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:	153
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 one 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
Ge Healthcare	VIZAMYL	flutemetamol f-18	INJECTABLE;INTRAVENOUS	203137-002	Oct 25, 2013		RX	Yes	Yes			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	203137-001	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	203137-002	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
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

Supplementary Protection Certificates for VIZAMYL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1611115	CA 2015 00009	Denmark		PRODUCT NAME: FLUTEMETAMOL (18F); REG. NO/DATE: EU/1/14/941 20140822
1611115	C300724	Netherlands		PRODUCT NAME: FLUTEMETAMOL (18 F); REGISTRATION NO/DATE: EU/1/14/941 20140822
1611115	15C0005	France		PRODUCT NAME: FLUTEMETAMOL (18 F); REGISTRATION NO/DATE: EU/1/14/941 20140822
1611115	C20150004 00139	Estonia		PRODUCT NAME: FLUTEMETAMOOL (18F);REG NO/DATE: EU/1/14/941 26.08.2014
2182988	CA 2015 00008	Denmark		PRODUCT NAME: RADIOAKTIVE ISOTOPER AF FLUTEMETAMOL, SAERLIGT FLUTEMETAMOL (18F); REG. NO/DATE: EU/1/14/941 20140822
2182988	C300723	Netherlands		PRODUCT NAME: FLUTEMETAMOL (18 F); REGISTRATION NO/DATE: EU/1/14/941 20140822

Last updated: July 3, 2026

VIZAMYL (florbetaben F-18) market dynamics, revenue trajectory, and competitive patent-driven risk outlook

VIZAMYL (florbetaben F 18) is a positron emission tomography (PET) amyloid imaging agent used in Alzheimer’s disease assessment of beta-amyloid neuritic plaque density. The market is driven by scan volume growth, reimbursement coverage for amyloid PET, and substitution risk from competing amyloid tracers. Commercial trajectory is constrained by (1) infrastructure requirements for on-site cyclotron or supply logistics, (2) payor coverage and utilization management, and (3) competitive dynamics across FDA-cleared amyloid PET agents and their evolving payer policies.

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How is VIZAMYL used in Alzheimer’s disease amyloid imaging, and what drives demand?

Direct answer: Demand is tied to the number of patients evaluated for Alzheimer’s disease pathology using amyloid PET, scaled by prescriber adoption, payer coverage, and clinical workflow fit.

Key clinical use case and intended population

• Indication (high level): Imaging of beta-amyloid neuritic plaque density in patients evaluated for Alzheimer’s disease and other causes of cognitive impairment.
• Market pull factors:
  • Diagnostic workup adoption in neurology and memory-disorder clinics.
  • Integration into treatment selection pathways and eligibility criteria for disease-modifying therapies that rely on biomarker confirmation.
  • Increased utilization when payers cover amyloid PET in appropriate diagnostic categories.

Operational demand constraints

• Tracer logistics: Florbetaben F 18 is time-sensitive (radioactive decay), which heightens the importance of regional supply chains and imaging center throughput.
• Equipment cadence: PET scanner availability and scheduling utilization materially affect monthly scan volumes.
• Patient throughput economics: PET reimbursement per scan must offset scanner time, radiopharmacy supply, and staff.

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What are the main market dynamics for amyloid PET imaging, and how does VIZAMYL compete?

Direct answer: Amyloid PET is a competitive multi-tracer market shaped by reimbursement coverage, formulary placement, and supply reliability. VIZAMYL competes against other FDA-cleared amyloid PET tracers that compete on site acceptance, workflow, and payer policy.

Competitive set and substitution vectors

VIZAMYL’s substitution risk is driven by:

• Tracer availability and delivery reliability to imaging sites.
• Site experience (protocol compatibility, imaging workflows, reporting templates).
• Payer policies that may prefer particular tracers or restrict “not medically necessary” usage.
• Relative adoption curves after launch waves for newer tracers.

Payer coverage and reimbursement

Amyloid PET utilization is sensitive to:

• Coverage determinations by Medicare and commercial plans.
• Prior authorization requirements.
• Edits that limit use to specific diagnostic contexts (e.g., cognitive impairment with uncertain etiology).

Hospital vs outpatient imaging center mix

• Hospitals often buy based on institutional radiopharmacy contracts and system purchasing.
• Outpatient imaging networks are more likely to move quickly among tracers based on contracting.

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What is the FDA regulatory status and labeling posture for VIZAMYL?

Direct answer: VIZAMYL is FDA-approved for amyloid imaging in Alzheimer’s disease assessment and is governed by PET radiopharmaceutical regulatory requirements, including product distribution controls and site-specific handling.

Regulatory fundamentals that influence commercial trajectory

• Radiopharmaceutical manufacturing constraints: Short half-life logistics and batch release cadence.
• Site handling compliance: Imaging centers must maintain proper radiological protocols and documentation.
• Label-driven utilization: Prescriber adherence to labeled use cases affects payer defensibility and utilization stability.

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What do the patent and exclusivity constraints imply for future VIZAMYL volume and price?

Direct answer: For brand drug economics, the key question is whether meaningful market exclusivity or long-tail IP barriers prevent generic or alternative competition. For radiopharmaceuticals, competition is typically constrained less by classic generic substitution mechanics and more by manufacturing complexity, regulatory pathways, and tracer supply capacity.

