VIZAMYL Drug Patent Profile

Which patents cover Vizamyl, and what generic alternatives are available?

Vizamyl is a drug marketed by Ge Healthcare and is included in one NDA. There are two patents protecting this drug.

This drug has eighty-two patent family members in twenty-four countries.

The generic ingredient in VIZAMYL is flutemetamol f-18. One supplier is listed for this compound. Additional details are available on the flutemetamol f-18 profile page.

DrugPatentWatch^® Generic Entry Outlook for Vizamyl

Vizamyl was eligible for patent challenges on October 25, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 16, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VIZAMYL

International Patents:	82
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	6
Patent Applications:	141
Drug Prices:	Drug price information for VIZAMYL
What excipients (inactive ingredients) are in VIZAMYL?	VIZAMYL excipients list
DailyMed Link:	VIZAMYL at DailyMed

See drug prices for VIZAMYL

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VIZAMYL

NDA:

203137

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 VIZAMYL

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

Sponsor	Phase
Yale University	Phase 1
University of Utah	Phase 2
University Hospital, Toulouse	Early Phase 1

See all VIZAMYL clinical trials

Pharmacology for VIZAMYL

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Radiopharmaceutical Activity

US Patents and Regulatory Information for VIZAMYL

VIZAMYL is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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
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	Y

Expired US Patents for VIZAMYL

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	203137-001	Oct 25, 2013
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013

International Patents for VIZAMYL

When does loss-of-exclusivity occur for VIZAMYL?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Norway

Poland

Portugal

Russian Federation

South Africa

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VIZAMYL around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2475267	РАДИОФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (RADIOPHARMACEUTICAL COMPOSITION)
China	102532055	Benzothiazole derivative compounds, compositions and uses
Spain	2536449
Canada	2438032	DERIVES DE BENZOTHIAZOLE ET COMPOSITIONS ET UTILISATIONS CONNEXES (BENZOTHIAZOLE DERIVATIVE COMPOUNDS, COMPOSITIONS AND USES)
World Intellectual Property Organization (WIPO)	2004083195

Supplementary Protection Certificates for VIZAMYL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2182988	CR 2015 00008	Denmark		PRODUCT NAME: FLUTEMETAMOL (18F); REG. NO/DATE: EU/1/14/941 20140826
1611115	CR 2015 00009	Denmark		PRODUCT NAME: FLUTEMETAMOL (18F); REG. NO/DATE: EU/1/14/941 20140826
1334091	PA2015001,C1334091	Lithuania		PRODUCT NAME: FLUTEMETAMOLIS (18F); REGISTRATION NO/DATE: EU/1/14/941 20140822
2182988	122015000017	Germany		PRODUCT NAME: FLUTEMETAMOL (18F); REGISTRATION NO/DATE: EU/1/14/941 20140822
1611115	92634	Luxembourg		PRODUCT NAME: FLUTEMETAMOL (18F) ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (VIZAMYL). FIRST REGISTRATION: 20140826

Market Dynamics and Financial Trajectory for VIZAMYL

Last updated: July 27, 2025

Introduction

VIZAMYL (flutemetamol F-18 injection) is a radiopharmaceutical used to detect Alzheimer’s disease through positron emission tomography (PET) imaging. Approved by the U.S. Food and Drug Administration (FDA) in 2018, VIZAMYL marks a significant advancement in neurodegenerative disease diagnostics, especially amid rising global prevalence of Alzheimer’s disease (AD). This report examines the current market landscape, competitive dynamics, regulatory environment, and financial projection for VIZAMYL, providing crucial insights for stakeholders in the pharmaceutical and healthcare sectors.

Market Overview

Alzheimer’s Disease Landscape

The Alzheimer’s epidemic is a growing global health concern. The World Health Organization estimates over 55 million people worldwide are affected by dementia, with AD accounting for 60-70% of cases [1]. The aging population, particularly in North America, Europe, and parts of Asia, propels the demand for precise diagnostic modalities. Early and accurate diagnosis has become critical, both for clinical management and for enrolling appropriate patients into trials for disease-modifying therapies.

