Florbetaben f-18 - Generic Drug Details

What are the generic drug sources for florbetaben f-18 and what is the scope of freedom to operate?

Florbetaben f-18 is the generic ingredient in one branded drug marketed by Life Molecular and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Florbetaben f-18 has sixty-two patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for florbetaben f-18

International Patents:	62
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	26
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for florbetaben f-18
DailyMed Link:	florbetaben f-18 at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for florbetaben f-18

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 florbetaben f-18

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

Sponsor	Phase
pharmtrace	PHASE1
Life Molecular Imaging GmbH	PHASE1
ChenXiaoChun	PHASE2

See all florbetaben f-18 clinical trials

Pharmacology for florbetaben f-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for florbetaben f-18

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			Y
Life Molecular	NEURACEQ	florbetaben f-18	SOLUTION;INTRAVENOUS	204677-001	Mar 19, 2014		RX	Yes	Yes			Y	Y

International Patents for florbetaben f-18

Country	Patent Number	Title	Estimated Expiration
Australia	2012274076	Formulations of fluorinated stilbene suitable for pet imaging
Portugal	2213652
Netherlands	300719
Brazil	112013032610	formulações de estilbeno fluorado adequadas para imagiologia pet
Poland	2723394

Supplementary Protection Certificates for florbetaben f-18

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
2213652	1590005-3	Sweden		PRODUCT NAME: FLORBETABEN (18F); REG. NO/DATE: EU/1/13/906 20140224

Market Dynamics and Financial Trajectory for Florbetaben F-18

Last updated: July 28, 2025

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Introduction

Florbetaben F-18 is a radioactive diagnostic agent primarily used for positron emission tomography (PET) imaging to detect amyloid plaques associated with Alzheimer's disease. As the prevalence of neurodegenerative disorders escalates globally, the demand for advanced diagnostic tools like florbetaben F-18 is gaining momentum. This comprehensive analysis evaluates the current market dynamics, growth drivers, challenges, and financial prospects associated with florbetaben F-18 over the next decade.

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Market Overview and Functional Landscape

Florbetaben F-18, branded commercial formulations like Amyvid, was developed to improve early diagnosis and management of Alzheimer's disease (AD). Its unique ability to visualize amyloid beta plaques positions it as a cornerstone in neurodegenerative diagnostics. The compound's approval by regulatory agencies such as the FDA (2012) marked a significant milestone, opening new avenues for PET imaging in neurology.

The global neuroimaging market is expanding rapidly, driven by technological advancements and increased clinical adoption, with the PET imaging segment leading this growth. Florbetaben F-18’s utility complements existing diagnostic tools, enhancing diagnostic accuracy for AD and other amyloid-related disorders.

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Market Dynamics

Driving Factors

1. Rising Prevalence of Alzheimer's Disease and Neurodegenerative Disorders

The World Alzheimer Report 2019 estimates that over 50 million people worldwide suffer from dementia, with AD accounting for approximately 60-70% of cases. Such prevalence propels the demand for precise diagnostic tools to facilitate early intervention. Early diagnosis can improve patient outcomes and reduce healthcare burdens.

2. Advancements in PET Imaging Technology

Innovations in PET imaging enhance resolution and reduce scan times, making amyloid PET scans more accessible and reliable. Florbetaben F-18's compatibility with existing PET infrastructure accelerates its clinical adoption.

3. Regulatory Approvals and Reimbursement Policies

The FDA’s approval in 2012 and subsequent European CE marking widened the market scope. Increasing acceptance by healthcare payers and inclusion in clinical guidelines further reinforce utilization, translating into enhanced sales trajectories.

4. Growing Awareness and Physician Adoption

Educational initiatives and clinical research supporting amyloid imaging emphasize its role in dementia diagnosis. This knowledge dissemination fosters increased demand among neurologists and imaging centers.

Constraints and Challenges

1. High Cost and Limited Accessibility

Despite its diagnostic advantages, florbetaben F-18 remains expensive owing to production complexities, like the need for on-site cyclotrons or nearby radiopharmacies. These logistical constraints limit widespread adoption, especially in low-resource settings.

2. Short Half-Life and Logistics Complexities

The 110-minute half-life of F-18 necessitates rapid synthesis and distribution, imposing operational challenges, particularly in regions lacking infrastructure. This limits rapid market penetration in emerging economies.

3. Competition from Alternative Modalities

Emerging imaging agents, such as florbetapir (Amyvid) and flutemetamol, alongside non-invasive biomarkers, pose competitive threats. Furthermore, ongoing research into blood-based biomarkers may eventually reduce reliance on PET imaging.

4. Limited Indications and Clinical Guidelines

Currently, florbetaben F-18's primary indication is amyloid imaging in cognitive decline. Broader indications await validation, restricting potential sales expansion in other neurological or psychiatric conditions.

