NEURACEQ Drug Patent Profile

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When do Neuraceq patents expire, and what generic alternatives are available?

Neuraceq is a drug marketed by Lantheus and is included in one NDA. There are two patents protecting this drug.

The generic ingredient in NEURACEQ is florbetaben f-18. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the florbetaben f-18 profile page.

DrugPatentWatch^® Generic Entry Outlook for Neuraceq

Neuraceq was eligible for patent challenges on March 21, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 14, 2032. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for NEURACEQ

US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	6
Patent Applications:	325
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NEURACEQ
What excipients (inactive ingredients) are in NEURACEQ?	NEURACEQ excipients list
DailyMed Link:	NEURACEQ at DailyMed

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

Constraining patent/regulatory exclusivity:

9,308,284

NDA:

204677

Dosage:

SOLUTION;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 NEURACEQ

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

Sponsor	Phase
Life Molecular Imaging GmbH	Phase 3
William Charles Kreisl	Phase 1/Phase 2
Ulsan University Hospital	N/A

See all NEURACEQ clinical trials

Pharmacology for NEURACEQ

Drug Class	Radioactive Diagnostic Agent
Mechanism of Action	Positron Emitting Activity

US Patents and Regulatory Information for NEURACEQ

NEURACEQ is protected by two US patents.

This potential generic entry date is based on patent 9,308,284.

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
Lantheus	NEURACEQ	florbetaben f-18	SOLUTION;INTRAVENOUS	204677-001	Mar 19, 2014		RX	Yes	Yes	7,807,135		Y	Y
Lantheus	NEURACEQ	florbetaben f-18	SOLUTION;INTRAVENOUS	204677-001	Mar 19, 2014		RX	Yes	Yes	9,308,284		Y

International Patents for NEURACEQ

When does loss-of-exclusivity occur for NEURACEQ?

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

Australia

Brazil

Canada

China

Croatia

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Malaysia

Mexico

New Zealand

Poland

Portugal

Russian Federation

Slovenia

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 NEURACEQ around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2005316421	Stilbene derivatives and their use for binding and imaging amyloid plaques
Brazil	PI0516408	derivados de estilbeno e seu uso para ligação e formação de imagem de placas de amilóide
Canada	2591534	DERIVES DE STILBENE ET LEUR UTILISATION POUR LA LIAISON ET L'IMAGERIE DE PLAQUES AMYLOIDES (STILBENE DERIVATIVES AND THEIR USE FOR BINDING AND IMAGING AMYLOID PLAQUES)
China	101123995	Stilbene derivatives and their use for binding and imaging amyloid plaques
Costa Rica	9206	DERIVADOS DE ESTILBENO Y SU USO PARA ESTUDIOS DE UNION Y POR IMAGENES DE PLACAS AMILOIDES
Denmark	2213652

Supplementary Protection Certificates for NEURACEQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2213652	C300719	Netherlands		PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: EU/1/13/906 20140220
2213652	CA 2015 00018	Denmark		PRODUCT NAME: FLORBETABEN (18F); REG. NO/DATE: EU/1/13/906/001 20140220
2213652	C20150010 00142	Estonia		PRODUCT NAME: FLORBETABEEN (18F);REG NO/DATE: EU/1/13/906 24.02.2014
2213652	PA2015005	Lithuania		PRODUCT NAME: FLORBETABENUM (18F); REGISTRATION NO/DATE: EU/1/13/906/001 20140220
2213652	92647	Luxembourg		PRODUCT NAME: FLORBETABEN (18F). FIRST REGISTRATION: 20140224
2213652	15C0012	France		PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: EU/1/13/906/001 20140224

NEURACEQ (florbetaben F 18) Market Dynamics and Financial Trajectory: Competitive Landscape, Coverage, and Launch Risk

Last updated: July 22, 2026

NEURACEQ (florbetaben F 18) is a PET imaging agent for cerebral amyloid beta detection. Commercial performance depends on (1) adoption of amyloid PET in diagnostic pathways, (2) payer coverage and site throughput economics, (3) competition from NAVIGATOR-like scanners and alternative amyloid PET agents, and (4) the pace of reimbursement-linked guideline change tied to Alzheimer’s disease treatment. The financial trajectory is also shaped by short half-life logistics, dependence on radiopharmacy capacity, and the intensity of brand-to-brand and brand-to-test substitution in dementia workups.

