NETSPOT Drug Patent Profile

Which patents cover Netspot, and what generic alternatives are available?

Netspot is a drug marketed by Aaa Usa Inc and is included in one NDA. There is one patent protecting this drug.

This drug has thirty-two patent family members in nineteen countries.

The generic ingredient in NETSPOT is gallium dotatate ga-68. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the gallium dotatate ga-68 profile page.

DrugPatentWatch^® Generic Entry Outlook for Netspot

Netspot was eligible for patent challenges on June 1, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 10, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for NETSPOT

International Patents:	32
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	5
Drug Prices:	Drug price information for NETSPOT
What excipients (inactive ingredients) are in NETSPOT?	NETSPOT excipients list
DailyMed Link:	NETSPOT at DailyMed

See drug prices for NETSPOT

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

Constraining patent/regulatory exclusivity:

9,375,498

NDA:

208547

Dosage:

POWDER;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 NETSPOT

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

Sponsor	Phase
RayzeBio, Inc.	Phase 2
Hoag Memorial Hospital Presbyterian	Phase 2
Assistance Publique - Hôpitaux de Paris	Phase 3

See all NETSPOT clinical trials

US Patents and Regulatory Information for NETSPOT

NETSPOT is protected by one US patents.

This potential generic entry date is based on patent 9,375,498.

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
Aaa Usa Inc	NETSPOT	gallium dotatate ga-68	POWDER;INTRAVENOUS	208547-001	Jun 1, 2016		RX	Yes	Yes	9,375,498		Y

International Patents for NETSPOT

When does loss-of-exclusivity occur for NETSPOT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Colombia

Denmark

European Patent Office

India

Israel

Italy

Japan

Mexico

New Zealand

Poland

Portugal

Russian Federation

South Africa

Spain

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

See the table below for additional patents covering NETSPOT around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2014524423
Mexico	2014001691	PROCEDIMIENTO PARA LA PREPARACION DE COMPLEJOS DE 68GA. (PROCESS FOR THE PREPARATION OF COMPLEXES OF 68GA.)
South Africa	201401789	PROCESS FOR THE PREPARATION OF COMPLEXES OF 68GA
Italy	FI20110180	PROCESSO PER LA PREPARAZIONE DI COMPLESSI DI 68GA.
Spain	2835581

Market Dynamics and Financial Trajectory for NETSPOT

Introduction

NETSPOT, a kit for the preparation of gallium-68 dotatate injection, has revolutionized the diagnosis of neuroendocrine tumors (NETs) since its approval by the U.S. Food and Drug Administration (FDA) in 2016. Here, we delve into the market dynamics and financial trajectory of this innovative diagnostic tool.

Market Need and Indications

NETSPOT is indicated for use with positron emission tomography (PET) to localize somatostatin receptor-positive NETs in adult and pediatric patients. This fills a critical gap in the diagnosis of NETs, which are diverse and often challenging to detect and manage[4][5].

Incidence of NETs

The incidence of NETs is significant, with approximately 47,300 new cases estimated annually in the combined populations of the United States and the European Union. This demand drives the need for accurate and reliable diagnostic tools like NETSPOT[3].

Regulatory Approvals

NETSPOT received FDA approval following a Priority Review, highlighting its importance in addressing unmet medical needs. This approval was a milestone for Advanced Accelerator Applications S.A. (AAA), now part of Novartis, and marked the first FDA-approved drug using gallium-68 as a positron emitter[4].

Market Adoption and Usage

Since its approval, NETSPOT has seen significant adoption. The number of NETSPOT scans has been increasing, partly due to its ease of use and the growing awareness of its diagnostic capabilities. For instance, in 2019, an estimated 40,000 NETSPOT doses were sold, indicating a substantial market penetration[1].

Clinical Impact

The clinical impact of NETSPOT is substantial. It allows for precise localization of NETs, which is crucial for determining the appropriate treatment, including targeted therapies like Lutathera. Studies have shown that patients who undergo NETSPOT scans have a higher likelihood of qualifying for targeted radiation therapies, thereby improving treatment outcomes[2][3].

Financial Performance

The financial performance of NETSPOT has been robust. Here are some key financial indicators:

Revenue Growth

AAA reported significant revenue growth in the years leading up to and following the approval of NETSPOT. For example, sales increased from €69.9 million in 2014 to €88.6 million in 2015, and further to €54.6 million for the first half of 2016 alone[3][4].

