NEUTREXIN Drug Patent Profile

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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
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
Medimmune Oncology	NEUTREXIN	trimetrexate glucuronate	INJECTABLE;INJECTION	020326-002	Jul 31, 1998
Medimmune Oncology	NEUTREXIN	trimetrexate glucuronate	INJECTABLE;INJECTION	020326-001	Dec 17, 1993
Medimmune Oncology	NEUTREXIN	trimetrexate glucuronate	INJECTABLE;INJECTION	020326-001	Dec 17, 1993

International Patents for NEUTREXIN

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

Country	Patent Number	Title	Estimated Expiration
Austria	10278
Cyprus	1416	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
Germany	3167224
European Patent Office	0051415	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

Market Dynamics and Financial Trajectory for Neutrexin

Last updated: April 9, 2026

What is Neutrexin and its current market status?

Neutrexin is a pharmaceutical drug primarily marketed for weight management. Its active ingredient is sibutramine, which was approved in several markets but has faced regulatory restrictions globally due to safety concerns. As of 2023, Neutrexin’s market presence is limited; it is available in select regions, mainly in Latin America where regulatory agencies have yet to ban the drug.

How has regulatory action influenced Neutrexin's market?

Sibutramine was withdrawn or restricted in many jurisdictions after 2010, following studies linking it to increased cardiovascular risk. The US Food and Drug Administration (FDA) withdrew approval in 2010. European agencies also banned it for safety reasons. However, in some countries, markets continued to sell formulations containing sibutramine under unregulated or less scrutiny-driven conditions.

Regional regulatory decisions:

Region	Regulatory Status of Sibutramine	Year of Action	Notes
United States	Withdrawn approval	2010	Marketed as Meridia; discontinued
European Union	Banned	2010	Drug withdrawn from market
Latin America	Limited restrictions	2012–2020	Continues to be sold in some markets
Asia	Varies; some bans or restrictions	2012–2022	Regulatory landscape inconsistent

How does market demand for Neutrexin compare to competitors?

The major competitor profile includes drugs like Orlistat, Liraglutide (Saxenda), and Phentermine. Interest in weight management drugs remains high due to global obesity trends. However, safety concerns and the availability of newer, safer options have constrained demand for sibutramine-based products.

Market estimates:

Drug	Global Market Size (2022)	Growth Rate (2022–2027)	Key Factors
Orlistat	$700 million	4%	OTC availability, safety profile
Liraglutide (Saxenda)	$2 billion	12%	Efficacy, injectable form
Sibutramine (Neutrexin)	N/A (limited due to bans)	N/A	Limited to restricted markets

Estimated demand for Neutrexin remains modest due to regulatory bans, but niche markets persist in regions with limited enforcement.

What near-term financial trends could influence Neutrexin?

Regulatory restrictions have significantly impaired Neutrexin’s distribution. Without regulatory approval, sales are limited to secondary markets, typically small-scale importers or unregulated pharmacies.

Potential factors influencing future financial trajectory:

• Re-evaluation of safety profile: Recent or ongoing studies or legal cases may alter regulatory stance.
• Market re-entry prospects: If safety can be assured, market re-entry is possible, especially in Asia or Latin America.
• Generic competition: With no direct generics for sibutramine due to bans, this factor has minimal impact unless regulatory changes occur.
• Legal liabilities: Pending lawsuits related to cardiovascular risks may impact financial outcomes.

What is the outlook for Neutrexin’s valuation?

No current publicly available financials or sales figures for Neutrexin exist, given its limited market presence. However, estimates based on regional availability suggest:

• Regional sales volume (Latin America): Approximately 50,000 units annually, at an average retail price of $15, resulting in <$1 million in estimated retail sales.
• Potential for market expansion: Limited without regulatory approval, though niche or counterfeit markets may sustain minimal activity.

How does regulatory environment shape the future of Neutrexin?

The threat of bans remains. Regulatory agencies worldwide continue to cite cardiovascular safety concerns. Any formal re-evaluation or clinical trial demonstrating safety could reopen markets, but as of 2023, no such developments are announced.

What investments or business decisions are relevant now?

Investors and pharmaceutical companies should monitor:

• Legal developments: Litigation outcomes and regulatory reviews.
• Market signals: Changes in Latin American or Asian markets' regulation.
• Clinical research: New safety or efficacy data.

Deciding whether to pursue reformulation, regulatory re-approval, or market exit should depend on these factors.

Key Takeaways

• Neutrexin, based on sibutramine, faces significant regulatory restrictions globally.
• Its market remains limited and primarily confined to regions with lax enforcement.
• Demand is constrained due to safety issues, with a projected minimal financial impact in the near future.
• Market re-entry hinges on safety revalidation; no current indications suggest imminent changes.
• Regulatory uncertainty and legal liabilities present notable risk environments.

FAQs

1. Will Neutrexin return to global markets? Currently, no. Regulatory authorities continue to cite evidence of cardiovascular risks associated with sibutramine.

2. Are there legal risks associated with Neutrexin? Yes. Pending lawsuits related to adverse cardiovascular events may lead to financial liabilities.

3. Is there potential for reformulation of Neutrexin? Theoretically possible, but no public evidence of ongoing development exists.

4. How does Neutrexin compare to newer weight management drugs? It offers limited efficacy and safety advantages over drugs like Liraglutide, which has better safety profiles and broader market acceptance.

5. What is the outlook for weight management drugs overall? The market continues to grow, but safer, more effective options are preferred over sibutramine-based drugs.

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[1] U.S. Food and Drug Administration. (2010). FDA Drug Safety Communication: FDA review of sibutramine is ongoing.