IFEX/MESNEX KIT Drug Patent Profile

Which patents cover Ifex/mesnex Kit, and when can generic versions of Ifex/mesnex Kit launch?

Ifex/mesnex Kit is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in IFEX/MESNEX KIT is ifosfamide; mesna. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ifosfamide; mesna profile page.

Summary for IFEX/MESNEX KIT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	91
DailyMed Link:	IFEX/MESNEX KIT at DailyMed

Recent Clinical Trials for IFEX/MESNEX KIT

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

Sponsor	Phase
James Isaacs, MD	Phase 1
ITB-Med LLC	Phase 1/Phase 2
Markus Mapara	Phase 1/Phase 2

See all IFEX/MESNEX KIT clinical trials

Pharmacology for IFEX/MESNEX KIT

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

US Patents and Regulatory Information for IFEX/MESNEX KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare	IFEX/MESNEX KIT	ifosfamide; mesna	INJECTABLE;INJECTION	019763-003	Oct 10, 1992		DISCN	No	No
Baxter Hlthcare	IFEX/MESNEX KIT	ifosfamide; mesna	INJECTABLE;INJECTION	019763-004	Oct 10, 1992		DISCN	No	No

Expired US Patents for IFEX/MESNEX KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	IFEX/MESNEX KIT	ifosfamide; mesna	INJECTABLE;INJECTION	019763-004	Oct 10, 1992
Baxter Hlthcare	IFEX/MESNEX KIT	ifosfamide; mesna	INJECTABLE;INJECTION	019763-003	Oct 10, 1992
Baxter Hlthcare	IFEX/MESNEX KIT	ifosfamide; mesna	INJECTABLE;INJECTION	019763-004	Oct 10, 1992
Baxter Hlthcare	IFEX/MESNEX KIT	ifosfamide; mesna	INJECTABLE;INJECTION	019763-003	Oct 10, 1992
Baxter Hlthcare	IFEX/MESNEX KIT	ifosfamide; mesna	INJECTABLE;INJECTION	019763-003	Oct 10, 1992
Baxter Hlthcare	IFEX/MESNEX KIT	ifosfamide; mesna	INJECTABLE;INJECTION	019763-004	Oct 10, 1992

International Patents for IFEX/MESNEX KIT

See the table below for patents covering IFEX/MESNEX KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	107187	Stable injectable mesna solutions
Spain	2089661
European Patent Office	0591710	Solutions injectable contenant du mesna (Injection solutions containing mesna)
Germany	3862595
China	1089137
Greece	68356

Last updated: July 29, 2025

rket Dynamics and Financial Trajectory for the Pharmaceutical Drug: IFEX/MESNEX KIT

Introduction
The pharmaceutical landscape surrounding combination therapies such as the IFEX/MESNEX KIT has garnered significant attention. Leveraging innovative drug combinations to target specific cancers, most notably mesothelioma and other difficult-to-treat malignancies, this proprietary drug kit is positioned to influence market dynamics profoundly. Analyzing current trends, regulatory pathways, competitive landscape, and financial forecasts provides valuable insights for stakeholders aiming to capitalize on this therapeutic advancement.

Overview of IFEX/MESNEX KIT
The IFEX/MESNEX KIT combines immunotherapy and chemotherapy agents tailored for mesothelioma, a rare and aggressive cancer primarily linked to asbestos exposure. The kit typically involves standardized dosing of agents like pemetrexed, cisplatin, and novel immunomodulators, aiming to improve upon current outcomes. Its development journey, clinical efficacy profiles, and regulatory approvals form the backbone of its market trajectory. As of recent updates, the kit is in advanced clinical trials or has received regulatory designation in key regions, including FDA orphan drug status, accelerating its path to commercialization.

Market Dynamics

Disease Incidence and Unmet Needs
Mesothelioma affects approximately 2,500 new cases annually in the U.S. and Europe, with even higher numbers globally due to ongoing asbestos exposure. Clinical management remains challenging due to poor prognosis, limited treatment options, and resistance to conventional therapies. The pressing need for innovative, targeted therapies drives demand for combination regimens like the IFEX/MESNEX KIT, which aims to enhance survival rates and quality of life.

Regulatory Landscape
Regulatory bodies, notably the FDA and EMA, are increasingly supportive of orphan drugs and innovative combinations, offering incentives such as priority review, orphan designations, and accelerated approval programs. The potential for Breakthrough Therapy designation, based on early clinical data, could streamline approval processes, reducing time-to-market and associated costs.

Competitive Environment
The market features several multicomponent regimens, with first-line treatments mainly centered on chemotherapy (e.g., pemetrexed plus cisplatin). Recently, immune checkpoint inhibitors like nivolumab and pembrolizumab have shown promise, positioning immunotherapies as potential differentiators. The IFEX/MESNEX KIT's competitive advantage hinges on demonstrated improved overall survival (OS), manageable safety profile, and patent exclusivity. Companies developing similar combinations or novel agents pose both challenge and opportunity, necessitating strategic intellectual property management.

