FLORBETAPIR F-18 - Generic Drug Details

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

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.

One supplier is listed for this compound.

Summary for FLORBETAPIR F-18

International Patents:	51
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	11
Clinical Trials:	50
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FLORBETAPIR F-18
DailyMed Link:	FLORBETAPIR F-18 at DailyMed

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.

Recent Clinical Trials for FLORBETAPIR F-18

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

Sponsor	Phase
Universidad de Antioquia	PHASE2
National Institute on Aging (NIA)	PHASE2
Banner Health	PHASE2

See all FLORBETAPIR F-18 clinical trials

Pharmacology for FLORBETAPIR F-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

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	202008-003	Apr 6, 2012		RX	Yes	Yes	8,506,929		Y	Y
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	202008-003	Apr 6, 2012		RX	Yes	Yes	7,687,052		Y	Y
Avid Radiopharms Inc	AMYVID	florbetapir f-18	SOLUTION;INTRAVENOUS	202008-004	Oct 13, 2023		RX	Yes	Yes	8,506,929		Y	Y

International Patents for FLORBETAPIR F-18

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007126733
Cyprus	2013024
Taiwan	200838852	Styrylpyridine derivatives and their use for binding and imaging amyloid plaques
Denmark	1999109

Supplementary Protection Certificates for FLORBETAPIR F-18

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1999109	481	Finland
1999109	SPC/GB13/040	United Kingdom		PRODUCT NAME: FLORBETAPIR (18F) ((E)-4-(2-(6-(2-(2-(2-((18F)-FLUOROETHOXY)ETHOXY)ETHOXY)PYRIDIN-3-YL(18F); REGISTERED: UK EU/1/12/805 20130117 )VINYL)-N-METHYL BENZENAMINE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY FLORBETAPIR
1999109	C01999109/01	Switzerland		PRODUCT NAME: FLORBETAPIR (18F); REGISTRATION NO/DATE: SWISSMEDIC 62897 09.01.2014
1999109	1390030-3	Sweden		PRODUCT NAME: FLORBETAPIR (18F); REG. NO/DATE: EU/1/12/805 20130114

Market Dynamics and Financial Trajectory for Florbetapir F-18

Last updated: July 29, 2025

Introduction

Florbetapir F-18, marketed under the brand name Amyvid, is a radiopharmaceutical agent developed to enable positron emission tomography (PET) imaging of amyloid plaques in the brain—a hallmark of Alzheimer's disease (AD). Approved by the U.S. Food and Drug Administration (FDA) in 2012, Florbetapir F-18 marked a significant advancement in neurodegenerative disease diagnostics, promising potential shifts in clinical management, drug development, and healthcare economics. This analysis explores the evolving market landscape and financial outlook of Florbetapir F-18, considering regulatory pathways, technological advancements, competitive dynamics, and broader healthcare trends.

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Market Fundamentals and Demand Drivers

The increasing prevalence of Alzheimer's disease globally propels demand for advanced diagnostic tools like Florbetapir F-18. Predicted to reach 131 million cases by 2050, as per Alzheimer's Disease International, the escalating burden necessitates accurate biomarker-based assessments (1). Currently, definitive diagnosis often occurs post-mortem; hence, in vivo detection of amyloid plaques offers substantial clinical value, potentially altering diagnostic algorithms and enabling early intervention strategies.

There is a burgeoning interest within the healthcare industry—clinicians, payers, and regulators—regarding the utility of amyloid imaging to refine diagnostic confidence. The insurance coverage landscape, presently variable across regions and payers, influences utilization rates. Medicare coverage expansion in the United States over recent years has significantly bolstered test adoption, setting a precedent for broader reimbursement policies (2).

Furthermore, parallel development of disease-modifying therapies (DMTs) targeting amyloid beta, such as Biogen's aducanumab, fuels demand for diagnostic imaging. Confirming amyloid presence pre-therapy enhances treatment selection accuracy, embedding Florbetapir F-18 within the therapeutic decision-making matrix.

Technological and Competitive Landscape

Florbetapir F-18's primary competitors include other amyloid PET tracers such as PiB (Pittsburgh compound B), flutemetamol (Vizamyl), and aforementioned DMTs that necessitate amyloid confirmation. The U.S. approval of fluorine-18 labeled tracers, benefiting from longer half-life (about 110 minutes) relative to carbon-11 compounds, optimizes logistics, broadens clinical reach, and reduces manufacturing complexity.

In recent years, the market has seen incremental innovation, with newer tracers like Amyloid PET for use in clinical practice targeting broader indications and gaining regulatory approvals in other regions such as the European Union and Japan. The competitive versatility of fluorine-18 tracers—due to established synthesis infrastructure—positions Florbetapir F-18 favorably, albeit with ongoing challenges regarding reimbursement policies and clinician adoption hurdles.

Regulatory and Clinical Adoption Factors

Regulatory approval remains pivotal; following FDA approval, other jurisdictions have implemented approvals or class options, while the ongoing development of real-world evidence bolsters their clinical utility claims. The recent approval of amyloid imaging agents as companion diagnostics for specific DMTs underscores their future relevance.

Clinical guidelines, such as those from the Alzheimer's Association and various neurology societies, increasingly integrate amyloid imaging, influencing practitioner adoption. However, variability in clinician familiarity, cost concerns, and logistical barriers continue to temper widespread usage.

Market Size and Financial Trajectory

The immediate market for Florbetapir F-18 hinges on PET imaging utilization rates in amyloid diagnostics. In the U.S., estimates suggest that approximately 100,000 to 150,000 amyloid PET scans were performed annually post-2015, coinciding with expanding insurance coverage and growing clinical confidence (3). The global market remains smaller but is poised for acceleration, especially with increases in dementia prevalence, improved reimbursement, and expanded use cases.

