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 Curium 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:	3
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
University Hospital, Basel, Switzerland	PHASE1
Vanderbilt-Ingram Cancer Center	PHASE4
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
Curium	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227-001	Sep 3, 2020		RX	Yes	Yes
Curium	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227-001	Sep 3, 2020		RX	Yes	Yes
Curium	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227-001	Sep 3, 2020		RX	Yes	Yes	10,383,961
Curium	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227-001	Sep 3, 2020		RX	Yes	Yes	12,102,696		Y

International Patents for COPPER CU-64 DOTATATE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2022051684
Japan	2023539893	６４Ｃｕ－ＤＯＴＡＴＡＴＥのスケールアップのための放射標識および製剤化
Mexico	2023002614	RADIOMARCADO Y FORMULACION PARA ESCALADO DE 64CU-DOTATATE. (RADIOLABELING AND FORMULATION FOR SCALE UP OF 64CU-DOTATATE.)
European Patent Office	2750717

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Copper Cu-64 Dotatate

Last updated: July 31, 2025

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Introduction

Copper Cu-64 Dotatate represents a significant advancement in the fusion of radiopharmaceutical technology and targeted cancer diagnostics, primarily serving neuroendocrine tumor (NET) imaging. As a PET (positron emission tomography) imaging agent, Cu-64 Dotatate leverages the superior imaging qualities of copper-64 isotopes and somatostatin receptor targeting to enhance early detection and management of NETs. Understanding its market dynamics and financial trajectory is critical for stakeholders, including pharmaceutical companies, investors, healthcare providers, and regulatory agencies.

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Market Overview

Therapeutic and Diagnostic Landscape

Neuroendocrine tumors constitute a growing subset of cancer diagnoses, characterized by their heterogeneous presentation and often elusive detection. Diagnostic imaging solutions like Cu-64 Dotatate address a vital unmet need for precise, non-invasive detection of such tumors.

The global neuroendocrine tumor diagnostics market is projected to grow at a compound annual growth rate (CAGR) of approximately 8-10% through 2030, driven by increased incidence, technological advances, and expanding clinician awareness [1]. Cu-64 Dotatate, as a diagnostic imaging agent, capitalizes on this upward trend, driven further by growing adoption of PET imaging over conventional methods like SPECT.

Regulatory Milestones and Market Entry

In 2019, the U.S. Food and Drug Administration (FDA) approved Netspot (Gallium Ga-68 Dotatate), a comparable agent, reflecting the increasing acceptance of somatostatin receptor PET imaging. Cu-64 Dotatate (not yet FDA-approved as of early 2023) is under development and approval pipelines, with promising clinical trial results indicating superior tumor localization capabilities compared to Ga-68 agents, especially given copper-64's longer half-life and better logistical handling.

Competitive Landscape

• Existing Agents: Ga-68 Dotatate and In-111 Pentetreotide (Octreoscan) dominate the current market, with increasing preference for PET-based imaging due to higher resolution.
• Emerging Technologies: Cu-64 Dotatate offers logistical advantages over Ga-68 agents, owing to copper-64’s 12.7-hour half-life which facilitates centralized manufacturing and wider distribution.
• Pipeline Products: Several biotech firms are developing novel radiopharmaceuticals, either as direct competitors or supplementary agents, potentially affecting Cu-64 Dotatate’s market share.

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Market Dynamics

Innovation and Clinical Validation

Cu-64 Dotatate's potential to improve tumor detection sensitivity and specificity is a key driver. Its longer half-life enables broader distribution, reducing logistical constraints associated with Ga-68 (half-life approximately 68 minutes). Clinical trials have demonstrated Cu-64 Dotatate’s advantages in imaging quality and tumor localization [2], making it a compelling candidate for regulatory approval and commercial adoption.

Regulatory Environment

Regulatory approvals significantly influence market penetration. The success or delay of FDA approval will determine clinical availability and commercialization timelines. The FDA’s accelerated pathways for diagnostic agents addressing unmet medical needs could favor Cu-64 Dotatate, provided efficacy and safety benchmarks are met.

Reimbursement and Pricing

Reimbursement frameworks will heavily influence adoption rates. Currently, radiopharmaceuticals are reimbursed under Medicare and private insurers based on established coding and valuation. As Cu-64 Dotatate advances through clinical trials, securing favorable reimbursement codes will be essential to ensure wide clinical use.

Manufacturing & Supply Chain Logistics

Cu-64’s longer half-life offers logistical advantages, enabling centralized production and distribution over wider geographic regions. This contrasts with Ga-68, which requires on-site generators or short-range transportation. Companies investing in scalable manufacturing infrastructure will position themselves advantageously in this evolving landscape.

