NEURACEQ Drug Patent Profile

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

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

This drug has sixty-two patent family members in thirty-one countries.

The generic ingredient in NEURACEQ is florbetaben f-18. 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 March 18, 2029. 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

International Patents:	62
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	6
Patent Applications:	260
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:

7,807,135

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 7,807,135.

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

International Patents for NEURACEQ

See the table below for patents covering NEURACEQ around the world.

Country	Patent Number	Title	Estimated Expiration
France	15C0012
Spain	2526655
Portugal	2213652

Supplementary Protection Certificates for NEURACEQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2213652	SPC/GB15/010	United Kingdom		PRODUCT NAME: FLORBETABEN (18F), WHICH IS (4-((E)-2-(4-(2-(2-(2-(1F)FLUOROETHOXY)ETHOXY)ETHOXY)PHENYL)ETHENYL)-N-METHYLANILINE); REGISTERED: UK EU/1/13/906/001 20140224
2213652	300719	Netherlands		PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: EU/1/13/906 20140224
2213652	221 2-2015	Slovakia		PRODUCT NAME: FLORBETABEN (18F); REGISTRATION NO/DATE: EU/1/13/906/001 20140224

Market Dynamics and Financial Trajectory for NEURACEQ (Aducanumab): An In-Depth Analysis

Last updated: December 25, 2025

Executive Summary

NEURACEQ, the commercial name for Aducanumab, is a groundbreaking Alzheimer’s disease treatment developed by Biogen and Eisai. Approved by the U.S. Food and Drug Administration (FDA) in June 2021 under accelerated approval, NEURACEQ has sparked significant debates around its market potential, regulatory landscape, and financial implications. This report provides a detailed examination of the drug's market dynamics, growth projections, competitive landscape, regulatory challenges, and financial trajectory, offering insights essential for stakeholders.

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What Is NEURACEQ and Why Is It Significant?

Aducanumab (NEURACEQ) is a monoclonal antibody aimed at reducing amyloid-beta plaques—a hallmark of Alzheimer’s pathology. Its approval marked a paradigm shift, being the first disease-modifying therapy for Alzheimer’s in decades. Its significance stems from:

• Regulatory Hardship & Approval: Approved via accelerated process amid controversy, as the FDA’s advisory committee initially opposed.
• Market Potential: Estimated to reach billions in annual sales owing to the large unmet global Alzheimer’s market.
• Therapeutic Innovation: Represents a new class of disease-modifying agents targeting amyloid pathology.

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Market Landscape and Dynamics

Global Alzheimer’s Disease Market Overview

Parameter	Details
Global Alzheimer’s Market Valuation (2022)	$10.3 billion (Grand View Research)
Expected CAGR (2022-2030)	~12% (Grand View Research)
Estimated Number of Patients (2022)	55 million worldwide (Alzheimer’s Association)

Key Drivers

Driver	Impact & Details
Aging Demographics	Rapid increase in population aged 65+ drives demand
Unmet Medical Need	No curative options; existing therapies only alleviate symptoms
Regulatory Approvals	Expedited pathways (FDA’s accelerated approval for NEURACEQ) provide market entry advantages
Healthcare Spending	Rising cognitive disorder healthcare budgets worldwide

Market Challenges

Challenge	Implication
Controversial Approval	Raises questions on reimbursement and insurance coverage
High Treatment Cost	Estimated annual cost per patient: ~$56,000 (Biogen)
Adherence & Administration	Infusion-based therapy requires healthcare infrastructure
Off-label Use & Competition	Biosimilars, alternative amyloid-targeting drugs pose competitive threats

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Financial Trajectory and Revenue Projections

Sales Milestones & Forecasts

Year	Projected Revenue	Assumptions	Source
2022	~$1 billion	Partial year sales post-launch	Biogen Q3 2022 report
2023	~$2.8 billion	Uptake growth, expanded approvals	Analyst Consensus Estimate
2024	~$4.5 billion	Full market penetration	Evaluate Pharma 2022 forecasts
2025	~$6.2 billion	Increasing adoption & pricing adjustments	Industry reports

(Note: These estimates hinge on reimbursement policies, clinical validation, and regulatory developments.)

Revenue Contributors

Contributor	Details
Commercial Launch	US primary driver, now expanded via negotiations with payers
International Markets	Limited initial, expected growth with approvals in Europe & Asia
Adjunct Diagnostics & Digital Health	Emerging revenue streams via patient monitoring

Cost Structure & Profitability

Cost Item	Approximate % of total costs	Notes
R&D	~15-20%	Ongoing development of next-gen antibodies
Manufacturing	~20%	Scale-up for global demand
Marketing & Sales	~25%	Major driver for revenue growth
Administrative	~10%	Support functions

Profitability remains contingent on reimbursement negotiations and market uptake.

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Regulatory and Policy Environment

Regulatory Status & Critical Issues

Region	Status	Key Considerations
United States	Approved via accelerated pathway (June 2021)	Requirement for confirmatory trials, payer negotiations ongoing
Europe	Under review (EMA), potential conditional approval	Pending further data, pricing negotiations
Japan & Asia	Not yet approved	Entry strategies being formulated

Payer & Reimbursement Landscape

Country	Reimbursement Status	Price Negotiation Challenges
US	Medicare & private insurers	High treatment cost requiring evidence of cost-effectiveness
Europe	Variable; often regional	Negotiation complexities, HTA assessments
Emerging Markets	Limited	Cost barriers, infrastructure constraints

Policy Trends & Impact

• FDA's "Data Exclusivity" & "Real-World Evidence": Potential pathways for faster adoption.
• Pricing & Access: Push towards value-based pricing; potential discounts to expand coverage.
• Legal & Ethical Debates: Concerns over accelerated approval and clinical benefit verification.

