Flutemetamol f-18 - Generic Drug Details

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

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

Flutemetamol f-18 has eighty-two patent family members in twenty-four countries.

One supplier is listed for this compound.

Summary for flutemetamol f-18

International Patents:	82
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	20
What excipients (inactive ingredients) are in flutemetamol f-18?	flutemetamol f-18 excipients list
DailyMed Link:	flutemetamol f-18 at DailyMed

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

Dosage:

INJECTABLE;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 flutemetamol f-18

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

Sponsor	Phase
Akiva Mintz	PHASE2
Yale University	Phase 1
Shanghai Mental Health Center	Phase 4

See all flutemetamol f-18 clinical trials

Pharmacology for flutemetamol f-18

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

US Patents and Regulatory Information for flutemetamol f-18

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013		DISCN	Yes	No			Y	Y
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013		RX	Yes	Yes			Y	Y
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013		DISCN	Yes	No			Y
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013		RX	Yes	Yes			Y

Expired US Patents for flutemetamol f-18

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013

International Patents for flutemetamol f-18

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0113470	composto de ligação amilóide, composição farmacêutica e métodos de síntese de composto, de detecção in vivo de depósitos amilóides num indivíduo e em tecido humano ou animal, de quantificação de depósito amilóide em tecido de biópsia ou postmortem e de distinção de um cérebro de doença de alzheimer de um cérebro normal
Norway	20030860
Portugal	2264018
China	1784392	Benzothiazole derivative compounds,compositions and uses
Australia	8670201	Thioflavin derivatives for use in antemortem diagnosis of alzheimer's disease and in vivo imaging and prevention of amyloid deposition
South Korea	101571572
Japan	2012102106	THIOFLAVIN DERIVATE FOR USE IN THE ANTEMORTEM DIAGNOSIS OF ALZHEIMER'S DISEASE AND IN VIVO IMAGING AND PREVENTION OF AMYLOID DEPOSITION

Supplementary Protection Certificates for flutemetamol f-18

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1611115	2015/004	Ireland		PRODUCT NAME: VIZAMYL-FLUTEMETAMOL (18F); REGISTRATION NO/DATE: EU/1/14/941 20140822
2182988	6/2015	Austria		PRODUCT NAME: (18F) - FLUTEMETAMOL; REGISTRATION NO/DATE: EU/1/14/941 (MITTEILUNG) 20140826
2182988	573	Finland
1611115	1590010-3	Sweden		PRODUCT NAME: FLUTEMETAMOL (18F); REG. NO/DATE: EU/1/14/941 20140826
2182988	SPC/GB15/012	United Kingdom		PRODUCT NAME: FLUTEMETAMOL (18F) OR A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF; REGISTERED: UK EU/1/14/941 20140826
1334091	PA2015001	Lithuania		PRODUCT NAME: FLUTEMETAMOLUM (18F); REGISTRATION NO/DATE: EU/1/14/941 20140822
1611115	CA 2015 00009	Denmark		PRODUCT NAME: FLUTEMETAMOL (18F); REG. NO/DATE: EU/1/14/941 20140822

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: FLUTEMETAMOL F-18

Last updated: July 29, 2025

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Introduction

The pharmaceutical landscape is rapidly evolving, driven by innovations in diagnostic imaging and therapeutic agents. Flutemetamol F-18, a radiotracer used primarily in positron emission tomography (PET) imaging, exemplifies this shift. Its unique properties facilitate early and accurate detection of neurodegenerative diseases, notably Alzheimer’s disease. Understanding its market dynamics and financial trajectory involves examining technological advancements, regulatory pathways, competitive positioning, and global health trends.

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Overview of Flutemetamol F-18

Flutemetamol F-18 is a fluorine-18 labeled compound used as a PET radiotracer. Its primary application centers on amyloid plaque imaging in the brain, making it crucial in diagnosing Alzheimer’s disease and other amyloid-related neurodegenerative conditions. Given its role in improving diagnostic accuracy, it has garnered significant clinical and commercial interest.

The radiotracer’s synthesis involves complex radiochemistry, requiring specialized production facilities aligned with onsite or nearby cyclotron capabilities. As a diagnostic agent, Flutemetamol F-18 is typically administered in clinical settings, where it facilitates early diagnosis and treatment planning.

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Market Drivers

Growing Prevalence of Neurodegenerative Diseases

The global incidence of Alzheimer’s and other dementias is escalating, driven by aging populations. The World Health Organization reports over 55 million cases globally, with projections reaching nearly 78 million by 2030 (WHO, 2021). Early and accurate diagnosis, facilitated by PET imaging agents like Flutemetamol F-18, becomes imperative for effective intervention, thus expanding demand.

Advancements in PET Imaging Technologies

Improvements in PET scanner sensitivity, resolution, and image processing algorithms enhance the utility of Flutemetamol F-18. These technological advancements increase the tracer’s diagnostic accuracy, encouraging adoption among clinicians and healthcare institutions.

Regulatory Approvals & Reimbursement Policies

FDA approval of Flutemetamol F-18 signifies regulatory confidence, encouraging commercialization and uptake. Additionally, reimbursement policies that recognize PET imaging's clinical value influence institutional procurement decisions, further bolstering market growth.

