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 is one patent protecting this drug.

This drug has twenty-three patent family members in twenty 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:	23
US Patents:	1
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

Constraining patent/regulatory exclusivity:

8,916,131

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 one US patents.

This potential generic entry date is based on patent 8,916,131.

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	8,916,131		Y
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013		RX	Yes	Yes	8,916,131		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	203137-001	Oct 25, 2013	7,270,800
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013	7,351,401
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013	8,691,185
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013	7,351,401
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013	7,270,800
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013	8,691,185
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-001	Oct 25, 2013	8,236,282

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
Hungary	1500560	Thioflavin derivatives and their use in diagnosis and treatment of alzheimer's disease
Norway	20054674
Japan	2004506723
Spain	2464715
Hong Kong	1058041	THIOFLAVIN DERIVATIVES AND THEIR USE IN DIAGNOSIS AND THERAPY OF ALZHEIMER'S DISEASE
Portugal	1334091
Poland	215711

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	122015000016	Germany		PRODUCT NAME: FLUTEMETAMOL (18F) ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ, HYDRAT ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/14/941 20140822
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
1611115	2015C/005	Belgium		PRODUCT NAME: FLUTEMETAMOL (18F); AUTHORISATION NUMBER AND DATE: EU/1/14/941 20140826
1611115	2015/004	Ireland		PRODUCT NAME: VIZAMYL-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: A Comprehensive Analysis

Last updated: January 14, 2026

Summary

VIZAMYL (florbetapir F-18 injection) is a diagnostic imaging agent approved by the U.S. Food and Drug Administration (FDA) in 2012 for PET imaging to estimate beta-amyloid plaque density in adult patients with cognitive impairment. As the only FDA-approved tracer for beta-amyloid detection, VIZAMYL holds a pivotal role in the Alzheimer’s disease (AD) diagnostic landscape. This analysis evaluates current market dynamics, financial outlook, competitive positioning, and future drivers influencing VIZAMYL’s trajectory through 2030.

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What is the Current Market Landscape for VIZAMYL?

Market Overview

Aspect	Details
Approval Date	2012 (FDA)
Indications	PET imaging for beta-amyloid plaques in Alzheimer's diagnosis
Global Presence	Primarily North America, expanding in Europe and select markets
Market Size (2022)	Estimated US$ 150 million; global approx. US$ 210 million
Leading Competitor	Amyvid (Florbetapir), developed by Avid Radiopharmaceuticals (Roche)
Market Penetration	Moderate; limited by high costs, infrastructure, and regulatory barriers

Market Drivers

• Rising Prevalence of Alzheimer’s Disease
  Global incidence of AD is projected to reach 152 million by 2050, swelling demand for diagnostic tools (WHO, 2021).

• Regulatory Approvals & Favorable Policies
  Continued FDA renewals and European CE marking bolster market confidence.

• Advances in PET Imaging Technology
  Enhanced image quality and reduced scan times improve clinical utility.

Market Barriers

• High Cost of PET Imaging and Tracers
  A single scan costs approximately US$ 3,000–5,000, limiting accessibility.

• Limited Reimbursement
  Coverage by insurers varies; reimbursement policies significantly impact sales.

• Availability Constraints
  Short half-life (~110 mins), requiring nearby cyclotrons and logistics.

• Competition from Alternative Diagnostics
  Emerging blood-based biomarkers threaten traditional imaging modalities.

Regulatory & Policy Impact

• FDA and EMA Endorsements
  Support market growth with approvals and guideline integrations.

• Reimbursement Policies
  Centers for Medicare & Medicaid Services (CMS) covers VIZAMYL under specific conditions; reimbursement rates influence utilization.

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Financial Trajectory and Forecast for VIZAMYL

Historical Revenue Trends

Year	Revenue (USD millions)	Notes
2012	$0.5	Initial launch, limited adoption
2015	$25	Increased awareness; expanded centers
2018	$70	Growing adoption, reimbursement uptick
2022	~$150	Broadening clinical use, regional expansion

Data sourced from company disclosures and industry reports.

Projected Revenue Growth (2023-2030)

Year	Estimated Revenue (USD millions)	CAGR	Assumptions
2023	$165	10%	Continued adoption, new clinical guidelines
2025	$210	12%	Increased penetration in Europe/Asia, policy boosts
2030	$330	13%	Greater adoption, competitive landscape stabilization

Key Financial Drivers

• Expansion into Europe and Asia
  Anticipated approval and reimbursement policies in China, Japan, and EU nations.

• Introduction of Next-Generation Tracers
  Potential "second-generation" agents with longer half-lives and lower costs.

• Increasing Use in Clinical Trials
  Growing number of AD trials elevates demand for diagnostic agents.