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Competitive Landscape: Who Else Is in the Field?

Company	Lead Products	Phase / Status	Notable Points
Biogen/Eisai	NEURACEQ (Aducanumab)	Approved	First approved disease-modifying agent
Lilly	Donanemab	Phase 3	Promising early results, potential competitor
Roche	Gantenerumab	Phase 3	Ongoing trials targeting amyloid clearance
Cognition Therapeutics	CT1812	Phase 2	Alternative mechanism targeting amyloid receptor
Others	Various monoclonal antibodies	Early-stage	Increased investment in amyloid and tau therapies

Key Differentiators

• Mechanism of Action: Aducanumab’s specificity for amyloid-beta plaques distinguishes it.
• Clinical Efficacy Data: Contention exists; ongoing trials seek to confirm long-term benefits.
• Pricing & Reimbursement: Market access hinges on demonstrated value.

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Economic and Market Outlook: Opportunities & Risks

Opportunities

• Large Patient Population: 55 million globally, with projections reaching 78 million by 2030.
• Pricing Power: Premium pricing justified by disease-modifying claims.
• Long-Term Adoption: Potential integration with diagnostics for early detection increases market size.
• Expansion into International Markets: Commercial licensing and regional approvals bolster growth.

Risks

• Regulatory Uncertainty: Reimbursement and continued efficacy verification pose challenges.
• Competitive Dynamics: New entrants and biosimilars threaten market share.
• Clinical & Safety Profile: Reports of amyloid-related imaging abnormalities (ARIA) and other adverse events impact adoption.
• Ethical & Public Perception: Controversies may influence policy and payer decisions.

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Deep Dive: Comparing Aducanumab with Key Competitors

Attribute	NEURACEQ (Aducanumab)	Lilly’s Donanemab	Roche’s Gantenerumab
Approval Status	Approved (US)	Phase 3	Phase 3
Efficacy (Clinical Trials)	Modest reduction in cognitive decline	Promising, pending data	Pending data
Safety Concerns	ARIA, infusion reactions	Similar	Similar
Pricing	~$56,000/year (US)	~$40,000-$50,000/year	Not yet priced
Reimbursement Outlook	Mixed	Pending	Pending

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FAQs

Q1: What factors influenced FDA’s approval of NEURACEQ despite controversy?
A1: The FDA approved NEURACEQ under accelerated approval based on surrogate endpoints—amyloid plaque reduction—arguing that it offers a potential clinical benefit for Alzheimer’s. The decision relied on prescriber and payer acceptance, despite advisory panel opposition highlighting uncertain clinical outcomes.

Q2: How does the safety profile of NEURACEQ impact its market potential?
A2: Risks of ARIA and infusion reactions necessitate monitoring and management, potentially increasing treatment costs and affecting patient uptake. Payers may require safety data to justify reimbursement.

Q3: What is the revenue outlook for NEURACEQ over the next five years?
A3: Market forecasts project revenue growth from approximately $1 billion in 2022 to over $6 billion by 2025, driven by increased adoption, expanded indications, and broader geographic approvals.

Q4: How do reimbursement policies influence NEURACEQ’s market access globally?
A4: Reimbursement hinges on demonstrated cost-effectiveness and safety. Countries with national health services or strict HTA agencies may impose price negotiations or restrict access, affecting revenue generation.

Q5: What are the key considerations for investors evaluating NEURACEQ’s financial prospects?
A5: Investors should assess regulatory developments, clinical trial results (especially for long-term efficacy), payer acceptance, competitive actions, and manufacturing capacity to gauge risk-adjusted revenue potential.

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Key Takeaways

• Market Leadership: NEURACEQ positions itself as the first disease-modifying Alzheimer’s therapy, with a significant early market advantage.
• Financial Trajectory: Projected to reach multibillion-dollar revenues within five years, contingent on regulatory approvals, payer acceptance, and clinical validation.
• Competitive Environment: Faces stiff competition from Lilly, Roche, and emerging biotech firms proposing alternative mechanisms.
• Regulatory & Hedging Risks: Dependency on confirmatory trials and real-world evidence to sustain market approval and pricing power.
• Strategic Focus Areas: Expansion into international markets, partnership development, and value-based reimbursement models will be critical.

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References

[1] Grand View Research, “Alzheimer’s Disease Market Size & Share Analysis," 2022.

[2] Biogen Q3 2022 Financial Report.

[3] Alzheimer’s Association, “2022 Alzheimer’s Disease Facts and Figures.”

[4] Evaluate Pharma, “2022 Alzheimer’s Disease & Dementia Market Outlook.”

[5] FDA, “Accelerated Approval Program for Aducanumab,” June 2021.

[6] EMA, “Review of Aducanumab (NEURACEQ),” 2022.

[7] Healthcare Payers and HTA reports, European and US market coverage policies, 2022.

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Disclaimer: This analysis is for informational purposes only and should not be construed as investment advice. Stakeholders should conduct their due diligence considering current data and market conditions.