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DETECTNET Drug Patent Profile

Which patents cover Detectnet, and when can generic versions of Detectnet launch?

Detectnet is a drug marketed by Radiomedix and is included in one NDA. There are four patents protecting this drug.

This drug has nineteen patent family members in twelve countries.

The generic ingredient in DETECTNET is copper cu-64 dotatate. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the copper cu-64 dotatate profile page.

DrugPatentWatch^® Generic Entry Outlook for Detectnet

Detectnet was eligible for patent challenges on September 3, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 3, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DETECTNET

International Patents:	19
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Drug Prices:	Drug price information for DETECTNET
What excipients (inactive ingredients) are in DETECTNET?	DETECTNET excipients list
DailyMed Link:	DETECTNET at DailyMed

See drug prices for DETECTNET

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DETECTNET

Constraining patent/regulatory exclusivity:

FOR USE WITH POSITRON EMISSION TOMOGRAPHY (PET) FOR LOCALIZATION OF SOMATOSTATIN RECEPTOR POSITIVE NEUROENDOCRINE TUMORS (NETS) IN ADULT PATIENTS

NDA:

213227

Dosage:

SOLUTION;INTRAVENOUS

^*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 DETECTNET

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

Sponsor	Phase
University of Wisconsin, Madison	Phase 1

See all DETECTNET clinical trials

Pharmacology for DETECTNET

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for DETECTNET

DETECTNET is protected by four US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on FOR USE WITH POSITRON EMISSION TOMOGRAPHY (PET) FOR LOCALIZATION OF SOMATOSTATIN RECEPTOR POSITIVE NEUROENDOCRINE TUMORS (NETS) IN ADULT PATIENTS.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	10,159,759
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	10,383,961
Radiomedix	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227-001	Sep 3, 2020		RX	Yes	Yes	11,160,888
Radiomedix	DETECTNET	copper cu-64 dotatate	SOLUTION;INTRAVENOUS	213227-001	Sep 3, 2020		RX	Yes	Yes

International Patents for DETECTNET

See the table below for patents covering DETECTNET around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013029616
Poland	3536346
South Korea	20230066382
China	116583527
Denmark	2750717

DETECTNET Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Detectnet (Copper Cu 64 Dotatate Injection)

Introduction to Detectnet

Detectnet, a positron emission tomography (PET) agent, was approved by the U.S. Food and Drug Administration (FDA) in September 2020 for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients. This approval marked a significant milestone in the diagnosis and treatment of neuroendocrine tumors, and it has had a profound impact on the market dynamics and financial trajectory of this drug.

Market Demand and Expansion

The demand for Detectnet has been robust since its approval. The drug's clinical sensitivity and specificity, as demonstrated in Phase III results, have made it a valuable tool for clinicians in developing accurate treatment plans for NET patients[2][4].

To meet this demand, Curium, the commercial partner of RadioMedix, announced a significant increase in the production capacity of Detectnet. Starting from May 2022, Curium began offering 50% more doses for patient use, Monday through Friday, to accommodate the growing market needs[1].

Production and Distribution Capabilities

Curium's unique production capabilities and extensive distribution network have been crucial in ensuring the widespread availability of Detectnet. The drug's 12.7-hour half-life allows for central production and shipment to various sites across the U.S., mitigating shortages and delays that were common with other somatostatin analogue PET agents[2][4].

This logistical advantage has provided scheduling flexibility to healthcare institutions and patients, further enhancing the drug's market appeal.

Financial Viability

The economic viability of Detectnet is closely tied to its market demand and the costs associated with its development and production. The pharmaceutical industry, particularly investor-owned companies, prioritizes drugs that have the potential for significant financial returns. Detectnet, being the first commercially available Cu 64 diagnostic agent, fits well into this model due to its high efficacy and the growing need for accurate diagnostics in neuroendocrine tumors[3].

Cost Considerations

The development of Detectnet involved substantial costs, including those related to clinical trials, regulatory approvals, and production setup. However, the anticipated returns on investment are significant, given the drug's critical role in diagnosing and managing NETs. The FDA approval and subsequent market launch have likely generated substantial revenue for Curium and RadioMedix, contributing positively to their financial trajectories[2][4].

