TECHNETIUM TC-99M EXAMETAZIME KIT - Generic Drug Details

What are the generic sources for technetium tc-99m exametazime kit and what is the scope of freedom to operate?

Technetium tc-99m exametazime kit is the generic ingredient in two branded drugs marketed by Ge Healthcare and Jubilant, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for TECHNETIUM TC-99M EXAMETAZIME KIT

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	3
DailyMed Link:	TECHNETIUM TC-99M EXAMETAZIME KIT at DailyMed

Pharmacology for TECHNETIUM TC-99M EXAMETAZIME KIT

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Jubilant	DRAX EXAMETAZIME	technetium tc-99m exametazime kit	POWDER;INTRAVENOUS	208870-001	Aug 17, 2017		RX	No	No
Ge Healthcare	CERETEC	technetium tc-99m exametazime kit	INJECTABLE;INJECTION	019829-001	Dec 30, 1988		RX	Yes	Yes

Expired US Patents for TECHNETIUM TC-99M EXAMETAZIME KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	CERETEC	technetium tc-99m exametazime kit	INJECTABLE;INJECTION	019829-001	Dec 30, 1988
Ge Healthcare	CERETEC	technetium tc-99m exametazime kit	INJECTABLE;INJECTION	019829-001	Dec 30, 1988

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

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

Introduction

Technetium Tc-99m exametazime, marketed under the trade name Ceretec or Drax Exametazime, is a radiopharmaceutical diagnostic agent used in various medical imaging procedures. This article delves into the market dynamics and financial trajectory of this crucial diagnostic tool.

Market Overview

The market for Technetium Tc-99m exametazime is part of the broader radiopharmaceuticals market, which is experiencing significant growth driven by advancements in healthcare technology and increasing demand for diagnostic imaging.

Market Size and Growth

The global technetium-99m market 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 2034[3].

Drivers of Growth

Several factors are driving the growth of the technetium-99m market, including:

• Increasing Healthcare Expenditure: Governments and private entities are investing more in healthcare infrastructure, which includes advanced diagnostic imaging technologies[3].
• Advancements in Technology: Improvements in Single Photon Emission Computed Tomography (SPECT) detector technology and other nuclear imaging techniques are enhancing diagnostic accuracy and expanding the range of applications[3].
• Health Initiatives: Global health initiatives emphasizing early disease detection and precise imaging techniques are boosting the demand for technetium-99m[3].

Applications and Indications

Technetium Tc-99m exametazime has multiple clinical applications that contribute to its market demand.

Detection of Altered Regional Cerebral Perfusion

It is used as an adjunct in the detection of altered regional cerebral perfusion in stroke and other cerebrovascular diseases. This application is critical for early diagnosis and treatment planning in neurology[1][2].

Leukocyte Labeling

The drug is also used for the labeling of autologous leukocytes to localize intra-abdominal infections and inflammatory bowel disease. This procedure helps in the precise identification of infection sites, which is vital for targeted treatment[1][2].

Pharmacokinetics and Pharmacodynamics

Understanding the pharmacokinetics and pharmacodynamics of Technetium Tc-99m exametazime is essential for its effective use.

Uptake and Distribution

After intravenous injection, the technetium Tc-99m complex is rapidly cleared from the blood. Uptake in the brain reaches a maximum of 3.5-7.0% of the injected dose within one minute, with minimal loss of activity over the next 24 hours except by physical decay of technetium Tc-99m[1][2].

Excretion

About 30% of the injected dose is found in the gastrointestinal tract immediately after injection, with 50% of this amount excreted through the intestinal tract over 48 hours. Additionally, about 40% of the injected dose is excreted through the kidneys and urine over the same period[1][2].

Market Challenges

Despite the growth potential, the market for technetium-99m exametazime faces several challenges.

Supply Chain Disruptions

The COVID-19 pandemic highlighted the vulnerability of the supply chain for radiopharmaceuticals, including technetium-99m. Air freight restrictions and other logistical issues affected the timely availability of these critical diagnostic agents[4].

Regulatory Considerations

Regulatory approvals and compliance are crucial for the market trajectory of technetium-99m exametazime. For instance, Jubilant Radiopharma received approval from Health Canada for Drax Exametazime, which is a significant milestone but also underscores the regulatory hurdles that must be navigated[4].

Financial Trajectory

The financial performance of the technetium-99m exametazime market is closely tied to the broader radiopharmaceuticals market.

Revenue Projections

The radiopharmaceutical theranostics market, which includes technetium-99m exametazime, was valued at USD 1,814.58 million in 2022 and is expected to reach USD 3,441.97 million by 2028, growing at a CAGR of 11.3% from 2022 to 2028[4].

Key Players

Companies like GE Healthcare and Jubilant Radiopharma are key players in the market, contributing to the development, production, and distribution of technetium-99m exametazime kits. Their investments in research and development, as well as their ability to navigate regulatory landscapes, are critical for market growth[1][4].

Future Outlook

The future outlook for the technetium-99m exametazime market is promising, driven by several factors.

Expanding Applications

Technetium-99m is being explored for use in a wider range of clinical studies, particularly in the detection of chronic and noncommunicable diseases. This expansion in applications is expected to further boost market demand[3].

Technological Advancements

Continuous advancements in nuclear imaging technologies, such as SPECT, will enhance the diagnostic accuracy and efficiency of technetium-99m exametazime, making it a more valuable tool in healthcare[3].

Global Health Initiatives

Global health initiatives focusing on early disease detection and precise imaging techniques will continue to drive the demand for technetium-99m exametazime, contributing to its market growth[3].

Key Takeaways

• The technetium-99m market is growing due to increasing healthcare expenditure and technological advancements.
• Technetium Tc-99m exametazime has critical applications in detecting cerebral perfusion in stroke and labeling leukocytes for infection localization.
• Supply chain disruptions and regulatory compliance are key challenges.
• The market is expected to grow significantly, driven by expanding applications and technological advancements.

FAQs

What is Technetium Tc-99m exametazime used for?

Technetium Tc-99m exametazime is used as an adjunct in the detection of altered regional cerebral perfusion in stroke and for the labeling of autologous leukocytes to localize intra-abdominal infections and inflammatory bowel disease[1][2].

How is Technetium Tc-99m exametazime administered?

It is administered intravenously as a diagnostic radiopharmaceutical. The kit for preparation includes technetium Tc-99m pertechnetate, exametazime, and a stannous reductant[1][2].

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

Key drivers include increasing healthcare expenditure, advancements in nuclear imaging technologies, and global health initiatives emphasizing early disease detection and precise imaging techniques[3].

How was the COVID-19 pandemic impacting the technetium-99m market?

The pandemic caused supply chain disruptions, particularly affecting the transport of radioisotopes like technetium-99m, which hampered the timely availability of these diagnostic agents[4].

What is the projected growth rate of the radiopharmaceutical theranostics market?

The radiopharmaceutical theranostics market, which includes technetium-99m exametazime, is expected to grow at a CAGR of 11.3% from 2022 to 2028[4].

Sources

1. DrugBank: Technetium Tc-99m exametazime - DrugBank
2. FDA: Ceretec (technetium tc-99m) injection label
3. Transparency Market Research: Technetium-99m Market Size, Share, Growth & Overview, 2034
4. BioSpace: Radiopharmaceutical Theranostics Market (Product Type, Radioisotope, Source, Application, Indication and End User)
5. NCBI Bookshelf: Technetium-99m - StatPearls