NETSPOT Drug Patent Profile

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

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

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
Hoag Memorial Hospital Presbyterian	Phase 2
RayzeBio, Inc.	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.

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			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
Portugal	2742017
Mexico	370081	PROCEDIMIENTO PARA LA PREPARACION DE COMPLEJOS DE 68GA. (PROCESS FOR THE PREPARATION OF COMPLEXES OF 68GA.)
Japan	6161610

Market Dynamics and Financial Trajectory for NETSPOT (Gallium (^68Ga) Pseda): An In-Depth Analysis

Last updated: July 28, 2025

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Introduction

NETSPOT (Gallium (^68Ga) PSMA-11) stands out as a radiopharmaceutical agent designed for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-expressing prostate cancer lesions. Approved by the U.S. Food and Drug Administration (FDA) in 2020, NETSPOT represents a pivotal advancement in prostate cancer diagnostics, addressing a significant unmet clinical need for accurate staging and recurrence detection. Understanding its market dynamics and financial trajectory involves examining regulatory landscapes, technological trends, competitive environment, and healthcare adoption patterns.

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Regulatory Backdrop and Market Penetration

The FDA's approval marked a turning point, legitimizing NETSPOT’s role in prostate cancer imaging and catalyzing broader clinical adoption. Regulatory validation fosters confidence among providers and payers, supporting reimbursement pathways and thereby influencing sales growth. Similarly, European and Asian regulatory approvals expand its accessible markets, though regional disparities exist based on local acceptance of radiopharmaceuticals and healthcare infrastructure.

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Market Size and Growth Drivers

The global prostate cancer diagnostics market, valued at approximately USD 1.7 billion in 2022, is projected to surpass USD 4 billion by 2030, with imaging agents like NETSPOT contributing significantly (source: Grand View Research). Several key factors drive this growth:

• Rising Incidence of Prostate Cancer: Globally, prostate cancer is the second most common cancer among men, with over 1.4 million new cases annually (GLOBOCAN 2020). Early detection and precise tumor localization are crucial, amplifying demand for advanced imaging modalities.

• Limitations of Conventional Imaging: Traditional techniques like CT, MRI, and bone scans often lack specificity in detecting prostate cancer metastasis or recurrence. PSMA-PET imaging, including NETSPOT, offers higher sensitivity and specificity, making it clinically advantageous.

• Shift Toward Personalized Medicine: The move toward tailored treatment planning enhances the value proposition of PSMA-targeted imaging, prompting broader clinician adoption.

• Reimbursement Expansion: As healthcare systems recognize the clinical benefits, reimbursement policies progressively favor advanced imaging, though variability remains across regions.

Competitive Landscape

While NETSPOT is a leading agent for PSMA PET imaging, competitors and pipeline products influence market trajectory:

• Others in the Market: ^18F-PSMA compounds (e.g., PyL by 18F-DCFPyL) are emerging, offering logistical advantages due to longer half-lives, facilitating broader distribution.

• Alternative Imaging: Conventional agents and MRI techniques remain in use, with NETSPOT targeting niches where superior specificity is critical.

• Distribution and Production: The short half-life (~68 minutes) of Gallium-68 necessitates on-site generators and specialized infrastructure, constraining scalability.

Pricing and Reimbursement Dynamics

Pricing strategies for NETSPOT are influenced by manufacturing costs, competitive positioning, and payer negotiations. The initial premium over conventional imaging reflects its clinical advantages. Reimbursement policies, particularly in the U.S., under Medicare and private insurers, have increasingly recognized PSMA-PET scans as reimbursable, with billing codes supporting revenue flows.

Adoption Challenges and Opportunities

Challenges:

• Operational Constraints: Short half-life requires proximity to production facilities, limiting accessibility in rural or resource-poor settings.

• Regulatory Variability: Approval delays and reimbursement hurdles differ globally.

• Market Hesitation: Limited clinician familiarity and logistical hurdles can slow adoption.

Opportunities:

• Expanding Clinical Evidence: Ongoing studies demonstrating improved outcomes bolster confidence.

• Increased Awareness: Education initiatives can accelerate adoption.

