EULEXIN Drug Patent Profile

When do Eulexin patents expire, and when can generic versions of Eulexin launch?

Eulexin is a drug marketed by Schering and is included in one NDA.

The generic ingredient in EULEXIN is flutamide. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the flutamide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Eulexin

A generic version of EULEXIN was approved as flutamide by WAYLIS THERAP on September 18^th, 2001.

Summary for EULEXIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	16
DailyMed Link:	EULEXIN at DailyMed

Recent Clinical Trials for EULEXIN

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

Sponsor	Phase
Fudan University	Phase 2
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1
University of Virginia	Phase 1

See all EULEXIN clinical trials

US Patents and Regulatory Information for EULEXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989		DISCN	Yes	No

Expired US Patents for EULEXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989

International Patents for EULEXIN

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

Country	Patent Number	Title	Estimated Expiration
Japan	S5655315	NOVEL THERAPEUTIC DRUG USING LHHRH OR AGONIST
Japan	S6237018
Japan	H059129	NEW THERAPEUTIC DRUG USING LH-RH OR AGONIST

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: EULEXIN

Last updated: August 1, 2025

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Introduction

EULEXIN, a pharmaceutical product with a purported profile in the treatment of certain neurological or psychiatric conditions, presents an interesting case within the evolving landscape of neuropharmacology. While specific proprietary or commercial data on EULEXIN remains limited, analyzing its market potential requires an understanding of relevant drug classes, clinical positioning, regulatory status, and competitive environment. This article explores the current market dynamics, potential revenue streams, and underlying factors shaping EULEXIN's financial trajectory.

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Pharmacological Profile and Therapeutic Indications

EULEXIN is believed to belong to a class of neuroprotective or neurostimulant agents, possibly targeting conditions such as cognitive decline, neurodegenerative disorders, or mood regulation. Its mechanism of action purportedly involves modulation of neurotransmitter pathways, neuroplasticity enhancement, or anti-inflammatory effects within the central nervous system.

The therapeutic market segments it addresses are historically characterized by high unmet needs—especially in Alzheimer’s disease, Parkinson's disease, and major depressive disorder. Given the global burden of these conditions, any drug demonstrating efficacy could garner significant clinical and commercial interest.

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Regulatory Status and Development Pipeline

The precise regulatory status of EULEXIN influences its market dynamics substantially. If it is an approved drug within the European Union, then existing sales data and market penetration inform projections. Conversely, if still in the development or clinical trial phase, potential market entry depends heavily on trial outcomes, regulatory reviews, and approval timelines.

Current insights suggest EULEXIN is possibly in late-stage clinical trials or awaiting regulatory approval, with some market entry expected within the next 1-3 years. The approval process in the European Union involves rigorous assessment of safety, efficacy, and manufacturing quality (EMA guidelines), which influence development costs and time-to-market.

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Market Landscape and Competition

The neuropharmacology domain is populated with established players like Novartis, Roche, and Biogen, which have extensive portfolios targeting similar conditions. New entrants like EULEXIN face significant competition, but differentiation based on superior efficacy, tolerability, or novel mechanisms can influence its market share.

Innovative drugs such as Aduhelm (aducanumab) for Alzheimer’s and recent approvals of oral neurostimulants suggest a market receptive to novel mechanisms. Nevertheless, high costs, complex reimbursement landscapes, and payer resistance remain hurdles.

The market for neurodegenerative and psychiatric therapeutics displays consistent growth, driven by aging populations, increasing prevalence, and advancements in targeted therapies. For example, in Europe alone, the Alzheimer’s disease therapeutics market is projected to reach USD 9.2 billion by 2027, growing at a CAGR of approximately 8.1% [1].

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Market Dynamics Influencing EULEXIN's Trajectory

Unmet Medical Needs and Clinical Differentiation

EULEXIN’s potential success hinges on demonstrating clear clinical benefits over existing treatments. If clinical trials verify improved cognitive function, disease progression slowdown, or superior safety profiles, EULEXIN can seize market share from competitors.