Revenue Projections

While exact revenue figures for Detectnet are not publicly disclosed, the increased production capacity and expanded distribution indicate a strong revenue growth potential. The drug's ability to alleviate shortages and delays in diagnostic procedures for NETs has positioned it as a market leader, likely driving up sales and revenue.

Regulatory Environment

The regulatory environment has been favorable for Detectnet. The FDA approval in 2020 was a critical milestone, and the agency's ongoing support for innovative diagnostic agents has helped in the drug's market penetration. The Prescription Drug User Fee Act (PDUFA) and other regulatory frameworks have ensured a predictable and efficient review process, which has been beneficial for the drug's development and commercialization[5].

Risk and Safety Considerations

Like all diagnostic radiopharmaceuticals, Detectnet carries a radiation risk. Ensuring safe handling and preparation procedures is crucial to protect patients and healthcare workers from unintentional radiation exposure. Despite these risks, the drug's benefits in accurately localizing somatostatin receptor positive NETs have outweighed the risks, contributing to its strong market position[1][2][4].

Market Competition

Detectnet operates in a niche market focused on neuroendocrine tumors, where it has established itself as a leading diagnostic tool. The unique characteristics of the drug, including its long half-life and high clinical sensitivity, have differentiated it from other somatostatin analogue PET agents. This differentiation has helped in minimizing competition and securing a strong market share[2][4].

Future Outlook

The future outlook for Detectnet is promising. With continued advancements in nuclear medicine and the growing awareness of neuroendocrine tumors, the demand for accurate diagnostic tools is expected to increase. Curium's commitment to expanding production capacity and improving distribution logistics will likely support this growth.

Expanding Indications

There is potential for Detectnet to be explored for additional indications beyond its current use in NETs. Further research and clinical trials could expand its application, thereby increasing its market reach and financial potential.

Technological Advancements

Advancements in PET technology and imaging techniques could further enhance the efficacy and accessibility of Detectnet. These technological improvements could lead to better patient outcomes and increased adoption rates, contributing to the drug's long-term financial success.

Key Takeaways

• Strong Market Demand: Detectnet has seen significant demand since its FDA approval, driven by its clinical sensitivity and specificity.
• Increased Production: Curium has increased production capacity to meet market needs, ensuring wider availability.
• Financial Viability: The drug's high efficacy and market demand make it a financially viable product with strong revenue potential.
• Regulatory Support: Favorable regulatory environments have supported the drug's development and commercialization.
• Risk Management: While there are radiation risks, the benefits of Detectnet in diagnosing NETs outweigh these risks.
• Market Differentiation: Detectnet's unique characteristics have differentiated it from competitors, securing a strong market position.

FAQs

What is Detectnet used for?

Detectnet is a positron emission tomography (PET) agent used for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.

Who are the key players involved in the development and commercialization of Detectnet?

RadioMedix Inc. and Curium are the key players involved in the development and commercialization of Detectnet.

What is the significance of Detectnet's 12.7-hour half-life?

The 12.7-hour half-life of Detectnet allows for central production and shipment to various sites, alleviating shortages and delays common with other somatostatin analogue PET agents.

What are the potential risks associated with Detectnet?

Detectnet, like other diagnostic radiopharmaceuticals, carries a radiation risk. Safe handling and preparation procedures are essential to protect patients and healthcare workers.

How has the market responded to Detectnet since its FDA approval?

The market has responded positively to Detectnet, with significant demand leading to an increase in production capacity to meet the growing needs of healthcare providers and patients.

Sources

1. Curium Announces Significant Increase in Detectnet™ (copper Cu 64 dotatate injection) Production Capacity. Biospace.
2. RadioMedix and Curium Announce FDA Approval of Detectnet™ (copper Cu 64 dotatate injection) in the U.S.. RadioMedix.
3. A Drug's Journey from Targets to Markets: Druggability, Economic Viability, and Gateways to Human Testing. PharmaFeatures.
4. RadioMedix and Curium Announce FDA Approval of Detectnet™ (copper Cu 64 dotatate injection) in the U.S.. Curium Pharma.
5. FY 2020 PDUFA Performance Report. FDA.