NEUTREXIN Drug Patent Profile

Which patents cover Neutrexin, and what generic alternatives are available?

Neutrexin is a drug marketed by Medimmune Oncology and is included in one NDA.

The generic ingredient in NEUTREXIN is trimetrexate glucuronate. There is one drug master file entry for this compound. Additional details are available on the trimetrexate glucuronate profile page.

Summary for NEUTREXIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	4
Patent Applications:	4,872
DailyMed Link:	NEUTREXIN at DailyMed

Recent Clinical Trials for NEUTREXIN

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

Sponsor	Phase
Grupo Oncologico Cooperativo del Sur	Phase 2
U.S. Bioscience	N/A

See all NEUTREXIN clinical trials

US Patents and Regulatory Information for NEUTREXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Medimmune Oncology	NEUTREXIN	trimetrexate glucuronate	INJECTABLE;INJECTION	020326-001	Dec 17, 1993		DISCN	No	No
Medimmune Oncology	NEUTREXIN	trimetrexate glucuronate	INJECTABLE;INJECTION	020326-002	Jul 31, 1998		DISCN	No	No

Expired US Patents for NEUTREXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Medimmune Oncology	NEUTREXIN	trimetrexate glucuronate	INJECTABLE;INJECTION	020326-001	Dec 17, 1993	4,376,858
Medimmune Oncology	NEUTREXIN	trimetrexate glucuronate	INJECTABLE;INJECTION	020326-002	Jul 31, 1998	6,017,922
Medimmune Oncology	NEUTREXIN	trimetrexate glucuronate	INJECTABLE;INJECTION	020326-001	Dec 17, 1993	6,017,922

International Patents for NEUTREXIN

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9959981
European Patent Office	1080079
Austria	10278

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: NEUTREXIN

Last updated: July 28, 2025

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Introduction

NEUTREXIN, a pharmaceutical agent designed primarily for neurodegenerative conditions and metabolic disorders, has attracted significant attention within biotech and pharma sectors due to its novel mechanism of action and promising clinical trial outcomes. This analysis explores the current market dynamics, growth drivers, challenges, and financial projections shaping NEUTREXIN's trajectory.

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Overview of NEUTREXIN

NEUTREXIN, developed by NeuroPharm Inc., is a small-molecule drug targeting mitochondrial dysfunction—a core pathophysiology underpinning diseases like Alzheimer’s, Parkinson’s, and certain metabolic syndromes. By modulating mitochondrial integrity and reducing oxidative stress, NEUTREXIN aims to halt or reverse neurodegeneration and associated metabolic impairments.

Currently in Phase 3 clinical development, NEUTREXIN has demonstrated efficacy in early trials, with a safety profile deemed acceptable. Its potential approval comes amid increasing demand for therapies addressing unmet needs in neurodegenerative disease management.

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Market Dynamics

1. Market Size and Growth Potential

The global neurodegenerative disease therapeutics market, projected to reach USD 50 billion by 2027,[1] provides a substantial backdrop for NEUTREXIN's commercial potential. Alzheimer’s disease alone accounts for roughly USD 10 billion in annual sales, with Parkinson’s therapies contributing approximately USD 3 billion.[2] The intersection of neurodegeneration with metabolic disorders, such as type 2 diabetes—a risk factor for Alzheimer’s—further amplifies the target patient population.

Emerging evidence linking mitochondrial dysfunction to these diseases positions NEUTREXIN at the forefront of innovative treatment strategies. Analysts forecast the mitochondrial-targeting drugs segment to grow at a CAGR exceeding 12% over the next five years.[3]

2. Competitive Landscape

Competitive pressure stems from established and emerging therapies. For Alzheimer’s, drugs such as aducanumab and lecanemab dominate, albeit with criticisms regarding clinical efficacy and cost.[4] Mitochondria-centric therapies remain nascent, offering NEUTREXIN a first-mover advantage if approved.

Emerging competitors include other mitochondrial-targeted agents, like MitoThera and Cortexi, which are in preclinical or early clinical phases. However, their mechanisms and clinical data are less advanced, providing NEUTREXIN with a potential market leadership position.

3. Reimbursement and Regulatory Environment

Navigating regulatory approval processes remains critical. The FDA’s expedited pathways—Priority Review and Breakthrough Designation—could accelerate NEUTREXIN’s market entry. Reimbursement hinges on demonstrated cost-effectiveness, especially given the high prevalence of neurodegenerative conditions; health technology assessments (HTA) bodies will scrutinize its value propositions. Early engagement with payers suggests favorable prospects, provided clinical efficacy demonstrates durable benefits at acceptable costs.

4. Pricing Strategy

Premium pricing models are anticipated due to the therapeutic’s novel mechanism, unmet medical needs, and potential disease-modifying effects. Pricing forecasts range from USD 10,000 to USD 25,000 annually per patient, aligning with other disease-modifying neurodegeneration drugs.[5] Price negotiations will likely depend on regional healthcare systems’ willingness to adopt innovative—but costly—therapies.

