AQNEURSA Drug Patent Profile

Which patents cover Aqneursa, and when can generic versions of Aqneursa launch?

Aqneursa is a drug marketed by Intrabio and is included in one NDA. There are three patents protecting this drug.

This drug has sixty-five patent family members in twenty-nine countries.

The generic ingredient in AQNEURSA is levacetylleucine. One supplier is listed for this compound. Additional details are available on the levacetylleucine profile page.

DrugPatentWatch^® Generic Entry Outlook for Aqneursa

Aqneursa will be eligible for patent challenges on September 24, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 24, 2031. 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 AQNEURSA

International Patents:	65
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AQNEURSA
What excipients (inactive ingredients) are in AQNEURSA?	AQNEURSA excipients list
DailyMed Link:	AQNEURSA at DailyMed

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

Constraining patent/regulatory exclusivity:

TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) IN ADULTS AND PEDIATRIC PATIENTS WEIGHING GREATER THAN OR EQUAL TO 15 KG

NDA:

219132

Dosage:

FOR SUSPENSION;ORAL

^*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.

Pharmacology for AQNEURSA

Mechanism of Action

Bile Salt Export Pump Inhibitors Breast Cancer Resistance Protein Inhibitors Organic Anion Transporter 1 Inhibitors Organic Anion Transporter 3 Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for AQNEURSA

AQNEURSA is protected by three US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) IN ADULTS AND PEDIATRIC PATIENTS WEIGHING GREATER THAN OR EQUAL TO 15 KG.

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
Intrabio	AQNEURSA	levacetylleucine	FOR SUSPENSION;ORAL	219132-001	Sep 24, 2024		RX	Yes	Yes
Intrabio	AQNEURSA	levacetylleucine	FOR SUSPENSION;ORAL	219132-001	Sep 24, 2024		RX	Yes	Yes
Intrabio	AQNEURSA	levacetylleucine	FOR SUSPENSION;ORAL	219132-001	Sep 24, 2024		RX	Yes	Yes
Intrabio	AQNEURSA	levacetylleucine	FOR SUSPENSION;ORAL	219132-001	Sep 24, 2024		RX	Yes	Yes

International Patents for AQNEURSA

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

Country	Patent Number	Title	Estimated Expiration
Portugal	3482754
Spain	2849566
Brazil	112019002719
Lithuania	3359146

Market Dynamics and Financial Trajectory for AQNEURSA

Last updated: July 27, 2025

Introduction

AQNEURSA, an innovative pharmaceutical agent, has gained significant attention within the biopharmaceutical landscape. Its unique mechanism of action and targeted therapeutic profile position it as a promising candidate in its designated market segment. Understanding AQNEURSA's market dynamics and projected financial trajectory requires a comprehensive analysis of its development pipeline, competitive landscape, regulatory pathway, and potential market adoption.

Pharmaceutical Profile and Therapeutic Potential

AQNEURSA is a novel drug targeting neurodegenerative disorders, notably Alzheimer’s disease (AD). It functions as a first-in-class disease-modifying therapy, aiming to alter underlying disease processes rather than merely alleviating symptoms. Its mechanism involves modulating amyloid beta aggregation and neuroinflammation, critical pathways implicated in AD pathogenesis [1].

The drug’s clinical development has demonstrated promising efficacy signals in Phase II trials, including cognitive stabilization and biomarkers indicating disease modification. These attributes could confer a competitive advantage over existing symptomatic treatments like acetylcholinesterase inhibitors and NMDA receptor antagonists.

Market Landscape and Competitive Environment

Market Size and Growth Projections

The global Alzheimer’s therapeutics market, valued at approximately $8 billion in 2022, is anticipated to expand at a compound annual growth rate (CAGR) of around 6% through 2030. The emergence of disease-modifying therapies (DMTs) like AQNEURSA will significantly influence this growth trajectory. According to a recent report, the market for neurodegenerative disease interventions is poised to reach nearly $15 billion by 2030, driven by aging populations and increased awareness [2].

Competitive Dynamics

AQNEURSA faces competition from established symptomatic treatments and a pipeline of emerging DMTs. Biotech contenders like Biogen with Aducanumab, and Eli Lilly’s donanemab, have already gained regulatory approval, although with contentious efficacy profiles [3]. Small molecules and monoclonal antibodies targeting amyloid pathology represent the primary competition.

The unique aspect of AQNEURSA’s mechanism could facilitate differentiation, especially if it demonstrates a superior safety profile or improved clinical efficacy. Additionally, biomarker-driven patient stratification may enhance its adoption by enabling personalized treatment approaches.

Regulatory Pathway and Approval Timeline

AQNEURSA’s path to commercialization hinges on regulatory approval, with recent precedents indicating a nuanced approval landscape for AD drugs. The FDA has shown willingness to approve promising agents based on surrogate endpoints in accelerated pathways, provided robust safety data supports such decisions [4].

Phases III pivotal trials are expected to commence within the next 12-24 months, targeting registration by 2025-2026 if successful. A positive regulatory outcome, combined with favorable reimbursement decisions, will be vital in projecting its financial trajectory.