What is Neuraceq (florbetaben F 18) used for and how does that drive market demand?

Neuraceq is indicated for brain imaging to detect amyloid beta neuritic plaque density in patients who have cognitive impairment and other signs suggesting Alzheimer’s disease. In practice, amyloid PET demand scales with diagnostic confirmation needs in outpatient neurology and specialty memory clinics, plus hospital neurology volumes.

Demand drivers

• Diagnostic pathway role: Amyloid PET is used when clinicians need more than clinical evaluation and structural imaging, such as to clarify Alzheimer’s probability versus other dementias.
• Treatment eligibility: The growing adoption of disease-modifying therapies increases demand for biomarker-supported diagnosis, especially where reimbursement covers confirmatory biomarker testing.
• Clinic workflow fit: PET slots, scheduling availability, and radiotracer supply reliability influence utilization more than pure incidence.

Demand constraints

• Radiotracer logistics: F 18 manufacturing and distribution require cold-chain and same-day workflow alignment. Throughput and turnaround time govern economics at nuclear medicine sites.
• Reimbursement variability: Coverage policies by payer and by indication window (diagnostic utility) can materially cap accessible volumes.
• Substitution risk: Where blood-based biomarkers or CSF testing become reimbursed at scale, amyloid PET volumes can shift.

How does reimbursement and payer coverage shape Neuraceq sales and profitability?

For amyloid PET agents, payer policy is a primary determinant of unit volume and net price realization. Sales performance typically reflects a mix of commercial reimbursement, Medicare coverage determinations (local policies), and managed care edits.

Key reimbursement mechanics that affect revenue

• Medical necessity criteria: Policies often limit imaging to specific stages of cognitive impairment or to diagnostic ambiguity. Tight criteria reduce addressable volume.
• Prior authorization: Utilization friction lowers conversion from referral to performed scan.
• Facility reimbursement: Even when drug costs are covered, site professional and technical components can shift total reimbursement economics and may influence which tracer brands are stocked.

Margin dynamics

• Radiopharmacy channel economics: Gross margin is influenced by production cost, distribution, and the negotiated channel structure with nuclear medicine providers and imaging networks.
• Service intensity and slot utilization: PET rooms and scanner schedules can make fixed costs dominant. A tracer’s ability to maintain high slot utilization affects profitability even if reimbursement is stable.

Which drugs compete with Neuraceq in amyloid PET, and how do those dynamics affect pricing and share?

Neuraceq competes in the amyloid PET market, where multiple brands vie for diagnostic share. Competition tends to be strongest at high-volume imaging networks and hospital systems that standardize tracer procurement.

Competitive dimensions

• Clinical perception and guideline fit: Uptake correlates with how clinicians interpret image results and the perceived ease of workflow.
• Network contracting: Large imaging providers negotiate pharmacy or tracer procurement and can favor one brand for budget and inventory predictability.
• Availability reliability: Supply consistency impacts whether a network adopts or abandons a tracer brand.

Substitution pressure sources

• Alternative amyloid tracers: Competitive PET agents can pull volume via “standardization” decisions by large providers.
• Biomarker substitution: Expanding blood-based biomarker adoption can reduce the need for confirmatory amyloid PET when reimbursed.

What is the patent and exclusivity situation for Neuraceq, and when does exclusivity expire?

NEURACEQ is typically discussed in the context of radiopharmaceutical regulatory and IP timelines tied to formulation, manufacturing, and method-use rather than classic long-duration oral-drug exclusivity structures. A precise exclusivity and expiration timeline requires a complete Orange Book and patent family record, including listed patents and regulatory exclusivity codes.

No complete Orange Book patent listing set and specific expiration dates are provided in the prompt, so a concrete “when does exclusivity expire” answer cannot be produced without risking factual error.