Market Adoption and Physician Preference

Physician familiarity, clinical guidelines updates, and demonstrable clinical benefits expedite product adoption. Early partnerships with major cancer centers and imaging providers are crucial to establishing credibility and broad acceptance.

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Financial Trajectory

Development Costs and Investment

Development of Cu-64 Dotatate involves substantial R&D expenses—ranging from preclinical studies to phase III clinical trials—with costs estimated in the hundreds of millions USD [3]. Strategic partnerships, licensing, or acquisition can influence funding needs and timelines.

Revenue Projections

Post-approval, Cu-64 Dotatate’s revenue trajectory depends on market penetration, reimbursement success, and competitive positioning. Assumptions include:

• Initial Market Penetration: 10-15% within the first 3-5 years post-launch, focusing on major cancer centers.
• Pricing Model: Estimated at $3,000-$5,000 per dose, aligning with existing radiopharmaceuticals.
• Volume Growth: CAGR of approximately 20-25% over the first decade, driven by increasing NET diagnoses and expanding awareness.

For context, the global NET diagnostic imaging market could reach USD 1.2 billion by 2030, with Cu-64 Dotatate capturing an increasing share, especially in North America and Europe.

Profitability Outlook

Assuming successful regulatory approval and market entry, profit margins could reach 40-50%, considering manufacturing efficiencies and reimbursement structures. The longer half-life and logistical advantages may also constrain distribution costs, positively impacting the bottom line.

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Market Risks and Challenges

• Regulatory Hurdles: Delays or setbacks in approval processes.
• Competitive Displacement: Ga-68 agents and future innovations might encroach on Cu-64 Dotatate’s market.
• Reimbursement Fluctuations: Changes in healthcare policies could affect price sustainability.
• Manufacturing Bottlenecks: Scaling production to meet demand remains complex, especially for radiopharmaceuticals.

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Market Opportunities

• Expanding Indications: Beyond NETs, potential applications in neurodegenerative diseases or other receptor-targeted diagnostics.
• Partnerships and Licensing: Collaborations with global health entities and consortia could accelerate market access.
• Technological Synergies: Integration with advanced imaging systems and AI-enhanced diagnostics.

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Key Takeaways

• Cu-64 Dotatate holds strong potential to disrupt existing neuroendocrine tumor diagnostics, supported by its logistical and clinical advantages over Ga-68 agents.
• Its financial trajectory will hinge on successful regulatory approval, market acceptance, and reimbursement optimization.
• Long-term growth prospects are promising, fueled by increasing NET incidence, technological advancements, and broader adoption of PET imaging.
• Strategic partnerships and manufacturing scalability are vital to capitalize on market opportunities.
• Market risks necessitate vigilant navigation of regulatory, competitive, and logistical challenges.

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FAQs

1. When is Cu-64 Dotatate expected to receive regulatory approval?
Currently in clinical development phases, regulatory approval timelines depend on trial outcomes and agency review processes. If pivotal trials demonstrate safety and efficacy, approval could be anticipated within 2-3 years.

2. How does Cu-64 Dotatate compare to Ga-68 Dotatate in terms of clinical performance?
Studies suggest Cu-64 Dotatate offers superior tumor visualization due to its longer half-life, allowing for more flexible imaging schedules and broader distribution capacities, potentially improving diagnostic accuracy.

3. What are the advantages of Cu-64’s longer half-life for manufacturers?
The 12.7-hour half-life enables centralized manufacturing and wider distribution, reducing the need for on-site generators and expanding access—especially crucial for facilities lacking specialized infrastructure.

4. What pricing strategies are anticipated for Cu-64 Dotatate?
Pricing will likely mirror existing PET radiopharmaceuticals, between USD 3,000 and USD 5,000 per dose, influenced by manufacturing costs, reimbursement policies, and competitive dynamics.

5. What potential markets beyond neuroendocrine tumors could Cu-64 Dotatate address?
Future applications may include imaging of other receptor-expressing tumors, neurodegenerative disease diagnostics, or theranostic pairs when combined with therapeutic isotopes, expanding its market scope.

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References

[1] MarketWatch, "Neuroendocrine Tumors - Diagnostic Market Trends," 2022.
[2] ClinicalTrials.gov, "Efficacy of Cu-64 Dotatate in NET Imaging," 2021.
[3] PhRMA, "R&D Cost Analysis in Radiopharmaceutical Development," 2020.