• Pipeline Expansion: Development of longer-lived isotopes and theranostic variants broadens scope.

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Financial Trajectory and Revenue Forecasts

The initial market for NETSPOT centers primarily on North America, where FDA approval and reimbursement facilitate sales expansion. As of 2022, sales are estimated in the hundreds of millions USD, with projections indicating rapid growth:

• 2023–2025: Compound annual growth rate (CAGR) expected to approximate 20-25%, driven by increased clinical adoption, geographic expansion, and reimbursement optimization.

• Long-Term Outlook: Market penetration is expected to reach over 50% among targeted prostate cancer imaging procedures in developed markets by 2030, projecting revenues exceeding USD 1 billion annually.

• Pricing Sensitivity: The trajectory depends on pricing strategies, reimbursement levels, and technology advancements. Efficient production and wider distribution are vital to scaling.

Strategic Factors Influencing Financial Outcomes

• Enhanced Production Capacity: Investment in generator infrastructure and partnerships with manufacturing entities will influence supply side.

• Regulatory Approvals in Emerging Markets: Accelerated approvals can significantly enlarge revenue streams.

• Pipeline Integration: Combining diagnostic and therapeutic agents (theranostics) creates cross-market opportunities, further elevating valuations.

• Partnerships and Licensing Agreements: Alliances with pharmaceutical and radiopharmaceutical firms facilitate market entry, expand reach, and accelerate revenue.

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Conclusion

NETSPOT’s market dynamics hinge on its clinical superiority, regulatory validation, and evolving healthcare paradigms favoring personalized, high-precision diagnostics. The trajectory is positively skewed, with substantial growth potential fueled by increasing prostate cancer prevalence, technological improvements, and expanding reimbursement landscapes. Nonetheless, operational hurdles related to isotope logistics, regional regulations, and market penetration pace warrant strategic navigation.

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Key Takeaways

• NETSPOT is positioned as a transformative diagnostic agent with significant growth potential within the prostate cancer imaging market.

• Regulatory approvals and reimbursement support facilitate market expansion, with North America at the forefront.

• Competition from alternative isotopes and logistical complexities remain hurdles, but ongoing pipeline innovations and pipeline expansion mitigate these concerns.

• Revenue projections indicate a CAGR of approximately 20-25% over the next several years, with long-term revenues surpassing USD 1 billion.

• Strategic investments in production capacity, global regulatory strategy, and clinician education are critical to maximizing financial trajectory.

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FAQs

1. How does NETSPOT’s clinical efficacy compare to traditional prostate cancer imaging methods?
NETSPOT offers higher sensitivity and specificity in detecting prostate cancer metastases, especially in identifying small or early lesions, outperforming conventional bone scans and MRI in many clinical scenarios.

2. What are the main logistical challenges associated with NETSPOT’s production and distribution?
Its short half-life (~68 minutes) requires installation of on-site ^68Ga generators, limiting supply chain flexibility and necessitating advanced infrastructure near production sites.

3. How is reimbursement influencing NETSPOT’s market growth?
Reimbursement approvals by Medicare and private insurers in key markets have significantly lowered financial barriers for providers, accelerating adoption and revenue generation.

4. What role do pipeline PSMA agents play in shaping NETSPOT’s market?
Longer-lived isotopes (e.g., ^18F compounds) promise broader distribution, reducing logistical barriers and competing for market share, thus influencing NETSPOT’s strategic positioning.

5. How significant is the geographical expansion potential for NETSPOT?
Growing approvals in Europe, Asia, and other regions present substantial growth opportunities, contingent on regional regulatory navigation and infrastructure development.

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References

1. Grand View Research. Prostate Cancer Diagnostics Market Size, Share & Trends Analysis Report. 2022.
2. GLOBOCAN 2020. Estimated Number of Incidence and Mortality Cases. IARC.
3. FDA. FDA approves first Gallium-68 (Ga-68) PSMA-11 PET imaging agent for men with prostate cancer. 2020.
4. MarketWatch. Prostate Cancer Imaging Market Report. 2023.
5. European Medicines Agency. Regulatory status of PSMA agents. 2022.