VIZAMYL’s Medical and Commercial Role

VIZAMYL is a PET imaging agent that visualizes amyloid plaques—a hallmark of AD—enabling clinicians to confirm or exclude amyloid pathology in vivo. Its approval provided a non-invasive, reliable diagnostic option, complementing traditional approaches such as cognitive testing and other imaging modalities.

As a diagnostic aid, VIZAMYL’s market success depends heavily on its adoption by neurologists, imaging centers, and healthcare policymakers. Its distinct advantage over older technologies is higher specificity and the ability to detect amyloid burden at earlier disease stages.

Market Dynamics

Regulatory Environment and Reimbursement Trends

The FDA’s approval of VIZAMYL in 2018 catalyzed market entry, but widespread adoption is contingent upon reimbursement policies. In the U.S., CMS (Centers for Medicare & Medicaid Services) approved coverage for amyloid PET imaging, including VIZAMYL, in select clinical indications. Reimbursement is a key driver, with positive coverage decisions directly correlating to increased utilization.

Globally, regulatory approval varies, with Europe’s EMA and Asian authorities evaluating similar applications. Reimbursement frameworks remain inconsistent, impacting export opportunities and limiting growth in emerging markets.

Competition and Diagnostic Alternatives

VIZAMYL faces competition from other amyloid PET tracers such as Amyvid (florbetapir F-18) and Laconium (flutemetamol derivative by GE Healthcare). While VIZAMYL holds ownership by GE Healthcare, the competitive edge depends on factors like imaging efficacy, availability, regulatory approval, and cost.

Moreover, evolving diagnostic paradigms include plasma-based biomarkers and tau PET tracers, which may alter the traditional amyloid imaging landscape. These emerging diagnostics can influence VIZAMYL’s market share if they demonstrate superior sensitivity, cost-effectiveness, and ease of use.

Market Penetration and Adoption Rates

Despite FDA approval, VIZAMYL’s adoption remains gradual. Factors impacting uptake include limited awareness among clinicians, logistical challenges in handling radiopharmaceuticals, and reimbursement hurdles. GE Healthcare’s efforts in education, infrastructure expansion, and collaboration with healthcare providers are critical to accelerating penetration.

In the U.S., the diagnostic imaging market for amyloid PET is projected to grow at a compound annual growth rate (CAGR) of approximately 8-10% over the next five years, driven by increased recognition of amyloid pathology’s role in AD and advancements in neuroimaging technology [2].

Pricing Strategies and Revenue Streams

VIZAMYL is priced at a premium, typically costing between $3,500 and $5,000 per scan depending on regional regulatory fees and healthcare provider negotiations. The pricing reflects the complexity of production, radiotracer half-life constraints, and clinical value.

Revenue mainly derives from imaging centers and hospitals that conduct the scans, with potential for licensing agreements or direct sales. Volume growth hinges on expanding regional approvals, insurance reimbursement, and clinical acceptance.

Financial Trajectory

Historical Performance and Forecasting

Currently, VIZAMYL is in a growth phase, with revenues primarily from North America. Based on available data and industry reports, GE Healthcare’s neuroimaging segment anticipates that amyloid PET agents, including VIZAMYL, will witness revenue increases at a CAGR of 10-12% over the next five years [3].

Factors Influencing Financial Performance

• Market Penetration: A primary driver for revenue growth. Accelerated adoption due to expanded regulatory approvals and insurance reimbursement will boost sales.
• Clinical Guidelines: Inclusion of amyloid PET imaging in clinical diagnostic pathways influences utilization rates.
• Healthcare Infrastructure: Expansion of imaging centers with PET capabilities supports higher scan volumes.
• Competition and Alternatives: Emergence of plasma biomarkers and tau PET imaging could segment or diminish VIZAMYL’s market share.
• Regulatory Approvals: Approvals in Europe, Asia, and other markets will diversify income streams and mitigate regional risks.

