COPPER CU-64 DOTATATE - Generic Drug Details

What are the generic sources for copper cu-64 dotatate and what is the scope of freedom to operate?

Copper cu-64 dotatate is the generic ingredient in one branded drug marketed by Radiomedix and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Copper cu-64 dotatate has nineteen patent family members in twelve countries.

One supplier is listed for this compound.

Summary for COPPER CU-64 DOTATATE

International Patents:	19
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	1
DailyMed Link:	COPPER CU-64 DOTATATE at DailyMed

Recent Clinical Trials for COPPER CU-64 DOTATATE

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1

See all COPPER CU-64 DOTATATE clinical trials

Pharmacology for COPPER CU-64 DOTATATE

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for COPPER CU-64 DOTATATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Radiomedix	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227-001	Sep 3, 2020		RX	Yes	Yes	12,102,696		Y
Radiomedix	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227-001	Sep 3, 2020		RX	Yes	Yes
Radiomedix	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227-001	Sep 3, 2020		RX	Yes	Yes	10,159,759

International Patents for COPPER CU-64 DOTATATE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013029616
Poland	3536346
South Korea	20230066382

COPPER CU-64 DOTATATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Copper Cu-64 Dotatate

Introduction

Copper Cu-64 dotatate, marketed as Detectnet, is a diagnostic radiopharmaceutical used in positron emission tomography (PET) scans to localize somatostatin receptor-positive neuroendocrine tumors (NETs). The drug has seen significant market traction and development, particularly in recent years.

Increasing Demand and Production Capacity

The demand for Detectnet has been on the rise, driven by its efficacy in diagnosing NETs. In response to this demand, Curium, the manufacturer, announced a significant increase in production capacity in April 2022. This increase allows for 50% more doses to be available for patient use, starting from the week of May 1, 2022[1][3].

Market Expansion and Patient Access

The increased production capacity is a crucial step in expanding market access and ensuring that more patients can benefit from this diagnostic tool. Curium's commitment to servicing the entire adult neuroendocrine market reflects the growing need for accurate and reliable diagnostic methods for NETs[1][3].

Clinical Efficacy and Comparative Studies

Copper Cu-64 dotatate has demonstrated superior diagnostic performance compared to other radiopharmaceuticals like Gallium-68 DOTATOC. Studies have shown that Copper Cu-64 dotatate has a higher detection rate and better spatial resolution due to its lower positron energy and shorter positron range[4].

Regulatory Approval and Market Validation

The FDA approved Copper Cu-64 dotatate in September 2020 for the localization of NETs, marking a significant milestone in its market validation. This approval was based on clinical trials that demonstrated its high sensitivity and specificity in detecting NETs[4][5].

Financial Implications of Increased Production

The increase in production capacity is likely to have positive financial implications for Curium. Higher production volumes can lead to economies of scale, reducing costs per unit and potentially increasing profit margins. Additionally, meeting the growing demand can result in increased revenue as more patients and healthcare providers adopt Detectnet for diagnostic purposes[1][3].

Revenue Projections and Market Growth

Given the strong clinical data and increasing demand, revenue projections for Copper Cu-64 dotatate are optimistic. The neuroendocrine tumor diagnostic market is expected to grow, driven by the need for accurate and early diagnosis. As Detectnet becomes more widely adopted, Curium can anticipate significant revenue growth in the coming years.

Competitive Landscape

The diagnostic radiopharmaceutical market for NETs is competitive, with other agents like Gallium-68 DOTATOC. However, Copper Cu-64 dotatate's unique properties, such as its longer half-life and superior spatial resolution, position it favorably in the market. The ability to distribute the drug to remote geographical areas due to its longer half-life is another competitive advantage[4].

Patient and Physician Acceptance

The acceptance of Detectnet among patients and physicians is high due to its efficacy and safety profile. Clinical trials have shown that adverse reactions are rare, occurring at a rate of less than 2%, which further enhances its market appeal[3][5].

Logistical and Distribution Advantages

The longer half-life of Copper Cu-64 dotatate (12.7 hours) compared to Gallium-68 (1.1 hours) offers logistical benefits, including easier distribution and a wider scanning window. This makes it more convenient for both healthcare providers and patients, contributing to its market success[4].

Radiation Dosimetry and Safety

While the drug contributes to cumulative radiation exposure, the estimated radiation absorbed doses are manageable, and safe handling procedures are in place to protect patients and healthcare workers. This balance between diagnostic efficacy and safety is crucial for maintaining market confidence[5].

Future Outlook and Research

Continued research and development are expected to further enhance the diagnostic capabilities of Copper Cu-64 dotatate. Studies on its use in various other tumors and conditions that express somatostatin receptors could expand its market potential beyond NETs.

Key Takeaways

• Increased Production Capacity: Curium has increased production to meet growing demand.
• Clinical Efficacy: Superior detection rates and spatial resolution compared to other radiopharmaceuticals.
• Regulatory Approval: FDA approval in 2020 validated its market presence.
• Financial Implications: Expected revenue growth due to increased adoption and production.
• Competitive Advantage: Unique properties such as longer half-life and better imaging quality.
• Patient and Physician Acceptance: High acceptance due to efficacy and safety.
• Logistical Benefits: Easier distribution and wider scanning window.

FAQs

What is Copper Cu-64 dotatate used for?

Copper Cu-64 dotatate, marketed as Detectnet, is used in PET scans to localize somatostatin receptor-positive neuroendocrine tumors (NETs)[2][5].

How has the demand for Detectnet impacted production?

The significant demand for Detectnet has led Curium to increase its production capacity by 50% to meet the market needs[1][3].

What are the advantages of Copper Cu-64 dotatate over other radiopharmaceuticals?

Copper Cu-64 dotatate has a lower positron energy, shorter positron range, and a longer half-life, providing superior spatial resolution and logistical benefits compared to Gallium-68 DOTATOC[4].

What are the potential risks associated with Copper Cu-64 dotatate?

The drug contributes to cumulative radiation exposure, and there are risks of image misinterpretation due to uptake in non-NET tumors or normal physiologic variants. Adverse reactions are rare but can include nausea, vomiting, and flushing[3][5].

How does the longer half-life of Copper Cu-64 dotatate benefit its distribution?

The longer half-life allows for easier distribution to remote areas and a wider scanning window, making it more convenient for healthcare providers and patients[4].

What is the current regulatory status of Copper Cu-64 dotatate?

Copper Cu-64 dotatate was approved by the FDA in September 2020 for the localization of NETs[4][5].

Sources

1. Curium Announces Significant Increase in Detectnet™ (copper Cu 64 dotatate injection) Production Capacity. Biospace.
2. Copper cu 64 dotatate (intravenous route). Mayo Clinic.
3. Curium Announces Significant Increase in Detectnet™ (copper Cu 64 dotatate injection) Production Capacity. Curium Pharma.
4. The emergence of [64Cu]Cu-DOTATATE based somatostatin receptor PET imaging. Journal of Nuclear Medicine.
5. Detectnet (copper Cu 64 dotatate injection), for intravenous use. FDA.