Technetium tc-99m exametazime kit - Generic Drug Details

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

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
Ge Healthcare	CERETEC	technetium tc-99m exametazime kit	INJECTABLE;INJECTION	019829-001	Dec 30, 1988		RX	Yes	Yes
Jubilant	DRAX EXAMETAZIME	technetium tc-99m exametazime kit	POWDER;INTRAVENOUS	208870-001	Aug 17, 2017		RX	No	No

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	4,615,876
Ge Healthcare	CERETEC	technetium tc-99m exametazime kit	INJECTABLE;INJECTION	019829-001	Dec 30, 1988	4,789,736

Technetium tc-99m exametazime kit Market Analysis and Financial Projection

Last updated: February 14, 2026

How does the market for Technetium Tc-99m Exametazime Kit perform financially and what are the key dynamics?

Market size and growth trajectory

The global market for Tc-99m radiopharmaceuticals, including the Exametazime kit, is estimated to generate approximately $600 million in revenue annually as of 2022. The Compound Annual Growth Rate (CAGR) from 2021 to 2028 is projected at around 4%. The growth is driven by increasing demand for SPECT (Single Photon Emission Computed Tomography) imaging in neurology, cardiology, and oncology.

Revenue breakdown and geographic distribution

North America: accounts for about 45% of the global market share, valued at roughly $270 million in 2022. The US dominates this region, propelled by high healthcare expenditure and expanded patient access to nuclear medicine imaging.

Europe: represents approximately 25%, roughly $150 million, supported by widespread adoption of nuclear medicine and established healthcare infrastructure.

Asia-Pacific: shows the fastest growth at a CAGR of approximately 5%, with markets expanding from $90 million in 2022 to over $130 million by 2028. Growth factors include increasing healthcare investment and rising prevalence of cardiovascular and neurological disorders.

Major players and R&D activity

Leading companies include GE Healthcare, Cardinal Health, and Jubilant DraxImage. These firms have invested significantly in R&D, facilitating the development of more efficient kits that yield better image quality and longer shelf life, thereby expanding usage.

Cost structure and reimbursement policies

The average cost of a Tc-99m Exametazime imaging procedure lies between $800 and $1,200, influenced by regional healthcare policies. Reimbursement policies in North America and parts of Europe favor nuclear imaging, contributing to a stable revenue stream. In contrast, pricing pressures in Asia-Pacific affect profit margins.

Regulatory landscape impact

Regulatory approvals from agencies such as the FDA and EMA remain essential. The expiration of patents related to generics and biosimilars has increased competition, exerting downward pressure on prices.

Supply chain considerations

Dependence on technetium-99m supply from aging nuclear reactors impacts market stability. Recent initiatives aim to diversify sources and develop cyclotron-produced molybdenum-99, but supply disruptions could limit market growth.

Financial forecasts and risk factors

Forecasts suggest the exametazime segment will grow modestly, reaching approximately $700 million globally by 2028. Risks include supply chain vulnerabilities, regulatory hurdles, and shifts toward alternative imaging modalities like PET (Positron Emission Tomography).

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Key takeaways

• The global market for Tc-99m Exametazime kits is valued at roughly $600 million, with a CAGR of 4% projected until 2028.
• North America leads with 45% market share. Asia-Pacific exhibits the fastest growth.
• Major companies invest heavily in R&D to enhance kit efficiency and shelf life.
• Supply chain issues for molybdenum-99 threaten market stability.
• Pricing and reimbursement policies significantly influence revenue streams.

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FAQs

1. What are the primary drivers of growth in the Tc-99m Exametazime market?

Demand for nuclear imaging in neurology, cardiology, and oncology drives growth. Increasing adoption in emerging markets and technological advancements also contribute.

2. How do supply chain issues affect the market?

Dependence on aging nuclear reactors for molybdenum-99 production creates vulnerabilities. Supply disruptions can lead to shortages, impacting revenue and diagnostic availability.

3. What role does regulation play in this market?

Regulatory approvals are critical for product launch and commercialization. Patent expirations stimulate generic competition, affecting pricing and market share.

4. How are new production methods influencing the market?

Cyclotron-based production of molybdenum-99 offers alternative supply but requires significant investment. Its adoption could stabilize supply and potentially lower costs.

5. What are the competitive advantages of market leaders?

Leading companies focus on R&D to improve kit stability, imaging quality, and shelf life, which enhance market penetration and customer loyalty.

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References

1. MarketsandMarkets. "Nuclear Medicine Market by Application, Product, and Region," 2022.

2. GlobalData. "Radiopharmaceuticals Market Forecast," 2022.

3. U.S. Food and Drug Administration. "Radiopharmaceuticals," 2022.

4. International Atomic Energy Agency. "Supply of Molybdenum-99," 2022.

5. Statista. "Medical Imaging Procedures," 2022.