Revenue forecasts estimate that Florbetapir F-18 could generate between $200 million and $500 million annually in the United States within the next five years, contingent on the growth in diagnostic procedures. European and Asian markets, though smaller, present significant growth potential, driven by increasing healthcare investments and evolving diagnostic guidelines.

Manufacturing costs, including radiopharmaceutical synthesis, logistics, and quality assurance, impact profitability. The radiotracer's half-life benefits supply chain management, but the necessity of onsite cyclotrons or regional radiopharmacies influences distribution logistics and costs.

Impact of Amyloid PET Market Expansion

Growth prospects for Florbetapir F-18 will increasingly tie to the broader deployment of amyloid PET imaging in clinical practice and clinical trials. The expansion of Amyvid's indications to include assessment of amyloid pathology in cognitively impaired patients, and its potential future use as an enrichment biomarker in clinical trials, significantly influence revenue prospects.

Furthermore, regulatory agencies’ evolving frameworks and the inclusion of amyloid imaging in new diagnostic criteria will serve as catalysts. The U.S. FDA's recent approval of aducanumab and other DMTs underscores the strong linkage between diagnostic tools like Florbetapir F-18 and therapeutic pathways, enhancing their commercial relevance.

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Challenges and Risks

Despite promising prospects, challenges persist. Reimbursement variability remains a primary barrier, with payers scrutinizing the clinical utility and cost-effectiveness. The high cost of PET scans (~$3,000 per procedure) necessitates demonstrable value for scale adoption.

Moreover, controversies surrounding amyloid hypothesis debates, coupled with the asymptomatic nature of many amyloid accumulations, pose doubts on widespread screening benefits. Ethical questions about incidental findings and implications for patients with positive amyloid PET but no symptoms further complicate clinical decision-making.

Manufacturing and supply chain complexities, radiotracer shelf-life constraints, and ongoing competition from emerging imaging modalities (e.g., tau PET tracers, CSF testing) also shape future market dynamics.

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Regulatory and Policy Outlook

Regulatory agencies continue to refine frameworks for radiopharmaceutical approvals, emphasizing safety, efficacy, and clinical utility. The expansion of CMS (Centers for Medicare & Medicaid Services) coverage policies in the U.S. to encompass amyloid PET remains instrumental. International regulatory bodies are increasingly adopting harmonized standards, facilitating market entry in diverse territories.

Moreover, integration of Florbetapir F-18 within broader Alzheimer's disease diagnostic and therapeutic pathways will likely see increased policy support, particularly as early diagnostics become central to disease-modifying strategies.

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Conclusion

Florbetapir F-18’s market trajectory appears robust, driven by demographic trends, clinical necessity, and technological advancements. While hurdles such as reimbursement, clinical adoption hesitations, and competitive innovations exist, the agent’s established regulatory approval and logistical advantages position it favorably within the expanding landscape of neurodegenerative diagnostics.

The next decade will likely witness heightened utilization, with revenue growth tied to broader acceptance, reimbursement landscape shifts, and integration into therapeutic decision pathways. Companies investing in manufacturing capacity, clinician education, and evidence generation stand to benefit most from this emerging market.

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Key Takeaways

• Growing Demand: The rising prevalence of Alzheimer’s disease will continue to drive demand for Florbetapir F-18 as a critical diagnostic tool.
• Regulatory and Reimbursement Dynamics: Positive regulatory stances and expanding reimbursement policies, particularly in the U.S., underpin market growth.
• Competitive Edge: Fluorine-18 labeling offers logistical advantages over carbon-11 tracers, solidifying Florbetapir F-18’s market position.
• Market Potential: Estimated US revenue could reach up to $500 million annually within five years, with significant international expansion opportunities.
• Strategic Challenges: Reimbursement barriers, clinical adoption hurdles, and competition from emerging modalities necessitate strategic positioning.

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FAQs

1. What are the primary clinical applications of Florbetapir F-18?
   Florbetapir F-18 is primarily used for PET imaging to detect amyloid plaques in the brain, aiding in diagnosing Alzheimer’s disease and differentiating it from other dementias.

2. How does Florbetapir F-18 compare to other amyloid imaging agents?
   It benefits from fluorine-18’s longer half-life, facilitating wider distribution and logistical management compared to carbon-11 tracers like PiB, which require onsite cyclotrons.

3. What factors influence the market growth of Florbetapir F-18?
   Factors include increasing Alzheimer’s prevalence, regulatory approvals, reimbursement expansion, clinician awareness, and the integration of amyloid imaging into therapeutic pathways.

4. What are the main challenges facing Florbetapir F-18’s market expansion?
   Challenges include variable payer coverage, high procedure costs, clinician hesitation, and competition from other biomarkers and imaging modalities.

5. What is the future outlook for Florbetapir F-18 in Alzheimer’s diagnostics?
   The outlook is positive, with anticipated growth driven by expanding clinical applications, therapeutic developments requiring amyloid confirmation, and ongoing efforts to streamline reimbursement and clinical adoption.

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References

1. Alzheimer's Disease International. (2021). World Alzheimer Report 2021.
2. Medicare.gov. (2020). Coverage of Amyloid PET Imaging.
3. Fishman, P. S., & Jagust, W. J. (2015). Advances in Imaging and Data Interpretation in Alzheimer's Disease. Journal of Nuclear Medicine, 56(3), 359-364.