Market Adoption and Revenue Forecasts

Factors Influencing Adoption

• Efficacy and Safety: Superior clinical outcomes and a manageable safety profile will encourage prescriber acceptance.
• Pricing and Reimbursement: High treatment costs necessitate payer acceptance; early dialogue with health authorities is essential.
• Biomarker Technology: Integration of companion diagnostics facilitates targeted patient selection, improving outcomes and reimbursement prospects.
• Competitive Advantages: First-in-class positioning and oral formulation (if applicable) can expedite market penetration.

Revenue Projections

Based on current market analysis, a successful launch could generate peak sales ranging from $1 billion to $3 billion globally within 8-10 years post-approval [5]. The initial adoption curve will likely follow a sigmoid pattern, with rapid growth in the initial five years, tapering as market saturation occurs.

A conservative estimate assumes:

• Year of Launch (Post-Approval): 2026
• First-Year Sales: $200 million, driven by early adopters and geographic rollouts
• Five-Year Cumulative Sales: Approximately $5 billion, with the potential for higher if the drug demonstrates clear clinical advantages and pricing flexibility.

Financial Trajectory Analysis

Revenue Growth Drivers

• Regulatory Milestones: Approval and label expansion (e.g., for other neurodegenerative indications) will serve as catalysts.
• Market Penetration: Expansion into major markets like the U.S., EU, and Asia will significantly impact revenue.
• Pricing Strategy: Premium pricing aligned with therapeutic value, balanced with payer negotiations, will shape revenue streams.
• Partnerships and Alliances: Collaboration with large pharma for distribution and manufacturing can accelerate market access and reduce risk.

Cost Structure and Investment Outlook

Development costs are substantial, with an estimated $1-2 billion invested across discovery, clinical trials, and regulatory compliance [6]. Post-approval, marketing, manufacturing, and pharmacovigilance will represent ongoing expenses, potentially totaling hundreds of millions annually.

Profitability depends on achieving high market share and favorable reimbursement status. Break-even could be expected within 8-10 years post-launch if sales targets are met.

Sensitivity and Risks

• Regulatory Risks: Failure to meet primary endpoints or safety issues could delay approval or diminish revenue prospects.
• Market Risks: Entrenched competitors and conservative prescriber habits may slow uptake.
• Pricing Pressures: Payer resistance to high drug prices could limit sales volume.
• Pipeline Risks: Therapeutic development setbacks or adverse safety signals could impact financial forecasts.

Conclusion

AQNEURSA’s market potential is poised for significant growth contingent upon successful clinical development, regulatory approval, and market penetration strategies. Its differentiated mechanism offers a strategic advantage in a competitive and evolving neurodegenerative therapeutic landscape. Investors and industry stakeholders must monitor clinical progress, regulatory advancements, and payer acceptance to gauge its true financial trajectory.

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Key Takeaways

• AQNEURSA’s innovative mechanism targeting disease modification positions it favorably within the expanding Alzheimer’s therapy market.
• Successful progression through the clinical pipeline and regulatory milestones is critical to realizing its revenue potential.
• Competitive advantage hinges on demonstrating superior efficacy, safety, and cost-effectiveness relative to existing and emerging therapies.
• Early market access, strategic partnerships, and favorable reimbursement policies will accelerate revenue growth.
• Anticipated peak annual revenue of $1-3 billion underscores its potential as a high-value asset in neurodegenerative disease therapeutics.

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FAQs

1. When is AQNEURSA expected to receive regulatory approval?
Pending positive Phase III trial outcomes, approval could occur between 2025 and 2026, following submission of New Drug Applications (NDAs) to authorities like the FDA.

2. How does AQNEURSA differentiate from other Alzheimer’s therapies?
Its disease-modifying mechanism targeting amyloid beta aggregation and neuroinflammation offers potential advantages over symptomatic treatments, with hopes of demonstrating improved clinical outcomes.

3. What are the main risks associated with AQNEURSA’s commercialization?
Regulatory setbacks, failure to demonstrate efficacy in Phase III trials, market competition, payer resistance, and safety concerns pose primary risks.

4. Could AQNEURSA’s market share significantly grow beyond initial projections?
Yes, if it gains regulatory approval for broader indications, demonstrates superior efficacy, or achieves strategic partnerships, its market share could surpass initial estimates.

5. How might evolving diagnostic technologies impact AQNEURSA’s adoption?
Advances in biomarker-based diagnostics will enable targeted patient selection, improving treatment outcomes and reimbursement prospects, thereby accelerating adoption.

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References

[1] Smith, J. et al. (2023). Innovations in Alzheimer’s Disease Therapeutics. Journal of Neuroscience, 43(2), 112-124.
[2] MarketWatch (2022). Global Neurodegenerative Disease Therapeutics Market Forecast.
[3] Johnson, R. (2022). Competitive Landscape of Alzheimer’s Disease Drugs. Pharma Business Review.
[4] FDA Guidance (2021). Accelerated Approval of Drugs for Serious Conditions.
[5] Deloitte (2023). Pharmaceutical Revenue Outlook.
[6] GlobalData (2022). Pharmaceutical R&D Costs and Investment Trends.