How exclusivity typically affects amyloid PET pricing

• Strong exclusivity supports pricing power early.
• As competition increases, net price tends to compress through:
  • contracting dynamics,
  • utilization management,
  • preferred formulary placement.

Where the practical barrier sits

• Supply chain scale and reliability can outperform legal exclusivity in shaping real-world share outcomes.
• Clinical and reimbursement inertia slows switching but does not eliminate it when payers standardize tracer preferences.

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What generic entry risks exist for VIZAMYL, and what is the competitive landscape impact?

Direct answer: Generic entry risk depends on whether viable alternative manufacturing and regulatory pathways can supply comparable imaging agents at scale. In amyloid PET, competitive entry is usually more about substitution among FDA-cleared alternatives than “true generic” substitution.

Substitution scenarios that pressure VIZAMYL economics

• Payers move to “preferred tracer” models.
• Imaging centers standardize protocols to simplify reporting and billing.
• New entrants expand distribution radius, reducing turnaround time and improving scan availability.

Biosimilar parallel is not directly applicable

Amyloid PET is a small-molecule radiopharmaceutical context, so biosimilar frameworks do not map cleanly.

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How does VIZAMYL compare with other FDA-cleared amyloid PET tracers on market risk?

Direct answer: Market risk concentrates around tracer switching. The tracer that achieves:

1. broad access to imaging centers,
2. payer coverage ease,
3. reliable supply, tends to gain share. VIZAMYL’s relative risk increases when competitors are contract-preferred or better distributed.

Decision criteria used by imaging providers

• Total cost per scan (including supply, waste, staff time).
• Throughput stability and delivery reliability.
• Interpretation/reporting workflow compatibility.
• Payer policy alignment.

Commercial implications

• Price erosion is typically gradual but can accelerate when payers implement stricter medical-necessity coverage tied to specific tracers.

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What patent litigation or settlement dynamics affect amyloid PET market share?

Direct answer: Competitive outcomes in radiopharmaceuticals are usually determined more by:

• distribution agreements,
• payer contracting,
• regulatory approvals, than by large-scale brand-versus-generic litigation.

What to look for in litigation signals

• Challenged patents or exclusivity wrappers that could affect regulatory clearance pathways.
• Agreements that lead to coordinated launch timing or supply constraints.

(No litigation dataset is provided here; a complete case-based chronology cannot be produced without verified court and patent docket records.)

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What is the most likely revenue trajectory for VIZAMYL under different market share scenarios?

Direct answer: The revenue trajectory follows scan volume and net pricing after contracting. Baseline growth hinges on amyloid PET utilization expansion; downside risk comes from tracer switching and net price compression under preferred contracting.

Scenario framework tied to controllable market variables

1. Upside case (volume-led):
   • stable payer coverage,
   • reliable supply,
   • continued adoption in diagnostic workflows.
2. Base case (mixed):
   • utilization grows modestly but net price compresses through contracting.
3. Downside case (share-led):
   • tracer switching accelerates, or payers restrict indications requiring alternative tracer usage patterns.

What changes net revenue most

• Net price per scan after rebates and payer contracting.
• Monthly scan capacity and utilization rate at imaging centers.
• Regional distribution success (time-to-scan affects scheduling and patient conversion).

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Which commercial levers can protect VIZAMYL share and revenue over time?

Direct answer: Share protection depends on payer contracting, imaging-center standardization, and distribution performance.

Commercial levers that matter

• Formulary positioning and reimbursement support in key payer networks.
• Training and reporting support for interpreting centers to reduce switching friction.
• Distribution expansion to reduce outage risk and maintain scan scheduling continuity.
• Contracting that aligns with imaging networks’ tracer protocol preferences.

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How do reimbursement policies translate into adoption curves for VIZAMYL?

Direct answer: Reimbursement determines utilization management and drives the speed at which providers adopt amyloid PET in routine diagnostic workups.

Utilization management patterns

• Prior authorization thresholds influence patient selection.
• Coverage expansions cause step increases in scan volumes.
• Denials and limits reduce recurring utilization and increase patient churn.

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What commercialization risks are specific to radiopharmaceutical supply and distribution for VIZAMYL?

Direct answer: Supply reliability and regional distribution capacity are major determinants of commercial stability because half-life and handling constraints affect operational throughput.

Operational risks

• Production outages or capacity constraints in radiopharmaceutical manufacturing.
• Logistics failures (temperature, timing, and chain-of-custody errors).
• Regional bottlenecks that force rescheduling and reduce recurring volume.

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Key Takeaways

• VIZAMYL’s market is defined by amyloid PET utilization, payer coverage, and imaging center throughput economics.
• Competitive risk is primarily tracer substitution via contracting and standardization, not classic “generic” substitution mechanics.
• Revenue trajectory is volume-driven with net pricing sensitivity to payer preferred-tracer policies.
• Radiopharmaceutical logistics and supply reliability materially impact share and monthly stability.

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FAQs

1. What reimbursement factors most influence amyloid PET utilization for Alzheimer’s diagnostic workflows?
2. How does tracer supply reliability affect scan scheduling and imaging center adoption?
3. What payer contracting mechanisms drive preferred-tracer switching among amyloid PET agents?
4. How do imaging protocol and reporting workflow standardization reduce switching risk for VIZAMYL?
5. What are the biggest drivers of net price erosion in the amyloid PET market over time?

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References

1. U.S. Food and Drug Administration. VIZAMYL (florbetaben F 18) prescribing information. FDA Label.