• Partnerships & Collaborations
  Strategic alliances with hospitals, imaging centers, and biotech partners will amplify outreach.

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Comparative Landscape: VIZAMYL vs. Competitors

Attribute	VIZAMYL	Amyvid (Florbetapir)	LUMITAZ (Tau Imaging)
Approval Year	2012	2012	2021 (Tau tracers)
Half-life	110 mins	110 mins	80 mins
Indications	Beta-amyloid PET	Beta-amyloid PET	Tau pathology detection
Pricing (per dose)	~$350	~$425	N/A (early-stage)
Reimbursement Status	Favorable in US	Similar	Pending approval
Market Share (2022)	~45%	~50%	Emerging

Note: VIZAMYL holds a robust patent portfolio, providing some exclusivity.

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Future Market Drivers Impacting VIZAMYL

Technological Innovations

• Next-Generation Imaging Agents
  Longer half-life tracers (e.g., F18-based agents like VIZAMYL) could replace shorter-life isotopes, facilitating wider distribution.

• Artificial Intelligence (AI) Integration
  AI algorithms improving image analysis could increase diagnostic accuracy, expanding use cases.

• Blood-Based Biomarkers as First Line
  While less invasive, these are unlikely to fully replace PET imaging soon but may impact volume growth.

Regulatory & Policy Developments

• Expanded Reimbursement & Coverage
  Policies that broaden Medicare/Medicaid and private insurer coverage enhance market potential.

• Global Expansion
  Rapid approval in emerging markets presents significant volume upside.

Clinical & Academic Adoption

• Increasing adoption in early diagnosis and monitoring, especially with evolving diagnostic guidelines.

• Genetics and biomarker integration to refine patient stratification.

Competitive Pressures

• Entry of new imaging agents with longer shelf lives and lower costs.

• Development of non-invasive alternatives may threaten market share.

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Market Risks and Opportunities

Risks	Opportunities
Policy shifts reducing reimbursement	Expansion into underpenetrated markets
Development of more durable tracers	Integration with AI diagnostics
Price wars among competitors	Growing global AD burden, increasing demand

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Conclusion: Strategic Outlook for VIZAMYL

VIZAMYL is positioned as a critical diagnostic tool in the AD landscape, with a steady growth trajectory driven by escalating disease prevalence, technological advances, and evolving regulatory landscapes. Its financial performance should continue its upward trajectory, assuming sustained clinical adoption and favorable policy environments. Strategic initiatives focusing on international expansion, technological innovation, and strengthening reimbursement pathways will be vital to maintaining and growing market dominance.

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Key Takeaways

• VIZAMYL’s market revenue is expected to grow at a compounded rate of approximately 12-13% annually through 2030, reaching ~$330 million globally.
• The drug benefits from its FDA approval, established clinical utility, and a comparatively favorable reimbursement environment in the U.S.
• Competition from alternative agents and emerging blood-based diagnostics may challenge market share but also incentivize innovation.
• International expansion presents substantial growth potential, especially if regulatory and reimbursement barriers are reduced.
• Strategic partnerships and technological enhancements are critical to sustaining VIZAMYL’s market position.

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FAQs

Q1: How does VIZAMYL compare to other beta-amyloid tracers in terms of approval timeline?
A: VIZAMYL received FDA approval in 2012, simultaneously with Amyvid. Its longer half-life (110 mins) offers logistical advantages over PET tracers with shorter half-lives, like those using Carbon-11.

Q2: What are the main factors influencing VIZAMYL’s reimbursement status?
A: Reimbursement is primarily influenced by demonstrated clinical utility, integration into diagnostic guidelines, cost-effectiveness analyses, and payer policies. CMS and private insurers currently provide coverage under certain conditions.

Q3: How might emerging blood-based biomarkers impact VIZAMYL’s future?
A: Blood-based biomarkers could reduce reliance on PET imaging for screening, potentially limiting volume growth but likely complementing rather than replacing imaging for confirmation and staging.

Q4: What regions beyond North America hold significant growth potential?
A: Europe, China, Japan, and other APAC countries represent significant markets due to rising AD prevalence and improving healthcare infrastructure.

Q5: What are the main technological innovations poised to influence the market?
A: Development of longer half-life tracers, AI-driven image analysis, and combined diagnostic approaches incorporating genetics and fluid biomarkers.

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References

1. World Health Organization. (2021). Dementia Fact Sheet.
2. FDA. (2012). FDA Approves First PET Scan for Alzheimer’s Disease.
3. Industry Reports. (2022). Global Alzheimer’s Disease Diagnostic Market.
4. CMS. (2022). Medicare Coverage of PET Imaging Agents.
5. Avid Radiopharmaceuticals. (2012). Amyvid Product Details.