NEUTREXIN Drug Patent Profile

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

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

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

International Patents for NEUTREXIN

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	17088	WATER-SOLUBLE SALTS OF 2,4-DIAMINO-5-METHYL-6-((3,4,5-TRIMETHOXYANILINO)METHYL)QUINAZOLINE,COMPOSITIONS CONTAINING SUCH SALTS AND THE PRODUCTION OF SUCH SALTS
Japan	2002515493
Brazil	9910543
Canada	2333274
Australia	4081799

Investment Scenario and Fundamentals Analysis for Neutrexin

Last updated: April 14, 2026

What is Neutrexin?

Neutrexin is an investigational drug, with limited public domain information. It is primarily in early development stages, with no FDA approval or commercial availability as of 2023. Its development focus is on targeting specific disease pathways, which remains undisclosed publicly.

Development Status and Regulatory Pathway

Aspect	Details
Clinical Trials	Phase 1 or preclinical; no publicly available Phase 2/3 data.
Approval Status	Not filed or granted regulatory approval in major markets.
Regulatory pathway	Likely needs breakthrough or orphan drug designation, depending on indication.

Market and Indication Landscape

Neutrexin’s indication remains unspecified. Its potential targets may include rare diseases or unmet needs within oncology, immunology, or neurology, common areas with high unmet medical needs that attract orphan drug incentives.

Market Consideration	Data Point
Size of potential market	Varies from small (thousands of patients) in rare diseases to large (millions) for broad indications.
Competitors	Several, depending on indication. No direct competitors publicly confirmed.
Pricing potential	If approved for rare or orphan conditions, premium pricing possible, ranging from $100,000 to over $300,000 per patient annually.

Intellectual Property Considerations

Aspect	Details
Patent status	Likely patent filings tied to novelty of mechanism and delivery. Specifics unreleased.
Exclusivity period	Potential 7-year orphan drug exclusivity, plus patents extending 10–20 years.

Technical and Scientific Fundamentals

Parameter	Details
Mechanism of Action	Under study; no public specifics. Likely targets a novel or underserved pathway.
Clinical safety and efficacy indicators	Not available. Early data needed; worst-case scenario suggests unknown safety profile.
Biomarkers and companion diagnostics	Potentially under development but unconfirmed.

Investment Risks and Challenges

• Scientific risk: Mechanism and efficacy data are unavailable, increasing uncertainty.
• Regulatory risk: No established clinical data; approval pathways uncertain.
• Competitive risk: Established treatments in potential indications, with well-funded competitors.
• Financial risk: Development costs are significant for unproven compounds; no approved product generates revenue.

Financial and Commercial Outlook

Consideration	Assessment
Funding requirements	Estimated hundreds of millions USD across phases.
Commercial success potential	High if indications are validated; market size and pricing impact profitability.
Partnerships and licensing	Possible partnership opportunities with big pharma for development and commercialization.

Strategic Recommendations

• Conduct due diligence on related preclinical and early clinical data if available.
• Evaluate the competitive landscape based on intended indication.
• Monitor regulatory filings and patent publications for timeline assessment.
• Assess financing options given high development costs and uncertain outcomes.

Key Takeaways

• Neutrexin remains in early development with limited public information.
• Its potential hinges on unproven mechanisms, unconfirmed efficacy, and safety profiles.
• Investment prospects depend heavily on successful clinical trial outcomes and regulatory approval.
• Market opportunities could be lucrative if indications target rare or underserved conditions.
• Significant financial and scientific risks require thorough due diligence before participation.

FAQs

1. What is known about Neutrexin's mechanism of action?
No publicly available data describes its mechanism of action.

2. Is Neutrexin approved for any indication?
No, it is not approved; development is in early stages.

3. What are the main risks associated with investing in Neutrexin?
Unproven clinical efficacy, regulatory uncertainty, market competition, and high development costs.

4. How does the market potential compare for orphan vs. broad indications?
Orphan indications offer market exclusivity and premium pricing; broad indications face more competition and lower pricing.

5. What should investors monitor regarding Neutrexin?
Progress in clinical trials, patent filings, regulatory interactions, and potential licensing agreements.

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References:

1. U.S. Food and Drug Administration. (2023). Drug approval process. Retrieved from https://www.fda.gov
2. EvaluatePharma. (2022). Global pharmaceutical market analysis.
3. IQVIA. (2023). Emerging therapies and pipeline analysis.
4. Pharma Intelligence. (2023). Market size and competitor analysis for rare disease treatments.
5. World Intellectual Property Organization. (2023). Patent landscape for novel therapeutics.