What is the Orange Book status of Neuraceq, and are there Paragraph IV challenges or biosimilar risks?

A reliable Orange Book status summary depends on the published FDA listing for NEURACEQ and any active patent entries, including the application reference number, patent expiration dates, and exclusivity periods.

No Orange Book listing identifiers or patent list details are included in the prompt, so a definitive statement about Orange Book status and Paragraph IV activity cannot be produced.

What formulation, manufacturing, and method-of-use patents protect florbetaben F 18?

For radiopharmaceuticals, IP often spans:

• drug substance and radiolabeling chemistry,
• production methods and purification steps,
• formulation parameters that preserve radiochemical purity and stability,
• use patents tied to diagnostic interpretation workflows and target populations.

However, without an enumerated patent estate and listed or relevant families, the number of patents and the claims’ scope cannot be stated accurately.

How do FDA regulatory status and labeling influence Neuraceq market uptake?

Labeling shapes payer coverage and clinician adoption. For amyloid PET, labeling language and intended patient characteristics affect which cohorts qualify under payer medical necessity criteria.

Uptake linkage

• Eligibility alignment: If labeling aligns tightly with payer criteria, more scans get approved and scheduled.
• Indication sequencing: If clinicians use other tests first, the labeling can still support later-line confirmation biomarker selection.

What litigation or settlement activity affects generic or competition risk for Neuraceq?

Radiopharmaceutical competition risk depends heavily on whether ANDA-like pathways exist for the specific reference listed product and on the practical and IP barriers to manufacturing the short half-life tracer to required specifications.

No case docket information, litigation captions, or settlement terms are included in the prompt, so a litigation impact analysis cannot be produced without introducing inaccuracies.

How does Neuraceq compare with competing amyloid PET products on commercial traction and network adoption?

A high-quality comparison requires:

• market share or unit volume data by tracer brand,
• contract award patterns in major imaging networks,
• payer formulary placement or preferred-tracer policies,
• price and net-to-gross details.

Those data are not provided in the prompt, so a quantified brand-by-brand comparison cannot be completed.

What generic entry risks exist for Neuraceq, and what manufacturing/IP barriers matter most?

For radiolabeled tracers, “generic” entry is constrained less by simple bioequivalence and more by:

• radiolabeling process reproducibility and radiochemical purity,
• short half-life operational scaling,
• validated quality systems at production sites,
• method-of-use claim exposure in litigation and patent estates.

Without the specific patent list, regulatory pathway information, and any documented competitor developments, entry-risk quantification would require unverifiable assumptions.

What are the revenue exposure and financial trajectory expectations for Neuraceq across the next 3–5 years?

A financial trajectory model requires actual historical revenue, volume, net price, and cost trend inputs, plus explicit milestone risks (loss of exclusivity, tender losses, payer policy changes, and competition entry). The prompt does not include any of these metrics.

As a result, any attempt to project sales growth, contraction, or profitability trajectory would be speculative and not usable for investment or licensing decisions.

Key Takeaways

• NEURACEQ’s market dynamics are dominated by amyloid PET diagnostic pathway adoption, payer medical necessity policies, and radiopharmacy operational constraints.
• Competitive impact is driven by imaging network contracting, tracer availability reliability, and the pace of substitution by alternative amyloid PET agents and reimbursed non-PET biomarkers.
• The financial trajectory depends on reimbursement and utilization stability more than on classic oral-drug-style exclusivity structures, but a specific exclusivity, Orange Book, and litigation timeline cannot be stated from the provided information.
• A usable financial model requires validated commercial history and an enumerated IP/regulatory record, neither of which is included in the prompt.

FAQs

1. How does amyloid PET reimbursement policy differ between Medicare and commercial plans for NEURACEQ?
2. What imaging network factors determine tracer selection for amyloid PET, including throughput and supply reliability?
3. Do blood-based Alzheimer’s biomarkers reduce NEURACEQ demand, and through which reimbursed diagnostic pathways?
4. What types of patents typically constrain entry for radiolabeled PET tracers like florbetaben F 18?
5. How do manufacturing batch release metrics and radiochemical purity standards affect pricing and competitive viability?

References