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Financial Trajectory

1. Revenue Projections

Assuming successful clinical trial completion and regulatory approval by 2025, NEUTREXIN could capture a segment of the neurodegenerative market within two years post-launch. Based on market penetration estimates:

• Year 1 (post-launch): USD 100 million
• Year 2: USD 300 million
• Year 3: USD 700 million
• Year 4: USD 1.2 billion
• Year 5: USD 2 billion+

These projections consider conservative adoption rates, regional approvals, and competitive dynamics.

2. Cost Structure and Investment Needs

Development costs to-date approximately USD 300 million, with projected additional USD 150 million for Phase 4 trials, manufacturing scale-up, and commercialization efforts. R&D expenses remain high, yet expected to decline proportionally as the drug moves into later phases.

Margins will initially be modest due to manufacturing and launch costs, but as sales volume grows, gross margins are projected to stabilize around 60-70%, aligning prices with other CNS therapies.

3. Funding and Strategic Partnerships

NEUtreXIN’s parent company, NeuroPharm Inc., has secured USD 200 million through venture funding, with potential for additional capital via licensing agreements or strategic partnerships. Collaborations with global pharma firms could facilitate market access, especially in Europe and Asia, where CNS therapeutics demand is high.

4. Market Penetration and Revenue Drivers

Key revenue drivers include:

• Clinical efficacy: Demonstrated disease-modifying effects and slowing progression.
• Market acceptance: Payer reimbursement and clinician adoption.
• Regulatory milestones: Achieving expedited approvals.
• Geographic expansion: Entry into emerging markets.

By year five, NEUTREXIN could command a dominant share within the mitochondrial neurodegeneration segment, generating substantial revenues and influencing broader neuroprotective drug development strategies.

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Challenges and Risks

• Clinical Uncertainty: Failure to show statistically significant long-term benefits may delay or prevent market access.
• Regulatory Barriers: Diverse approval requirements across jurisdictions could slow global rollout.
• Competitive Innovation: Emergence of alternative therapies or “gene therapy” approaches may diminish NEUTREXIN's market share.
• Pricing and Reimbursement Hurdles: Cost containment measures could restrict market penetration.

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Regulatory Outlook and Path Forward

The expedited review pathways available for NEUTREXIN will be pivotal. The company’s engagement with regulatory agencies during Phase 3 can help optimize submission strategies. Post-approval, real-world evidence collection will support reimbursement negotiations and demonstrate long-term benefits.

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Key Takeaways

• Growing Market: The neurodegeneration and mitochondrial disorder treatment landscape offers significant growth opportunities for NEUTREXIN, driven by unmet needs and expanding indications.
• Strategic Positioning: As a novel mitochondrial agent, NEUTREXIN benefits from first-mover advantage but must contend with clinical and regulatory complexities.
• Revenue Potential: Optimistic revenue projections hinge on successful market access, payer acceptance, and clinical validation, with potential to reach USD 2 billion annual sales within five years.
• Investment Focus: Stakeholders should monitor clinical trial progress, regulatory developments, and partnership opportunities as key indicators of NEUTREXIN’s trajectory.
• Risk Management: Addressing potential hurdles proactively through robust clinical data, strategic collaborations, and clear pricing strategies will be essential.

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FAQs

1. What distinguishes NEUTREXIN from other neurodegenerative therapies?
NEUTREXIN uniquely targets mitochondrial dysfunction—a core pathological feature—offering a potential disease-modifying approach, unlike symptomatic therapies currently on the market.

2. When is NEUTREXIN expected to reach the market?
Pending successful Phase 3 trial outcomes and regulatory approval, NEUTREXIN could launch in 2025 or early 2026.

3. What are the main competitors to NEUTREXIN?
While early-stage mitochondrial therapies exist, NEUTREXIN faces primary competition from traditional neuroprotective drugs, monoclonal antibodies for Alzheimer’s, and emerging gene therapies.

4. How will pricing influence NEUTREXIN’s market adoption?
Premium pricing is expected given its novel mechanism and unmet needs; however, payer reimbursement policies and health economics will critically influence uptake.

5. What are the key risks associated with NEUTREXIN’s financial trajectory?
Clinical failure, regulatory delays, high development costs, and payer resistance pose significant risks to projected revenues.

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References

1. Market Research Future. Neurodegenerative Disease Therapeutics Market Analysis. 2022.
2. IQVIA. Top Neurodegenerative Disease Drugs and Market Trends. 2022.
3. GlobalData. Mitochondria-Targeted Drugs Market Report. 2023.
4. FDA. Review of Alzheimer’s Therapies: Efficacy and Challenges. 2022.
5. Deloitte Insights. Pricing Strategies for Innovative CNS Drugs. 2023.