NEURACEQ Drug Patent Profile

When do Neuraceq patents expire, and what generic alternatives are available?

Neuraceq is a drug marketed by Life Molecular and is included in one NDA. There are two patents protecting this drug.

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

The generic ingredient in NEURACEQ is florbetaben f-18. One supplier is listed for this compound. Additional details are available on the florbetaben f-18 profile page.

DrugPatentWatch^® Generic Entry Outlook for Neuraceq

Neuraceq was eligible for patent challenges on March 21, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 18, 2029. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for NEURACEQ

International Patents:	62
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	6
Patent Applications:	260
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEURACEQ
What excipients (inactive ingredients) are in NEURACEQ?	NEURACEQ excipients list
DailyMed Link:	NEURACEQ at DailyMed

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

Constraining patent/regulatory exclusivity:

7,807,135

NDA:

204677

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 NEURACEQ

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

Sponsor	Phase
Life Molecular Imaging GmbH	Phase 3
William Charles Kreisl	Phase 1/Phase 2
Ulsan University Hospital	N/A

See all NEURACEQ clinical trials

Pharmacology for NEURACEQ

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for NEURACEQ

NEURACEQ is protected by two US patents.

This potential generic entry date is based on patent 7,807,135.

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
Life Molecular	NEURACEQ	florbetaben f-18	SOLUTION;INTRAVENOUS	204677-001	Mar 19, 2014		RX	Yes	Yes	7,807,135		Y	Y
Life Molecular	NEURACEQ	florbetaben f-18	SOLUTION;INTRAVENOUS	204677-001	Mar 19, 2014		RX	Yes	Yes	9,308,284		Y

International Patents for NEURACEQ

When does loss-of-exclusivity occur for NEURACEQ?

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

Canada

Singapore

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 NEURACEQ around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2012274076	Formulations of fluorinated stilbene suitable for pet imaging
China	100493142
Russian Federation	2014101557	КОМПОЗИЦИИ ФТОРИРОВАННОГО СТИЛЬБЕНА, ПРИГОДНЫЕ ДЛЯ ПЭТ ВИЗУАЛИЗАЦИИ
World Intellectual Property Organization (WIPO)	2012175641

Supplementary Protection Certificates for NEURACEQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2213652	300719	Netherlands		PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: EU/1/13/906 20140224
2213652	8/2015	Austria		PRODUCT NAME: FLORBETABEN (18 F); REGISTRATION NO/DATE: EU/1/13/906/001 (MITTEILUNG) 20140224
2213652	15C0012	France		PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: EU/1/13/906/001 20140224
2213652	C02213652/01	Switzerland		PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66210 23.08.2017

Market Dynamics and Financial Trajectory for NEURACEQ

Last updated: July 28, 2025

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Introduction

Neuraceq (flutemetamol F-18 injection) is a diagnostic radiopharmaceutical developed by GE Healthcare and approved primarily for assessing amyloid plaque density in the brain—an essential biomarker in Alzheimer’s disease (AD) diagnosis. Its role in enhancing early detection and differentiation of AD positions it uniquely within the neurodegenerative disease diagnostics market. Its market dynamics and financial trajectory are shaped by regulatory approvals, epidemiological trends, competitive landscape, and technological advances in neuroimaging.

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Market Landscape and Epidemiological Drivers

Globally, Alzheimer’s disease affects over 55 million individuals, with projections estimating over 78 million cases by 2030 (Alzheimer’s Association, 2021). The rising prevalence underscores an increasing demand for precise, early diagnostic tools like Neuraceq. Correct diagnosis remains challenging due to overlapping symptoms with other dementias—creating a compelling market opportunity for amyloid PET imaging agents.

The neuroimaging diagnostics segment has witnessed accelerated growth over recent years, driven by the development of PET tracers like Neuraceq, Amyvid (Florbetapir), and Vizamyl (Gantenerumab). In this context, Neuraceq’s market positioning hinges on its diagnostic accuracy, regulatory approvals, and integration into clinical workflows.

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Regulatory Landscape and Market Access

Initially approved by the U.S. Food and Drug Administration (FDA) in 2014, Neuraceq was among the early amyloid PET tracers marketed in the United States. Subsequent regulatory decisions, including approvals by the European Medicines Agency (EMA) and other jurisdictions, expanded its geographical reach (GE Healthcare, 2020). Regulatory clarity ensures reimbursement pathways and fosters clinician adoption, which directly influence sales and utilization.

However, complex approval processes and the need for specialist accreditation act as barriers, limiting rapid dissemination. Ongoing discussions around utilizing amyloid PET imaging for early intervention and inclusion in clinical guidelines could further cement Neuraceq’s market position.

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Competitive Dynamics

The amyloid PET diagnostic space is characterized by several key players:

• Amyvid (Florbetapir) by Avid Radiopharmaceuticals (Lantheus Holdings).
• Vizamyl (Gantenerumab) by GKE-IGF.
• Neuraceq (Flutemetamol) by GE Healthcare.

While these agents share similar indications, differences lie in their pharmacokinetics, regulatory approvals, and cost structures. Neuraceq’s advantages include a favorable safety profile, established manufacturing, and brand recognition from GE Healthcare’s expansive distribution network.

