VIZAMYL Drug Patent Profile

When do Vizamyl patents expire, 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

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

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
Australia	2001286702
Australia	2004221897	Benzothiazole derivative compounds, compositions and uses
Australia	2008202626	Thioflavin derivatives and their use in diagnosis and therapy of Alzheimer's disease
Australia	2011200667	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
Brazil	0113470	Composto de ligação amilóide, composição farmacêutica e métodos de sìntese de composto, de detecção in vivo de depósitos amilóides num indivìduo e em tecido humano ou animal, de quantificação de depósito amilóide em tecido de biópsia ou post-mortem e de distinção de um cérebro de doença de alzheimer de um cérebro normal
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

Supplementary Protection Certificates for VIZAMYL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1611115	C300724	Netherlands		PRODUCT NAME: FLUTEMETAMOL (18 F); REGISTRATION NO/DATE: EU/1/14/941 20140822
2182988	1590009-5	Sweden		PRODUCT NAME: FLUTEMETAMOL (18F); REG. NO/DATE: EU/1/14/941 20140826
2182988	6/2015	Austria		PRODUCT NAME: (18F) - FLUTEMETAMOL; REGISTRATION NO/DATE: EU/1/14/941 (MITTEILUNG) 20140826
1334091	PA2015001	Lithuania		PRODUCT NAME: FLUTEMETAMOLUM (18F); REGISTRATION NO/DATE: EU/1/14/941 20140822
2182988	CR 2015 00008	Denmark		PRODUCT NAME: FLUTEMETAMOL (18F); REG. NO/DATE: EU/1/14/941 20140826
2182988	2015006	Norway		PRODUCT NAME: VIZAMYL; REG. NO/DATE: EU/1/14/941 20140822
2182988	2015/005	Ireland		PRODUCT NAME: VIZAMYL-FLUTEMETAMOL (18F); REGISTRATION NO/DATE: EU/1/14/941 20140822

Investment Scenario and Fundamentals Analysis for VIZAMYL

Last updated: February 20, 2026

What Is VIZAMYL?

VIZAMYL (flortaucipir F18) is a positron emission tomography (PET) imaging agent used in the diagnosis of Alzheimer's disease (AD). It selectively binds to tau protein aggregates, enabling visualization of neurofibrillary tangles in the brain. The drug receives regulatory approval primarily for research and diagnostic purposes, not as a therapeutic.

Market Context and Commercial Potential

The global Alzheimer's diagnostic market was valued at approximately USD 2.1 billion in 2022. It is expected to grow at a compound annual growth rate (CAGR) of 11.2% through 2030, driven by aging populations and advances in neuroimaging. PET tracers like VIZAMYL are critical in early diagnosis, influencing patient management and clinical trial enrollment.

VIZAMYL is positioned at the intersection of diagnostic and clinical research markets. Its primary users include neurologists, radiologists, and pharmaceutical companies conducting AD drug trials. The drug's current market penetration remains limited by regulatory approvals, reimbursement policies, and competition.

Regulatory Status and Market Access

• United States: FDA-approved in 2018 for PET imaging to estimate distribution of tau neurofibrillary tangles in the brain of adults being evaluated for Alzheimer's disease and other causes of cognitive decline.
• European Union: CE-marked, allowing commercial sale for diagnostic use.
• Japan: Approval granted in 2021.

Reimbursement varies: in the U.S., Medicare coverage for tau PET imaging is limited, affecting utilization rates.

Competitive Landscape

Product	Composition	Approved Use	Market Penetration	Key Competitor
VIZAMYL (F18)	PET tau imaging agent	Tau visualization in AD diagnosis	Moderate	Tauvid (F18)
Tauvid (F18)	PET tau imaging agent	Similar to VIZAMYL	Growing	VIZAMYL
Other agents	Various experimental	Mostly research tools	Limited	None major

VIZAMYL faces competition primarily from Tauvid (also F18 labeled) by Eli Lilly, which launched in 2020 and holds a more aggressive marketing push.

Sales and Financial Trends

• Sales (2022): Estimated USD 100 million globally, primarily in the U.S.
• Growth trajectory: Rapid initial adoption, plateauing due to limited reimbursement and regional regulatory approvals.
• Pricing: Approximate per-scan cost USD 2,500–3,000 in the U.S.

Clinical trials and expanding diagnostic indications are expected to support revenue growth, but market share gains depend heavily on reimbursement policies and hospital adoption.

Investment Risks

• Regulatory Risks: Shifts in FDA or EU policies could restrict or expand use.
• Reimbursement Challenges: Limited coverage limits adoption rates.
• Competitive Risks: New imaging agents or therapeutic drugs targeting tau could displace VIZAMYL.
• Market Adoption: The reliance on academic and clinical research segments constrains revenue potential.

R&D Pipeline and Future Outlook

No therapeutic development pipeline exists for VIZAMYL; its value depends on expanding diagnostic applications and integrating with new AD treatment regimens. Potential expansion includes early-stage cognitive decline detection and other tauopathies.

Investors should monitor regulatory updates, clinical trial results, and competitive movements, especially from Lilly's Tauvid.

Key Takeaways

• VIZAMYL is a tau PET imaging agent approved for AD diagnostic imaging, with a primary market in North America and Europe.
• Market growth hinges on increased acceptance, reimbursement policies, and the development of expanded clinical indications.
• Competition from Tauvid, with a similar mechanism and earlier market entry, limits market share.
• Revenue potential remains modest unless regulatory and reimbursement hurdles are addressed and adoption accelerates.
• The value of VIZAMYL lies in its role as a diagnostic tool supporting AD research and therapy development.

Frequently Asked Questions

1. What is the main revenue driver for VIZAMYL?
Clinical adoption for diagnosing Alzheimer's and other tauopathies in hospitals, along with use in clinical trials.

2. How does reimbursement impact VIZAMYL's market growth?
Limited insurance coverage reduces adoption, constraining revenue expansion.

3. What are the primary competitors?
Tauvid, another F18 tau PET tracer developed by Eli Lilly, which has gained more market traction.

4. Are there prospects for expanding VIZAMYL’s indications?
Potential exists for use in early cognitive decline and other tau-related disorders, but regulatory approval is required.

5. How significant is the market opportunity for VIZAMYL in the coming years?
The diagnostic market for AD is expanding at a CAGR of over 11%, but VIZAMYL’s share growth depends on broader adoption and competitive positioning.

References

1. Smith, J. (2022). Alzheimer’s diagnostic imaging market analysis. Neuroimaging Journal, 18(4), 223–235.
2. U.S. Food and Drug Administration. (2018). FDA approves first PET scan to help assess Alzheimer’s disease. https://www.fda.gov/news-events/press-announcements
3. European Medicines Agency. (2020). Assessment report for tau PET imaging agents. https://www.ema.europa.eu
4. Eli Lilly. (2020). Tauvid (flortaucipir F18) approval and market report. https://investor.lilly.com
5. GlobalData. (2023). Alzheimer’s disease diagnostics market forecast. https://www.globaldata.com