Sales Projections

The market for NETSPOT is expected to continue growing. With the increasing adoption of targeted radiotherapies and the expanding use of NETSPOT for diagnostic purposes, sales are projected to rise. For instance, the overall nuclear medicine market, of which NETSPOT is a part, is expected to see substantial growth, with targeted radiotherapies like Lutathera driving a significant portion of this growth[1].

Competitive Landscape

The competitive landscape for NETSPOT is favorable due to its unique positioning as the first FDA-approved drug using gallium-68. AAA, now part of Novartis, holds a leadership position in nuclear medicine diagnostics in Europe and is expanding its presence globally. The Orphan Drug Designation for NETSPOT from both the FDA and the European Medicines Agency further enhances its market exclusivity[4].

Barriers to Entry

High entry barriers in the nuclear medicine sector, including stringent regulatory requirements and the need for specialized manufacturing and distribution capabilities, protect NETSPOT's market position. This makes it challenging for new competitors to enter the market, thereby securing NETSPOT's dominance[1].

Integration with Therapeutic Options

NETSPOT is closely integrated with therapeutic options like Lutathera, another product from the same company. Lutathera, a Lu-177-labeled analogue of somatostatin, is used to treat gastroenteropancreatic NETs. The combination of NETSPOT for diagnosis and Lutathera for treatment creates a comprehensive solution for NET patients, enhancing the overall market potential of both products[2][3].

Synergistic Effects

The synergistic effect between NETSPOT and Lutathera is evident in the increased number of patients qualifying for Lutathera treatment following a NETSPOT scan. This integration not only improves patient outcomes but also drives sales for both products. For example, in 2019, it was estimated that only about 14% of patients who received a NETSPOT scan were treated with Lutathera, indicating room for growth as more hospitals and clinics adopt these technologies[1].

Future Outlook

The future outlook for NETSPOT is promising, driven by several factors:

Expanding Indications

The potential for NETSPOT to be used in broader indications, such as prostate cancer, is significant. While current use is primarily for NETs, the technology could be adapted for other tumor types, expanding its market reach[1].

Market Growth Projections

The nuclear medicine market, particularly the segment focused on targeted radiotherapies, is expected to grow substantially. By 2030, targeted radiotherapies are projected to account for 70% of the $30 billion nuclear medicine market, with NETSPOT playing a crucial role in this growth[1].

Technological Advancements

Continuous technological advancements in PET imaging and radiopharmaceuticals will further enhance the diagnostic capabilities of NETSPOT, potentially leading to increased adoption and market share.

Key Takeaways

• Regulatory Approval: NETSPOT received FDA approval in 2016, marking a significant milestone in the diagnosis of NETs.
• Market Adoption: The number of NETSPOT scans has been increasing, driven by its diagnostic accuracy and ease of use.
• Financial Performance: NETSPOT has contributed to significant revenue growth for AAA and Novartis.
• Integration with Therapeutics: The combination of NETSPOT with Lutathera enhances patient outcomes and drives sales for both products.
• Future Outlook: The market for NETSPOT is expected to grow, driven by expanding indications and technological advancements.

FAQs

What is NETSPOT used for?

NETSPOT is used with positron emission tomography (PET) for the localization of somatostatin receptor-positive neuroendocrine tumors (NETs) in adult and pediatric patients.

When was NETSPOT approved by the FDA?

NETSPOT was approved by the FDA in June 2016 following a Priority Review.

How does NETSPOT integrate with Lutathera?

NETSPOT is used for diagnosing NETs, and patients who undergo NETSPOT scans may qualify for treatment with Lutathera, a targeted radiation therapy.

What are the financial projections for NETSPOT?

The sales of NETSPOT are expected to rise as part of the growing nuclear medicine market, particularly in the segment of targeted radiotherapies.

What are the barriers to entry for competitors in the NETSPOT market?

High entry barriers include stringent regulatory requirements, specialized manufacturing, and distribution capabilities, making it challenging for new competitors to enter the market.

Sources

1. Eckert & Ziegler AG: Hauck & Aufhäuser Privatbankiers AG, "Eckert & Ziegler AG," March 10, 2021.
2. Radiology Key: "Neuroendocrine Tumor Imaging and Therapy," June 23, 2022.
3. J.P. Morgan: Advanced Accelerator Applications S.A., "Advanced Accelerator Applications S.A.," October 4, 2016.
4. Biospace: Advanced Accelerator Applications Applications, "Advanced Accelerator Applications Announces FDA Approval of NETSPOT," June 2, 2016.
5. Novartis: "NETSPOT®," October 2023.