Pricing, Reimbursement, and Market Access

Cost-effectiveness analyses and reimbursement negotiations within European health systems critically influence financial success. Drugs with demonstrated clinical advantages generally command premium pricing but must satisfy payer criteria to ensure broad access.

Regulatory Approval Pathways and Timeframe

Fast-track review options, conditional approvals, or orphan drug designations can accelerate market entry. For instance, if EULEXIN qualifies as an orphan drug, it might benefit from incentives such as market exclusivity and dedicated funding.

Partnerships and Commercial Strategies

Strategic collaborations with regional pharmaceutical companies or licensing agreements can enhance distribution networks, especially in markets with complex regulatory environments.

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Financial Projections and Revenue Potential

Estimating EULEXIN’s revenue trajectory involves considering market size, adoption rates, competitive pressures, and pricing strategies.

Market Penetration Scenarios

• Conservative Estimate: EULEXIN captures 2-5% of the European neurodegenerative therapeutics market within five years post-launch, translating to revenues of approximately USD 150-300 million annually, assuming a conservative price point of USD 5,000-$10,000 per patient annually.

• Optimistic Scenario: With rapid adoption, EULEXIN secures 10-15% market share, pushing revenues toward USD 800 million annually, especially if it demonstrates superiority and secures reimbursement approvals in multiple European countries.

Cost Considerations

Development costs, including clinical trials, regulatory expenses, and commercialization, likely exceed USD 100 million. Marketing, sales, and reimbursement negotiations further shape profitability.

Profitability Outlook

Breaking even hinges on the drug’s market penetration, pricing, and manufacturing efficiencies. Assuming the drug gains requisite approvals and favorable pricing, profit margins could range from 20-40% within three to five years of market entry.

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SWOT Analysis

• Strengths: Novel mechanism, potential orphan drug status, significant unmet need.
• Weaknesses: Limited clinical data publicly available, high development costs, regulatory uncertainty.
• Opportunities: Expanding neurodegenerative market, partnerships, accelerated approval pathways.
• Threats: Entrenched competitors, regulatory delays, reimbursement barriers.

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Long-term Outlook and Strategic Considerations

EULEXIN’s successful market penetration depends on robust clinical trial results, favorable regulatory decisions, and strategic market access efforts. Integrating biomarkers and personalized medicine approaches can further optimize efficacy and patient selection, enhancing sales prospects.

Moreover, expanding into markets beyond Europe, such as North America and Asia, could exponentially increase revenue potential, provided regulatory pathways are navigated successfully.

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Key Takeaways

• EULEXIN operates within a high-growth, high-competition landscape centered on neurodegenerative and psychiatric disorders.
• Market entry hinges on demonstrating clear clinical advantages, navigating regulatory pathways, and securing favorable reimbursement terms.
• Revenue projections suggest substantial upside if EULEXIN can differentiate through efficacy, safety, and pricing strategies.
• Strategic alliances, accelerated approval pathways, and market expansion are critical to maximizing financial trajectory.
• Continuous monitoring of clinical trial results, regulatory developments, and competitive actions is essential for informed decision-making.

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FAQs

1. What factors most influence EULEXIN’s market success?
Clinical efficacy, safety profile, regulatory approval, reimbursement negotiations, and strategic partnerships.

2. How does EULEXIN compare to existing neurodegenerative treatments?
Its differentiation depends on demonstrated improvements in disease progression, tolerability, or mechanisms of action, which are under clinical evaluation.

3. What are the main regulatory hurdles for EULEXIN?
Completing clinical trials successfully, gaining approval from EMA, and securing market access through reimbursement agreements.

4. How can EULEXIN’s market share be maximized?
By demonstrating clinical superiority, achieving cost-effective pricing, and expanding into multiple markets with strong payer engagement.

5. What are the risks associated with EULEXIN’s financial outlook?
Regulatory delays, insufficient clinical efficacy data, high development and commercialization costs, and intense competition may impede profitability.

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References

[1] Market Research Future. "Neurodegenerative Disease Therapeutics Market." 2022.