florbetaben f-18 - Profile

What are the generic sources for florbetaben f-18 and what is the scope of patent protection?

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.

Summary for florbetaben f-18

International Patents:	62
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for florbetaben f-18

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

Constraining patent/regulatory exclusivity:

9,308,284

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.

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

International Patents for florbetaben f-18

Country	Patent Number	Title	Estimated Expiration
Brazil	112013032610
Lithuania	C2213652
Spain	2683818
Spain	2526655
Canada	2839961
Mexico	344954	FORMULACIONES DE ESTILBENO FLUORADO ADECUADO PARA LA FORMACION DE IMAGENES PET. (FORMULATIONS OF FLUORINATED STILBENE SUITABLE FOR PET IMAGING.)
Japan	2008524243

Supplementary Protection Certificates for florbetaben f-18

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2213652	1590005-3	Sweden		PRODUCT NAME: FLORBETABEN (18F); REG. NO/DATE: EU/1/13/906 20140224
2213652	122015000018	Germany		PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: EU/1/13/906/001 20140220
2213652	8/2015	Austria		PRODUCT NAME: FLORBETABEN (18 F); REGISTRATION NO/DATE: EU/1/13/906/001 (MITTEILUNG) 20140224
2213652	SPC/GB15/010	United Kingdom		PRODUCT NAME: FLORBETABEN (18F), WHICH IS (4-((E)-2-(4-(2-(2-(2-(1F)FLUOROETHOXY)ETHOXY)ETHOXY)PHENYL)ETHENYL)-N-METHYLANILINE); REGISTERED: UK EU/1/13/906/001 20140224
2213652	PA2015005,C2213652	Lithuania		PRODUCT NAME: FLORBETABENAS (18F); REGISTRATION NO/DATE: EU/1/13/906/001 20140220
2213652	C300719	Netherlands		PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: EU/1/13/906 20140220
2213652	300719	Netherlands		PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: EU/1/13/906 20140224

Investment Scenario and Fundamentals Analysis for Florbetaben F-18

Last updated: February 22, 2026

What is Florbetaben F-18?

Florbetaben F-18 is a radioactive diagnostic agent approved for positron emission tomography (PET) imaging to detect amyloid-beta plaques in the brain. Approved by the FDA in 2014 (Under the trade name Neuraceq), it aids in the diagnosis of Alzheimer’s disease (AD) and other amyloid-related neurodegenerative disorders.

Market Overview and Growth Drivers

Market Size and Segmentation

• Global neuroimaging agents market reached approximately $1.8 billion in 2022.
• AD-specific diagnostic agents account for 40% of neuroimaging market revenue.
• PET imaging agents like florbetaben F-18 hold a dominant position within AD diagnostics, driven by increasing early diagnosis demand.

Drivers

• Aging Population: The global population aged 65+ is projected to double by 2050, reaching over 1 billion (United Nations, 2019).
• Rising Prevalence of AD: Estimated to reach 152 million cases worldwide by 2050 (Prince et al., 2015).
• Preference for Early and Accurate Diagnosis: PET tracers like florbetaben F-18 improve diagnostic accuracy, influencing market adoption.

Competitive Landscape

Company	Product Name	Approval Year	Market Share	Key Competitors
PET Imaging (Roche)	Neuraceq	2014	~50%	Amyvid (Lilly), Vizamyl (GE)
Lilly	Amyvid	2012	~30%	Neuraceq, Vizamyl
GE Healthcare	Vizamyl	2013	~20%	Amyvid, Neuraceq

Key Market Players

• Roche (NEURACEQ): First FDA-approved agent for amyloid imaging.
• Eisai/Lilly (Amyvid): Competitor with broad US market penetration.
• GE Healthcare (Vizamyl): Offers competitive alternative, primarily in select regions.

Regulatory and Reimbursement Environment

Regulatory Status

• FDA approval granted in 2014.
• EMA approval granted in 2014.
• Japan approved in 2015.

Reimbursement Policies

• Covered by Medicare in the U.S. since 2015.
• Reimbursement codes enable physician and hospital coverage, facilitating market expansion.

Scientific and Clinical Fundamentals

Mechanism of Action

• Florbetaben F-18 binds selectively to amyloid-beta plaques.
• Visualized via PET imaging, providing a non-invasive assessment of amyloid burden.

Diagnostic Performance

• Sensitivity: ~90%
• Specificity: ~80%
• Compared to CSF analysis, PET imaging yields higher specificity but higher costs.

Investment Considerations

Advantages

• Accelerated adoption in neurology clinics.
• Increasing demand in clinical trials for AD therapeutics.
• Potential label expansion to include other neurodegenerative conditions.

Risks

• Market competition from other tracers, including the upcoming radiotracers with longer half-lives.
• Regulatory delays or restrictions impacting usage.
• Reimbursement challenges in emerging markets.

Development Pipeline

• Multiple companies exploring next-generation amyloid tracers with improved binding specificity.
• Some agents under review or in late-stage clinical trials, which may impact florbetaben F-18's market share.

Financial Outlook

• Revenue projections for florbetaben F-18 vary; global sales could reach $200-$300 million by 2027, driven by diagnostic expansion.
• Production costs are relatively stable, with radioactive half-life (~110 minutes) limiting logistics and distribution.

Conclusions: Investment Viability

Florbetaben F-18 operates within a growingly important segment driven by demographic shifts and diagnostic needs. Its established regulatory status and reimbursement make it a relatively stable asset. Market competition and technological advances pose risks but also opportunities for value growth through expansion and label enhancements.

Key Takeaways

• The global AD diagnostic market is expanding rapidly, with florbetaben F-18 positioned as a key imaging agent.
• Its clinical utility and reimbursement support steady demand, but competition from newer tracers and market saturation pose challenges.
• Forecasts suggest moderate revenue growth, with the sector likely to see increased clinical and investment interest.

Frequently Asked Questions

1. Is florbetaben F-18 approved outside the U.S.?
Yes, it has EMA approval (Europe) and approval in several Asian countries, promoting regional growth.

2. What are the main competitors to florbetaben F-18?
Amyvid (Lilly), Vizamyl (GE Healthcare), and emerging tracers with longer half-lives or different binding profiles.

3. How does reimbursement influence market adoption?
Reimbursement codes under Medicare and private insurers facilitate hospital and provider use, accelerating adoption.

4. What are the prospects for label expansion?
Clinical trials exploring application to other neurodegenerative diseases could extend label indications, boosting revenues.

5. How do logistical factors impact distribution?
Short half-life (~110 minutes) limits shipping to local markets, increasing logistics complexity and costs.

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References

[1] United Nations. (2019). World Population Ageing 2019.
[2] Prince, M., et al. (2015). The Global Prevalence of Dementia. Alzheimer's & Dementia, 11(6), 631-648.
[3] FDA. (2014). Neuraceq FDA Approval Letter.
[4] MarketsandMarkets. (2022). Neuroimaging Agents Market.
[5] ClinicalTrials.gov. (2022). Various AD-related imaging studies.