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:	7
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
Luxembourg	88603
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
Japan	S5799574	2,4-DIAMINO-5-METHYL-6-((3,4,5- TRIMETHOXYANILINO)METHYL)-QUINAZOLINE SALTS
World Intellectual Property Organization (WIPO)	9959981
Netherlands	950003

NEUTREXIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Neutrexin

Introduction to Neutrexin

Neutrexin, also known as trimetrexate glucuronate, is a drug used primarily for the treatment of moderate to severe Pneumocystis carinii pneumonia (PCP) in immunocompromised patients, including those with AIDS who are intolerant of or refractory to trimethoprim-sulfamethoxazole therapy[4].

Clinical Use and Indications

Neutrexin is indicated as an alternative therapy for PCP, particularly in patients who cannot tolerate or have failed other treatments. It is administered with concurrent leucovorin to mitigate its toxic effects. The drug has shown efficacy in clinical trials, with survival rates varying based on patient conditions and prior treatments[4].

Market Dynamics

Competitive Landscape

The market for treatments of PCP is relatively niche, with a few key players offering alternative therapies. Neutrexin competes with other antiparasitic and antimicrobial agents, such as trimethoprim-sulfamethoxazole and pentamidine. The competitive landscape is influenced by the availability of these alternatives, their efficacy, and the specific patient populations they target.

Regulatory Environment

The regulatory approval and ongoing monitoring of Neutrexin are crucial factors in its market dynamics. The drug has undergone clinical trials and has been approved for specific indications. Regulatory bodies continue to oversee its use, ensuring it meets safety and efficacy standards.

Patient Population and Demand

The demand for Neutrexin is driven by the need for effective treatments for PCP in immunocompromised patients. The HIV/AIDS epidemic and other conditions leading to immunosuppression contribute to the demand for this drug. However, the patient population is relatively small compared to other therapeutic areas, which can limit market growth.

Financial Trajectory

Revenue and Sales

Detailed financial data specifically for Neutrexin is not readily available, as it is often bundled within the broader financial reports of its manufacturer or distributor. However, the revenue generated by Neutrexin would be influenced by factors such as the number of patients treated, the cost of the drug, and the competition from other treatments.

Cost and Pricing

The cost of Neutrexin is a significant factor in its financial trajectory. The drug is administered in a hospital setting or under close medical supervision, which can add to its overall cost. Pricing strategies are often influenced by the drug's efficacy, the availability of alternatives, and the regulatory environment.

Research and Development

While Neutrexin itself may not be in the active development phase, ongoing research in antiparasitic and antimicrobial therapies can impact its market. New treatments or improvements in existing therapies could either complement or compete with Neutrexin, affecting its financial performance.

Challenges and Opportunities

Side Effects and Toxicity

Neutrexin is associated with severe side effects, including hematologic, hepatic, renal, and gastrointestinal toxicities. These side effects can limit its use and impact patient compliance, which in turn affects sales and revenue[4].

Market Expansion

Despite the niche market, there are opportunities for expansion, particularly in regions with high HIV/AIDS prevalence or other immunosuppressive conditions. Increasing awareness and access to healthcare in these regions could drive demand for Neutrexin.

Key Takeaways

• Niche Market: Neutrexin operates in a specialized market treating PCP in immunocompromised patients.
• Regulatory Approval: The drug's approval and ongoing regulatory oversight are critical for its market presence.
• Competition: Neutrexin competes with other treatments for PCP, influencing its market share.
• Side Effects: The drug's toxicity profile is a significant factor in its use and market dynamics.
• Financial Performance: Detailed financial data is not publicly available, but the drug's revenue is influenced by patient demand, competition, and pricing.

FAQs

1. What is Neutrexin used for? Neutrexin is used for the treatment of moderate to severe Pneumocystis carinii pneumonia (PCP) in immunocompromised patients, particularly those with AIDS who are intolerant of or refractory to trimethoprim-sulfamethoxazole therapy.

2. What are the common side effects of Neutrexin? Neutrexin is associated with severe side effects, including hematologic, hepatic, renal, and gastrointestinal toxicities.

3. How is Neutrexin administered? Neutrexin is administered with concurrent leucovorin to mitigate its toxic effects. It can be given intravenously or orally, depending on the patient's condition.

4. What is the competitive landscape for Neutrexin? Neutrexin competes with other antiparasitic and antimicrobial agents, such as trimethoprim-sulfamethoxazole and pentamidine.

5. Is Neutrexin still in active development? Neutrexin itself is not in the active development phase, but ongoing research in antiparasitic and antimicrobial therapies can impact its market.

Cited Sources

[4] https://www.rxlist.com/neutrexin-drug.htm