients, but hospitals with limited kit utilization may experience higher costs. The pharmacist's time for reconstitution and quality control also adds to the overall cost, estimated to be between $2.08 and $5.83 per kit[1].

Technological Advancements and Innovation

Improved Radiopharmaceuticals

Ongoing research and development are focused on creating new Tc-99m-based radiopharmaceuticals with improved specificity and sensitivity. These advancements enhance diagnostic accuracy and targeted imaging, driving the demand for Tc-99m[3].

Integration with New Imaging Techniques

The integration of Tc-99m sestamibi with newer imaging techniques, such as single photon emission computed tomography (SPECT), is expected to further enhance its diagnostic accuracy and clinical value. This integration solidifies its role in the fight against cardiac diseases[4].

Regulatory and Safety Considerations

Administration and Safety

Tc-99m sestamibi must be administered under the supervision of a health professional experienced in radiopharmaceuticals. The product is well-tolerated with a low incidence of side effects, and its radiation exposure is comparable to other diagnostic radiological procedures[2][4].

Waste Management

Proper disposal of radioactive waste is crucial. Unused Tc-99m sestamibi must be disposed of according to regulatory guidelines, such as those set by the Canadian Nuclear Safety Commission[2].

Market Challenges and Limitations

Supply Chain and Inventory Management

The short half-life of Tc-99m (6.02 hours) requires daily preparation, which can lead to inventory carrying costs. Efficient use and timely administration are critical to minimize waste and optimize cost-effectiveness[1][2].

Regional Variations

Market dynamics can vary significantly based on regional healthcare infrastructure, pricing contracts, and imaging protocols. Results from one hospital or region may not be generalizable to others[1].

Key Takeaways

• The Technetium-99m market, including Tc-99m sestamibi, is expected to grow at a CAGR of 4.05% from 2024 to 2030.
• Cardiovascular imaging is the largest application segment due to the high prevalence of CAD.
• North America dominates the market, but emerging markets like China are growing rapidly.
• Tc-99m sestamibi is more cost-effective in certain scenarios compared to Tl-201.
• Technological advancements and integration with new imaging techniques are driving market growth.
• Regulatory compliance and efficient supply chain management are crucial.

FAQs

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

Technetium Tc-99m sestamibi is primarily used in myocardial perfusion imaging (MPI) to detect coronary artery disease (CAD) and assess blood flow in the heart.

How does the cost-effectiveness of Tc-99m sestamibi compare to Thallium-201?

Tc-99m sestamibi is more cost-effective when used efficiently, especially with more than two cardiac patients per day. However, Thallium-201 can be more cost-effective if used within one or two days of receipt due to its longer half-life.

What are the key factors driving the growth of the Technetium-99m market?

The growth is driven by the rising demand for Tc-99m-based radiopharmaceuticals, particularly for cardiovascular imaging, cancer detection, and other clinical applications. Advancements in radiopharmaceuticals and integration with new imaging techniques also contribute to market growth.

How does the short half-life of Tc-99m impact its use and cost?

The short half-life of Tc-99m requires daily preparation, which can lead to inventory carrying costs. Efficient use and timely administration are critical to minimize waste and optimize cost-effectiveness.

What are the regulatory considerations for the use of Tc-99m sestamibi?

Tc-99m sestamibi must be administered under the supervision of a health professional experienced in radiopharmaceuticals. Proper disposal of radioactive waste according to regulatory guidelines is also essential.

Cited Sources:

1. Cost-Effectiveness of Thallium-201 versus Technetium·99m - Journal of Nuclear Medicine Technology[1]
2. KIT FOR THE PREPARATION OF TECHNETIUM Tc 99m Sestamibi Injection - Curium Canada Inc.[2]
3. Technetium-99m Market: Industry Analysis and Forecast 2030 - Maximize Market Research[3]
4. Technetium-99m Sestamibi Cardiac Diagnostics - Open Medscience[4]