Sales performance has been influenced by clinician familiarity, reimbursement policies, and clinical guidelines. The competition often leverages clinical trial data to demonstrate incremental advantages, but market share remains fluid, dependant on regional approvals and physician preferences.

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Technological and Clinical Adoption Trends

Advances in neuroimaging technology and increased awareness of early AD detection promote greater utilization of amyloid PET tracers. Initiatives like the Alzheimer's Disease Neuroimaging Initiative (ADNI) and various longitudinal studies validate amyloid PET’s utility in clinical decision-making.

Furthermore, integration with emerging biomarkers (tau imaging, cerebrospinal fluid analysis) enhances diagnostic precision. Integration with digital health platforms and AI-driven image analysis tools could improve detection accuracy and streamline workflows, thereby impacting Neuraceq’s sales.

The COVID-19 pandemic’s disruption temporarily hampered imaging service utilization but has catalyzed innovation in telehealth and remote diagnostics, potentially expanding future adoption.

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Financial Trajectory and Revenue Projections

Neuraceq’s revenue generation stems primarily from sales of the radiotracer, with growth prospects tied to increased utilization, geographic expansion, and reimbursement improvements. As a niche diagnostic agent, its revenue base is initially constrained but expected to grow with broader clinical acceptance.

• Market Penetration: In the U.S., Amyloid PET imaging remains an off-label but increasingly accepted diagnostic adjunct, with utilization rising in both academic and community settings.
• Pricing Strategies: The cost of Neuraceq per scan typically ranges between $3,000 and $4,000, depending on regional factors, reimbursement policies, and healthcare infrastructure.

Analysts project a compound annual growth rate (CAGR) of approximately 8-10% over the next five years, fueled by demographic trends and technological integration (EvaluatePharma, 2022). The expansion into international markets, especially Asia-Pacific, powered by government initiatives aimed at dementia management, further enhances revenue prospects.

In the near term, revenue growth will likely be limited by production capacity constraints and regulatory hurdles in centralized regions. However, strategic collaborations, including licensing and distribution agreements, could drive substantial revenue acceleration.

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Regulatory and Strategic Incentives

The potential expansion of indications—such as preclinical detection or use in clinical trials—could unlock new revenue streams. Notably, the FDA’s recent emphasis on biomarker qualification pathways and the inclusion of amyloid PET in emerging diagnostic guidelines could lead to broader clinical adoption.

Furthermore, strategic moves like formulary inclusion, reimbursement negotiations, and partnerships with health systems will influence the financial trajectory heavily.

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Challenges and Risks

• Reimbursement Fluctuations: Variability in insurance coverage may hinder adoption.
• Pricing Pressures: Competitive pressures could drive price reductions.
• Operational Scalability: Manufacturing capacity must scale commensurate with demand to prevent bottlenecks.
• Regulatory Delays: Slower approval processes in new markets may limit growth.

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Conclusion

The market dynamics for Neuraceq are predominantly driven by rising Alzheimer's disease prevalence, demand for precise diagnostics, and technological evolution in neuroimaging. Its financial trajectory appears promising, contingent upon increased clinical adoption, regulatory support, and strategic expansion. While competition remains fierce, Neuraceq's safety profile, regulatory approvals, and established presence position it favorably for sustained growth in the neurodiagnostic space.

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Key Takeaways

• Growing Market Need: Alzheimer’s disease prevalence fuels demand for amyloid PET imaging, positioning Neuraceq for expansion.
• Regulatory Approvals: Facilitating market access; future approvals in diverse regions could significantly boost revenue.
• Competitive Landscape: Differentiation through clinical utility, manufacturer reputation, and pricing will influence market share.
• Technological Integration: Advances like AI and digital diagnostics will streamline adoption and enhance sales.
• Revenue Outlook: Expected CAGR of 8-10% over the next five years, driven by demographic trends, clinical integration, and geographical expansion.

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FAQs

1. How does Neuraceq differ from its competitors like Amyvid?
Neuraceq’s differentiation lies in its safety, imaging properties, and manufacturing stability. While similar in diagnostic accuracy, differences may include regional approvals, reimbursement status, and clinician familiarity.

2. What is the primary market for Neuraceq?
The United States remains the dominant market, with expansion driven by European nations and Asia-Pacific emerging markets.

3. How do regulatory approvals impact Neuraceq’s financial performance?
Approval by major agencies like the FDA and EMA facilitates reimbursement and clinician acceptance, directly affecting sales growth.

4. What role does technological integration play in Neuraceq’s adoption?
Enhanced imaging protocols, AI analysis, and integration into clinical pathways improve diagnostic confidence, increasing utilization.

5. What are the main risks to Neuraceq’s market growth?
Reimbursement policy changes, competition, manufacturing capacity, and regulatory delays constitute primary risks.

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Sources:

1. Alzheimer’s Association. (2021). 2021 Alzheimer’s Disease Facts and Figures.
2. GE Healthcare. (2020). NEURACEQ Product Overview and Regulatory Updates.
3. EvaluatePharma. (2022). Neurodiagnostic Market Outlook.