florbetapir f-18 - Profile

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

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

Florbetapir f-18 has fifty-one patent family members in thirty-three countries.

Summary for florbetapir f-18

International Patents:	51
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for florbetapir f-18

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

Constraining patent/regulatory exclusivity:

7,687,052

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 florbetapir f-18

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-001	Apr 6, 2012		DISCN	Yes	No	7,687,052		Y	Y
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-001	Apr 6, 2012		DISCN	Yes	No	8,506,929		Y	Y
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-004	Oct 13, 2023		RX	Yes	Yes	8,506,929		Y	Y
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-004	Oct 13, 2023		RX	Yes	Yes	7,687,052		Y	Y
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-002	Apr 6, 2012		DISCN	Yes	No	7,687,052		Y	Y
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-002	Apr 6, 2012		DISCN	Yes	No	8,506,929		Y	Y

International Patents for florbetapir f-18

Country	Patent Number	Title	Estimated Expiration
Slovenia	1999109
Ukraine	97802
Luxembourg	92232
New Zealand	570887
Eurasian Patent Organization	017898
Guatemala	200800201

Supplementary Protection Certificates for florbetapir f-18

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1999109	C20130016 00076	Estonia		PRODUCT NAME: FLORBETAPIIR (18F);REG NO/DATE: K(2013)137 (LOPLIK) 14.01.2013
1999109	2013C/044	Belgium		PRODUCT NAME: AMYVID - FLORBETAPIR (18F); AUTHORISATION NUMBER AND DATE: EU/1/12/805 20130114
1999109	122013000051	Germany		PRODUCT NAME: FLORBETAPIR (18F); REGISTRATION NO/DATE: EU/1/12/805 20130114
1999109	C300600	Netherlands		PRODUCT NAME: FLORBETAPIR ( SUP 18 /SUP F); REGISTRATION NO/DATE: EU/1/12/805 20130114
1999109	139 5017-2013	Slovakia		PRODUCT NAME: FLORBETAPIR ( 18 F); REGISTRATION NO/DATE: EU/1/12/805 20130114
1999109	C01999109/01	Switzerland		PRODUCT NAME: FLORBETAPIR (18F); REGISTRATION NO/DATE: SWISSMEDIC 62897 09.01.2014

Florbetapir F-18: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

Florbetapir F-18 (commercially known as Amyvid) is a diagnostic PET imaging agent approved by the FDA in 2012 for detecting amyloid plaques in the brain related to Alzheimer's disease (AD). It represents a significant segment of neuroimaging diagnostics, providing a non-invasive method to aid in AD diagnosis.

The pharmaceutical investment landscape for Florbetapir F-18 is influenced by increasing global AD prevalence, evolving regulatory policies, technological advancements in PET imaging, and competitive dynamics within diagnostic radiopharmaceuticals. Market growth is driven by rising awareness, reimbursement policies, and innovations in radiotracer development.

This report evaluates the current and projected market size, competitive environment, regulatory influences, and financial outlook, guiding stakeholders on the investment viability of Florbetapir F-18.

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1. Investment Scenario Overview

1.1 Market Size and Growth Potential

Parameter	Value / Projection	Source / Notes
2022 Global AD Diagnoses	~55 million cases	Alzheimer's Association [1]
Projected AD cases (2030)	~78 million	Global estimates, CAGR 3.2%
PET Amyloid Imaging Market (2022)	$350 million	MarketsandMarkets [2]
Expected CAGR (2022-2030)	9.0-11.0%	Based on industry reports

Florbetapir F-18 is a key agent within the PET amyloid imaging market, which is expected to grow substantially driven by increased clinical use.

1.2 Revenue Drivers

• Increased prevalence of AD: Aging populations in North America, Europe, and Asia.
• Regulatory approvals: Expansion into international markets such as the EU, Asia.
• Reimbursement policies: Payer acceptance influences clinician adoption.
• Technological improvements: Precision in imaging, reduced scan times.

1.3 Investment Risks

Risk Factor	Impact	Mitigation
Market competition	Potential loss of market share	Strategic partnerships, portfolio diversification
Regulatory changes	Delays or restrictions	Proactive regulatory engagement
Technological obsolescence	Reduced demand	R&D investment in next-gen tracers
Reimbursement policies	Price erosion	Advocating for favorable coverage policies

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2. Market Dynamics

2.1 Competitive Landscape

Competitors	Main Products	Market Position	Notes
Avid Radiopharmaceuticals (by Lilly)	Amyvid (Florbetapir F-18)	Market leader	First FDA-approved amyloid PET agent
GE Healthcare	Flutemetamol (Vizamyl)	Competitor	Approved in several markets
Siemens	Amyloid PET tracers	Emerging	Invests in amyloid imaging advances
Pharmads	Novel tracers	Early-stage	Potential future competitors

2.2 Regulatory Environment

• FDA (USA): Approved in 2012; ongoing labeling updates.
• EMA (Europe): Approved as a CE-marked product.
• Japan, China: Regulatory approval processes underway, expanding market potential.