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Financial Trajectory

Current Market Size and Revenue Potential

In 2022, the global market for amyloid PET tracers, including florbetaben F-18, valuation was approximately USD 350 million, with projections to reach USD 600 million by 2030, CAGR (Compound Annual Growth Rate) of about 7%. The growth is driven predominantly by North America and Europe, which together account for roughly 75% of the current sales.

Key Revenue Drivers

• Expanding Clinical Adoption: Increasing use in diagnosing early-stage AD and in clinical trials accelerates revenue streams.

• Clinical Research and Trials: Pharmaceutical companies deploying florbetaben F-18 in anti-amyloid therapeutic trials drive both volume and credibility, providing additional revenue streams.

• Geographic Expansion: Entry into emerging markets like Asia-Pacific, Latin America, and the Middle East offers considerable growth avenues due to rising healthcare infrastructure and dementia awareness.

Financial Challenges and Opportunities

Pricing Strategies:

The average price per PET scan involving florbetaben F-18 ranges between USD 2,000 and USD 4,000. Negotiations with payers and providers influence margins, with premium pricing justified by diagnostic accuracy.

Manufacturing and Supply Chain Costs:

Production costs are high, involving cyclotron facilities, quality control, and regulatory compliance. Investments in decentralized radiopharmacy networks and regional manufacturing can improve margins.

Market Penetration and Competition:

Competitive pressures from other tracers and emerging blood biomarkers could suppress growth unless florbetaben F-18 emphasizes its diagnostic superiority or cost advantages.

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Regulatory and Market Expansion Strategies

Regulatory approvals in additional geographies, including Asia and Latin America, will significantly enhance market potential. Tailoring distribution channels, investing in manufacturing capacity, and engaging in payor negotiations are essential to capitalize on these markets.

Furthermore, integrating florbetaben F-18 into multimodal dementia diagnostic algorithms enhances clinical utility, promoting broader acceptance.

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Future Outlook and Investment Themes

The future trajectory hinges on several elements:

• Technological Advances: Enhanced scanner resolution and novel tracers could either complement or challenge florbetaben F-18’s market share.
• Regulatory Milestones: Approval for formal inclusion in diagnostic guidelines will catalyze demand.
• Biomarker Integration: Blood-based biomarkers may supplement or replace PET imaging, influencing long-term revenues.
• Research & Development: Innovations targeting other amyloid-related and tauopathies open avenues for line extensions or new indications.

Investors and stakeholders should closely monitor advancements in neuroimaging, shifts in clinical guidelines, and reimbursement policies in key markets.

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Key Takeaways

• The global florbetaben F-18 market is poised for sustained growth, driven by rising dementia prevalence, technological advancements, and expanding clinical acceptance.
• High costs, logistical constraints, and competition from alternative diagnostic modalities pose significant challenges.
• Market expansion into emerging economies presents lucrative opportunities, assuming infrastructural hurdles are addressed.
• Strategic partnerships, regional manufacturing, and clinical guideline integration are essential to optimize financial outcomes.
• Innovations in biomarker research and neuroimaging will influence long-term market dynamics, necessitating continuous adaptation.

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FAQs

1. What is florbetaben F-18, and how does it work in diagnosing Alzheimer's disease?
Florbetaben F-18 is a radiotracer used in PET scans to visualize amyloid beta plaques in the brain. Its binding to amyloid deposits allows clinicians to detect and quantify amyloid burden, aiding in the early diagnosis of Alzheimer's disease (AD) and differentiating it from other causes of dementia.

2. What are the main market drivers for florbetaben F-18?
The primary drivers include the rising prevalence of AD, technological advancements in PET imaging, regulatory approvals, increasing clinical awareness, and expanding reimbursement coverage in mature markets.

3. What are the key challenges limiting the market growth of florbetaben F-18?
High costs, logistical complexities due to its short half-life, competition from other tracers and blood biomarkers, limited indications, and infrastructural barriers in certain regions hinder widespread adoption.

4. How is the market size expected to evolve over the next decade?
The amyloid PET tracer market, including florbetaben F-18, is projected to grow at approximately 7% CAGR, reaching around USD 600 million globally by 2030, driven by increased clinical use and geographic expansion.

5. What strategic actions can companies take to capitalize on this market?
Companies should focus on expanding manufacturing capacity, securing regulatory approvals in emerging markets, strengthening partnerships with healthcare providers, and investing in clinical research that broadens indications.

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Sources:

1. World Alzheimer Report 2019. Alzheimer's Disease International.
2. FDA approval documentation for florbetaben (Amyvid).
3. Global neuroimaging market analysis reports, 2022-2030.
4. Industry insights on PET imaging and amyloid tracers.
5. Market research on diagnostic imaging and neurodegenerative disorder diagnostics.