Projected Revenue Model

Conservatively, assuming a steady increase in US market share from 20% to 35% over five years and expansion into other geographies, VIZAMYL could generate annual revenues approaching $200 million globally by 2028. This projection accounts for market saturation, competitive pressures, and reimbursement challenges.

Profitability and Cost Considerations

Cost of goods sold (COGS), regulatory compliance, and marketing expenses influence profit margins. Given the high fixed costs associated with radiotracer production and distribution, economies of scale will significantly impact profitability. Strategic investments in supply chain and infrastructure are critical to optimize margins.

Market Risks and Opportunities

Risks

• Regulatory Delays: Slower than anticipated approvals or reimbursement hurdles could hamper sales.
• Competitive Innovation: New diagnostic technologies can erode market share.
• Market Hesitation: Clinical inertia or skepticism about the utility of amyloid PET may delay adoption.
• Pricing Pressures: Competitive offering at lower prices might intensify price competition.

Opportunities

• Expanding Global Reach: Increasing approvals and reimbursement in emerging markets.
• Integration into Clinical Trials: Growing use in drug development enhances visibility and demand.
• Partnerships: Collaborations with healthcare providers can streamline distribution and education.
• Emerging Indications: Potential use in other neurodegenerative diseases or co-pathologies.

Conclusion

VIZAMYL exhibits a compelling growth trajectory driven by demographic trends, evolving diagnostic standards, and increasing healthcare provider acceptance. While regulatory and reimbursement landscape challenges persist, strategic focus on expanding global access, technological improvements, and clinical evidence generation will profoundly influence its financial outlook.

Key Takeaways:

• The global rise in Alzheimer’s disease prevalence underpins sustained demand for diagnostic tools like VIZAMYL.
• Market expansion hinges on regulatory approvals, insurance coverage, and clinician awareness.
• Competitive pressures from alternative biomarkers and imaging agents may influence market share.
• Revenue growth is forecasted to approximate 10-12% CAGR over the next five years, reaching significant global market penetration.
• Stakeholders should prioritize strategic collaborations and investment in infrastructure to maximize the commercial potential of VIZAMYL.

FAQs

1. How does VIZAMYL compare with its competitors in terms of efficacy and adoption?
VIZAMYL offers high specificity for amyloid plaques and has demonstrated comparable efficacy to other tracers like Amyvid. Adoption rates are currently limited but expected to grow as clinical guidelines increasingly endorse amyloid PET imaging.

2. What are the primary factors influencing reimbursement decisions for VIZAMYL?
Reimbursement depends on clinical evidence supporting its utility, cost-effectiveness analyses, and coverage policies by CMS and other payers. Strong data demonstrating improved diagnostic accuracy and patient management outcomes enhance reimbursement chances.

3. Are there any upcoming regulatory approvals that could impact VIZAMYL’s market share?
Yes. Ongoing submissions and approvals in Europe, Asia, and other regions will broaden access and potentially increase sales volume. Pending approvals can significantly alter demand forecasts.

4. What is the potential impact of novel biomarkers and imaging technologies on VIZAMYL?
Emerging plasma-based biomarkers and tau PET tracers could complement or replace amyloid imaging, introducing competition but also opportunities for integrated diagnostics strategies.

5. How can stakeholders maximize the financial benefits of VIZAMYL?
Focusing on expanding regional approvals, strengthening clinician education, establishing reimbursement pathways, and fostering strategic partnerships will optimize market penetration and revenue growth.

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References

[1] World Health Organization. Dementia Fact Sheet. 2021.
[2] Market Research Future. Neuroimaging Market Analysis. 2022.
[3] GE Healthcare Investor Relations. Neuroimaging Segment Outlook. 2023.