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 freedom to operate?

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

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			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

International Patents for TECHNETIUM TC-99M TETROFOSMIN KIT

Country	Patent Number	Title	Estimated Expiration
Spain	2562441
China	101861170	Improved radiopharmaceutical composition
Hong Kong	1149203	IMPROVED RADIOPHARMACEUTICAL COMPOSITION
Japan	5764328

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

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

Technetium Tc-99m Tetrofosmin Kit: Market Dynamics and Financial Trajectory

Introduction

Technetium Tc-99m tetrofosmin is a crucial radiopharmaceutical used extensively in nuclear medicine, particularly for myocardial perfusion imaging. This article delves into the market dynamics and financial trajectory of the Technetium Tc-99m tetrofosmin kit, highlighting its applications, market growth, and future prospects.

Applications and Clinical Use

Technetium Tc-99m tetrofosmin is primarily used for myocardial perfusion imaging to delineate regions of reversible myocardial ischemia or infarcted myocardium. It is administered intravenously and forms a lipophilic, cationic complex that is retained in the myocardium based on coronary blood flow and mitochondrial viability[2][4].

Market Size and Growth

The Technetium-99m market, which includes the Tc-99m tetrofosmin kit, is projected to grow significantly. As of 2023, the global Technetium-99m market was valued at USD 4.95 billion and is expected to reach nearly USD 6.54 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.05% from 2024 to 2030[3].

Market Segmentation

The market is segmented based on applications, with cardiovascular imaging being the largest segment. This is due to the critical role of Tc-99m tetrofosmin in assessing blood flow in the heart. Other significant segments include bone scans, respiratory imaging, and tumor imaging[3].

Regional Dominance

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

Drivers of Market Growth

Several factors drive the growth of the Technetium Tc-99m tetrofosmin kit market:

Increasing Demand for Diagnostic Procedures

The rising demand for Tc-99m-based radiopharmaceuticals, especially for cardiovascular imaging and cancer detection, fuels market growth. The frequency of nuclear medicine diagnostic procedures is about 2% per year in developed countries, with the U.S. and Europe conducting millions of such procedures annually[3].

Advancements in Radiopharmaceuticals

Advances in technetium chemistry have led to the development of new radiopharmaceuticals with improved specificity and sensitivity. These advancements enable more accurate diagnosis and targeted imaging of various diseases, including cardiovascular disease, cancer, and neurological disorders[1][3].

Regulatory and Healthcare Infrastructure

The growth is also supported by advanced healthcare infrastructure and significant investments in medical imaging technology. Regulatory standards, although stringent, drive the development of safer and more effective radiopharmaceuticals[1][3].

Financial Trajectory

The financial trajectory of the Technetium Tc-99m tetrofosmin kit market is positive, driven by increasing demand and advancements in technology.

Revenue Projections

The market is expected to grow from USD 4.95 billion in 2023 to nearly USD 6.54 billion by 2030. This growth is fueled by the expanding use of Tc-99m in various clinical applications and the introduction of new radiopharmaceuticals[3].

Cost and Pricing

The cost of Tc-99m tetrofosmin kits is influenced by the cost of technetium-99m production, regulatory compliance, and the complexity of the manufacturing process. Despite these costs, the kits remain a vital tool in nuclear medicine due to their diagnostic accuracy and safety profile[1][2].

Challenges and Opportunities

Regulatory Burden

One of the significant challenges is the high regulatory burden associated with the development and approval of new radiopharmaceuticals. This includes requirements for detailed toxicity data and approved clinical studies, which can be costly and time-consuming[1].

Supply Chain and Production

Ensuring a continuous and reliable supply of Technetium-99m is crucial. The production of Tc-99m is complex and involves the use of molybdenum-99, which has its own set of challenges related to supply and production[1].

Emerging Markets

There is a significant opportunity for growth in emerging markets, particularly in developing countries where access to nuclear medicine is limited. Efforts to make nuclear medicine more accessible and affordable in these regions could expand the market further[1].

Key Players and Competition

The market for Technetium Tc-99m tetrofosmin kits is competitive, with major players such as GE Healthcare and other pharmaceutical companies involved in the production and distribution of these kits. Competition is driven by innovation in radiopharmaceuticals and the ability to meet stringent regulatory standards[2][4].

Conclusion

The Technetium Tc-99m tetrofosmin kit is a cornerstone in nuclear medicine, particularly for cardiovascular imaging. The market for this kit is poised for significant growth, driven by increasing demand for diagnostic procedures, advancements in radiopharmaceuticals, and strong healthcare infrastructure in key regions.

Key Takeaways

• Market Growth: The Technetium-99m market is expected to grow at a CAGR of 4.05% from 2024 to 2030.
• Applications: Primarily used for myocardial perfusion imaging.
• Regional Dominance: North America, especially the U.S. and Canada, dominates the market.
• Drivers: Increasing demand for diagnostic procedures, advancements in radiopharmaceuticals, and strong healthcare infrastructure.
• Challenges: Regulatory burden, supply chain complexities, and ensuring continuous production of Technetium-99m.

FAQs

Q: What is the primary use of Technetium Tc-99m tetrofosmin?

A: It is primarily used for myocardial perfusion imaging to assess blood flow in the heart and delineate regions of reversible myocardial ischemia or infarcted myocardium.

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

A: The market is expected to reach nearly USD 6.54 billion by 2030.

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

A: North America, particularly the United States and Canada, dominates the market.

Q: What are the main drivers of market growth for Technetium Tc-99m tetrofosmin kits?

A: Increasing demand for diagnostic procedures, advancements in radiopharmaceuticals, and strong healthcare infrastructure.

Q: What are some of the challenges faced by the Technetium Tc-99m tetrofosmin kit market?

A: Regulatory burden, supply chain complexities, and ensuring continuous production of Technetium-99m.

Sources

1. IAEA: Technetium-99m Radiopharmaceuticals: Status and Trends[1].
2. GE Healthcare Canada Inc.: MYOVIEW 30 mL [Kit for the Preparation of Technetium Tc99m Tetrofosmin Injection][2].
3. Maximize Market Research: Technetium-99m Market: Industry Analysis and Forecast 2030[3].
4. FDA: MYOVIEW (Kit for the preparation of technetium Tc99m tetrofosmin injection) for intravenous use[4].