Research and Clinical Trials

Ongoing clinical trials and research collaborations aim to expand Flutemetamol F-18’s applications beyond Alzheimer’s, including other neurodegenerative and psychiatric disorders. Positive outcomes reinforce market confidence and introduce potential revenue streams.

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Market Challenges and Barriers

Production Complexities and Costs

The synthesis of Fluorine-18 labeled radiotracers requires expensive cyclotron facilities and radiochemistry expertise, posing entry barriers for smaller institutions or developing regions. High costs impact pricing strategies and potential profit margins.

Short Half-life Constraints

Fluorine-18’s 110-minute half-life limits distribution to regions with nearby radiochemistry facilities, constraining market expansion into remote or underdeveloped markets.

Competition from Alternatives

Other amyloid-targeting PET tracers like Florbetapir (Amyvid) and Flutemetamol (Vizamyl) possess established clinical and regulatory pathways, intensifying competitive pressure. Differentiation based on cost, imaging efficacy, and regional availability becomes crucial.

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Financial Trajectory

Revenue Projections

The global PET radiotracer market is poised for steady growth, expected to reach approximately $1.5 billion by 2027, with Neurodegenerative agent segments capturing a significant share (Fortune Business Insights, 2022). Flutemetamol F-18, as a niche but increasing diagnostic agent, is projected to experience compound annual growth rates (CAGRs) of 7-10% over the next five years, predicated on increasing Alzheimer’s prevalence and improved diagnostic paradigms.

Pricing Strategies and Revenue Streams

Pricing varies based on regional healthcare policies and production costs. In North America, the price per dose can range from $1,000 to $2,500, including the radiotracer and associated imaging procedures. Pharmaceutical companies and imaging clinics that efficiently optimize supply chains and expand regional distribution can enhance profit margins.

Investment and Funding Dynamics

Global pharmaceutical companies are investing in radiotracer R&D, driven by the unmet need for neurodegenerative diagnostics. Venture capital and governmental grants support novel radiotracers, fostering competitive innovation. Licensing agreements and partnerships with imaging centers further augment revenue potential.

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Regional Market Insights

North America

North America dominates the market, owing to comprehensive healthcare infrastructure, high disease prevalence, and favorable reimbursement policies. The U.S. FDA’s approval process provides regulatory clarity, accelerating deployment.

Europe

Europe exhibits robust growth, supported by an aging population and expanding healthcare expenditure. Regulatory harmonization under the European Medicines Agency (EMA) simplifies approval pathways for radiotracers.

Asia-Pacific

Emerging markets like China and Japan present significant growth opportunities, driven by increasing healthcare access and research investments. However, infrastructural and regulatory development remains a hurdle.

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Future Outlook and Potential Market Expansion

The future of Flutemetamol F-18 hinges on broadening diagnostic indications, improving production scalability, and integrating advanced imaging analytics. Innovations such as hybrid PET/MRI systems can enhance image quality, fostering increased adoption.

Developments in automated synthesis modules promise cost reductions and expanded availability, especially in decentralized markets. Moreover, combining amyloid imaging with other biomarkers can facilitate personalized medicine approaches, opening avenues for combination diagnostics and therapeutics, thus enlarging revenue streams.

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Regulatory and Ethical Considerations

Navigating regulatory landscapes remains critical. Clearance pathways differ across jurisdictions, necessitating strategic planning for approvals, post-marketing surveillance, and compliance. Ethical considerations, such as patient safety and radiation exposure, influence clinical acceptance and reimbursement policies.

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Key Takeaways

• Growing Burden of Neurodegenerative Diseases drives demand for early diagnostic tools like Flutemetamol F-18.
• Regulatory approvals and reimbursement policies significantly influence market penetration and revenue potential.
• Production intricacies and logistics limit wider geographic reach, emphasizing the need for technological innovations in radiochemistry.
• Competitive landscape necessitates differentiation through cost, availability, and imaging efficacy.
• Market growth projections indicate a compound annual growth rate of approximately 7-10% over the next five years, reaching a significant share of the neuroimaging diagnostics market.

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FAQs

1. What factors influence the pricing of Flutemetamol F-18?
Pricing depends on production costs, regional healthcare policies, regulatory compliance, and the competitive landscape. High-cost cyclotron facilities and specialized radiochemistry skills also influence unit costs.

2. How does Flutemetamol F-18 compare to other amyloid PET tracers?
It benefits from regional approvals and distinct imaging properties but faces stiff competition from established agents like Florbetapir (Amyvid) and Flutemetamol (Vizamyl). Differentiation hinges on cost, availability, and clinical performance.

3. What are the main regulatory hurdles for expanding Flutemetamol F-18’s use?
Regulatory hurdles include securing approvals in new regions, demonstrating safety and efficacy, and navigating differing regional standards and reimbursement requirements.

4. How might technological innovations impact the market trajectory?
Advancements in automated synthesis, portable cyclotron technology, and hybrid PET/MRI imaging will improve accessibility, reduce costs, and expand clinical applications, positively impacting revenue.

5. What role do clinical trials play in driving the market?
Ongoing clinical research validates expanded indications, enhances clinician confidence, and fosters market expansion, directly affecting sales and adoption rates.

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References

1. World Health Organization. (2021). Dementia prevalence data.
2. Fortune Business Insights. (2022). PET Radiotracer Market Size, Share & Industry Analysis.
3. FDA. (2020). Regulatory approval announcements for amyloid PET tracers.