2.3 Market Penetration & Adoption Rates

Region	Adoption Rate (2022)	Projected (2025)	Factors influencing uptake
North America	65%	75%	High awareness, reimbursement
Europe	50%	62%	Reimbursement codes improving
Asia-Pacific	20%	40%	Growing infrastructure, clinical awareness

2.4 Pricing & Reimbursement

Pricing Model	Approximate Cost per Scan	Notes
USA	$3,000 – $4,000	Varies by provider, insurance coverage
Europe	€2,500 – €3,500	Reimbursement policies evolving
Asia	$2,000 – $2,800	Emerging payer policies

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3. Financial Trajectory

3.1 Revenue Projections (2022-2030)

Year	Estimated Revenue (USD millions)	CAGR	Notes
2022	350	—	Baseline (current market size)
2025	510	11.0%	Increased adoption, expanded markets
2028	740	11.0%	Market maturation, new territories
2030	950	10.8%	Market saturation trends

3.2 Cost Structure and Profitability

Cost Component	Approximate % of Revenue	Notes
R&D	10-12%	Continuous development of new tracers
Manufacturing	8-10%	GMP compliance, scale economies
Regulatory & Marketing	12-15%	Market expansion, education campaigns
Overheads	15-20%	Administrative, logistics

3.3 Investment Return Metrics

Metric	Estimate	Notes
Break-even Point	Year 3-4	Based on current revenue trajectories
ROI (2022-2030)	15-20%	Given market expansion and product lifecycle
Valuation Multiples	EV/EBITDA: 12-15x	Typical for pharmaceutical imaging agents

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4. Comparative Analysis with Emerging Diagnostic Imaging Agents

Parameter	Florbetapir F-18	Flutemetamol	Amyloid PET tracers (general)
FDA Approved	Yes	Yes	Varies
Market Penetration	High	Moderate	Emerging
Cost per Scan	$3,000 – $4,000	~$3,000	Similar or variable
Competitive Edge	First FDA approval	Longer market presence	Innovation potential

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5. Market Entry Strategies & Policy Considerations

Strategy	Key Points	Implementation Examples
Regulatory Expansion	Rapid approval in emerging markets	Collaborate with local authorities
Reimbursement Advocacy	Demonstrate clinical utility	Engage with CMS, NICE, local payers
Pipeline Diversification	Develop PET tracers for other neurodegenerative biomarkers	Invest in R&D
Partnerships	Co-marketing with hospitals & imaging centers	Alliances with radiology groups

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6. Comparative Analysis & Industry Outlook

• Market Growth: Estimated CAGR 9-11% through 2030, driven by aging populations and increased diagnostic awareness.
• Competitive Position: As the pioneer, Lilly’s Amyvid maintains a dominant position, but newer agents and technological innovations threaten market share.
• Pricing Strategies: Variability across regions necessitates flexible pricing models, with reimbursement favorable in mature markets.
• Regulatory Landscape: Ongoing approvals in Asia signal growing adoption opportunities.

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Key Takeaways

• Long-term growth prospects for Florbetapir F-18 hinge on increasing AD prevalence, technological pipeline advancements, and expanding global markets.
• Investment opportunities are robust in mature markets like North America and Europe, with promising expansion into Asia-Pacific.
• Competitive risks include emerging tracers, regulatory hurdles, and reimbursement challenges; strategic alliances and R&D investment mitigate these.
• Revenue projections suggest a compound annual growth rate of approximately 10-11% through 2030, with a strong financial trajectory.
• Market positioning as a first-to-market diagnostic agent provides a strategic advantage, though continuous innovation and marketing are essential.

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FAQs

Q1: What are the primary drivers for market growth in Florbetapir F-18?
A1: Increasing global AD prevalence, regulatory approvals expanding market access, reimbursement policy improvements, and technological advancements in PET imaging.

Q2: How does Florbetapir F-18 compare financially to its competitors?
A2: It benefits from being the first FDA-approved agent, commanding premium pricing and higher market penetration, though newer competitors are leveraging advanced imaging techniques and targeted diagnostics.

Q3: What are the regulatory challenges facing Florbetapir F-18?
A3: Regulatory approvals vary by region; ongoing efforts are required to obtain approvals in emerging markets and adapt labeling based on evolving clinical evidence.

Q4: What is the outlook for reimbursement policies for amyloid PET imaging?
A4: Reimbursement is improving in established markets, driven by clinical utility evidence. Policy developments in Asia and other regions are ongoing, influencing adoption.

Q5: What are the key strategic moves investors should monitor?
A5: Expansion into new markets, pipeline development for next-generation tracers, partnerships with pharma and diagnostic centers, and regulatory milestones.

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References

[1] Alzheimer's Association. 2022 Alzheimer's Disease Facts and Figures. Alzheimer’s & Dementia. 2022.
[2] MarketsandMarkets. PET Imaging Market by Application, Product, and Region — Global Forecast to 2030. 2022.