Florbetaben f-18 - Generic Drug Details

What are the generic 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 Lantheus 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
Lantheus	NEURACEQ	florbetaben f-18	SOLUTION;INTRAVENOUS	204677-001	Mar 19, 2014		RX	Yes	Yes			Y
Lantheus	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
Spain	2683818
Brazil	PI0516408	derivados de estilbeno e seu uso para ligação e formação de imagem de placas de amilóide
Portugal	2213652

Supplementary Protection Certificates for florbetaben f-18

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2213652	C20150010 00142	Estonia		PRODUCT NAME: FLORBETABEEN (18F);REG NO/DATE: EU/1/13/906 24.02.2014
2213652	300719	Netherlands		PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: EU/1/13/906 20140224
2213652	PA2015005,C2213652	Lithuania		PRODUCT NAME: FLORBETABENAS (18F); REGISTRATION NO/DATE: EU/1/13/906/001 20140220

Market Dynamics and Financial Trajectory for Florbetaben F-18

Last updated: February 20, 2026

Overview
Florbetaben F-18 is a radioactive diagnostic agent used in positron emission tomography (PET) imaging to detect beta-amyloid plaques associated with Alzheimer’s disease. Approved by the FDA in 2014 under the trade name Neuraceq, it forecasts a growing footprint driven by dementia diagnosis needs, technological advancements, and expanding clinical applications.

Market Drivers

Growing Burden of Alzheimer’s Disease

The global prevalence of Alzheimer’s, projected to exceed 152 million by 2050 (Alzheimer’s Association, 2021), increases demand for diagnostic tools. Early and accurate detection enhances treatment planning, fostering market growth for amyloid PET agents.

Advances in Neuroimaging Technology

Enhanced imaging resolution and broader accessibility of PET scanners facilitate wider deployment. FDA and EMA approvals for amyloid imaging agents, including florbetaben, support clinical adoption and reimbursement policies.

Regulatory Approvals & Reimbursement Policies

Reimbursement coverage varies by country. In the U.S., Medicare covers amyloid PET imaging, including florbetaben, since 2013, with coverage expansion in subsequent years. Europe’s approvals differ by jurisdiction, affecting deployment speed.

Competitive Landscape

Florbetaben faces competition from similar agents like florbetapir (Amyvid) and flutemetamol (Vizamyl). Each has distinct approval timelines, commercialization strategies, and market shares influencing florbetaben’s financial prospects.

Market Size & Forecasts

Parameter	Data	Source
2022 global amyloid PET market size	$700 million	MarketsandMarkets (2022)
2027 projected market size	$1.4 billion	MarketsandMarkets (2022)
Compound Annual Growth Rate (CAGR)	15.0% (2022–2027)	MarketsandMarkets (2022)
Florbetaben market share (estimated)	25–30% within amyloid PET segment	Industry analysts (2023)

Florbetaben’s market share depends on adoption rates, reimbursement, and competitor activity, with a potential for incremental gains as clinical protocols evolve.

Revenue & Financial Trajectory

Revenue Estimations (2023–2028)

Assuming initial global sales of approximately $200 million in 2023 (based on current market penetration), with a 15% CAGR driven by increased adoption:

Year	Estimated Revenue (USD millions)	Assumptions
2023	200	Current sales, steady market penetration
2024	230	Slight market share increase, expanded reimbursement
2025	265	Broadened clinical indications, new markets
2026	305	Greater regional adoption, technological improvements
2027	351	Continued growth, increased use in diagnostics
2028	404	Market expansion, potential new indications

Cost Structure & Pricing Dynamics

Average price per dose varies by country—estimated at $300–$600. Cost components include isotope production (~$150), manufacturing, distribution, and regulatory compliance. Margins depend heavily on volume and reimbursement reimbursement levels.

Key Revenue Contributors

1. North America (70%) of sales due to high adoption and reimbursement coverage.
2. Europe (20%) with gradual uptake, influenced by regional approvals.
3. Asia-Pacific (10%) with emerging opportunities, constrained by regulatory timelines.

Risks & Market Barriers

• Regulatory Delays: Market entry slows with approval processes in developing markets.
• Reimbursement Challenges: Limited coverage could restrain adoption.
• Competition: Fluctuations in market shares from other amyloid PET tracers influence overall revenue.
• Technological Evolution: Preference for alternative imaging or diagnostics could curtail demand.

Strategic Opportunities

• Expansion into research use only (RUO) markets for early-phase clinical trials.
• Development of complementary diagnostics, such as tau PET imaging.
• Partnership with imaging centers and healthcare providers to promote usage.

Key Takeaways

• Florbetaben F-18 is positioned within a rapidly expanding amyloid PET imaging segment driven by aging demographics and technological integration.
• Expect a CAGR around 15% through 2027, with revenue potentially surpassing $400 million by 2028.
• Growth hinges on regulatory approvals, reimbursement policies, and competitive positioning among amyloid tracers.
• Regional disparities in adoption influence global revenues, with North America leading.
• Market sensitivity to medical innovation and healthcare policy shifts necessitates continuous strategic monitoring.

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FAQs

1. How does florbetaben F-18 compare to other amyloid PET tracers?
It offers similar diagnostic performance but may differ in approval status, reimbursement, and regional availability.

2. What are the main factors influencing florbetaben sales growth?
Reimbursement coverage, physician adoption, technological advances, and clinical guideline integration.

3. Are there any upcoming regulatory changes affecting florbetaben?
Potential approvals in Asian markets and updates in European guidelines may impact future sales.

4. How significant are manufacturing costs for florbetaben?
Isotope production (~$150/dose) is a primary cost driver; economies of scale can improve margins over time.

5. What potential does florbetaben have in early Alzheimer’s diagnosis?
Its ability to detect amyloid plaques before clinical symptoms suggest significant growth in early diagnostic applications.

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References

[1] Alzheimer’s Association. (2021). 2021 Alzheimer’s disease facts and figures. Alzheimer’s & Dementia, 17(3), 327–406.
[2] MarketsandMarkets. (2022). Amyloid PET imaging market size, share, growth.
[3] FDA. (2014). Neuraceq (florbetaben) FDA approval documentation.
[4] European Medicines Agency. (2015). Vizamyl (flutemetamol) approval details.