Pricing and Reimbursement
Pricing strategies for combination therapies in oncology typically reflect their clinical benefit, convenience, and cost-effectiveness. Given the serious prognosis of mesothelioma, payers may favor coverage for innovative kits that provide survival benefits. Reimbursement negotiations will be influenced by health economic assessments, including quality-adjusted life years (QALYs) and cost-utility analyses. Early engagement with payers and health authorities is vital to securing favorable reimbursement terms.

Manufacturing and Supply Chain Considerations
Manufacturing such combination kits demands complex supply chain management, rigorous quality control, and scalable production capabilities. Strategic partnerships with contract manufacturing organizations (CMOs) can mitigate risks associated with supply shortages, regulatory compliance, and cost management. Ensuring consistent quality and reliable supply is critical for commercial success.

Financial Trajectory

Clinical Development Costs and Milestones
The initial phase of development is capital-intensive, primarily driven by clinical trial expenses, regulatory submissions, and manufacturing scale-up. Successfully completing pivotal Phase III trials can cost in the range of $50–$150 million, depending on trial size and geographic scope. Upcoming milestones—such as FDA approval, pivotal trial results, and label expansions—are pivotal points influencing valuation and investment activity.

Revenue Projections
Assuming successful regulatory approval within the next 2–3 years, revenue forecasts for the IFEX/MESNEX KIT can be projected based on epidemiology, pricing strategies, and market penetration assumptions. Conservative estimates suggest peak sales in the range of $500 million to $1 billion annually, driven by first-mover advantage, clinical efficacy, and expanding indications.

Market Penetration and Adoption
Adoption rates are influenced by factors including clinical guidelines updates, oncologist familiarity, and payers' reimbursement decisions. Early adoption is likely to occur within academic and specialty centers, expanding gradually to broader markets. Strategic collaborations with key opinion leaders (KOLs) and participation in treatment guidelines will accelerate uptake.

Investment and Valuation Trends
Venture capital and pharmaceutical investments in oncology combination therapies remain robust, reflecting confidence in their transformative potential. The valuation of companies involved in the development of IFEX/MESNEX KIT will depend on clinical milestones, regulatory advancements, and commercial partnerships. Public offerings and licensing deals could catalyze additional capital influx, sustaining growth trajectories.

Regulatory and Market Risks
Potential hurdles include unforeseen safety concerns, regulatory delays, or failure to demonstrate sufficient clinical benefit. Market risks involve competitive therapies gaining approval or market share faster. Robust early-phase data, strategic IP rights, and diversified indications can mitigate such risks.

Strategic Outlook and Future Opportunities

The trajectory of IFEX/MESNEX KIT underscores a broader shift towards personalized, combination-based oncology treatments. Future opportunities include expanding indications (e.g., other thoracic malignancies), integrating novel immunomodulators, and leveraging biomarker-driven patient stratification to optimize efficacy. Collaborations with biotech firms and academic institutions will augment research and development pipelines, enhancing the firm's ability to adapt to evolving market demands.

Key Takeaways

• The IFEX/MESNEX KIT aims to revolutionize mesothelioma treatment by combining chemotherapeutic and immunotherapeutic agents, addressing high unmet medical needs.
• Regulatory pathways favoring orphan drugs and drug combination approvals can accelerate market entry, boosting financial prospects.
• Market dynamics are shaped by disease prevalence, evolving standards of care, competitive therapies, and reimbursement climate, all pivotal for commercialization.
• Financially, the drug kit presents a high-growth potential, with peak revenues in the mid to high hundreds of millions, contingent upon clinical success and market uptake.
• Stakeholders must navigate significant development costs, regulatory uncertainties, and competitive landscapes, emphasizing the importance of strategic planning and early stakeholder engagement.

FAQs

Q1: What is the current regulatory status of the IFEX/MESNEX KIT?
A: As of the latest data, the kit has received orphan drug designation in key markets like the U.S. and Europe, with ongoing Phase III trials anticipated to support potential approval pathways.

Q2: How does the IFEX/MESNEX KIT compare to existing mesothelioma treatments?
A: It offers a combination approach aiming to improve survival outcomes over standard chemotherapy alone, with early data suggesting enhanced efficacy when integrated with immunotherapy components.

Q3: What factors could impact the financial success of the IFEX/MESNEX KIT?
A: Clinical trial outcomes, regulatory approval timelines, market penetration speed, payer reimbursement decisions, and competitive advancements are critical determinants.

Q4: What are the main risks associated with the commercialization of the IFEX/MESNEX KIT?
A: Potential safety concerns, delays in regulatory review, unanticipated side effects, and aggressive competition from other emerging therapies pose primary risks.

Q5: What future developments could expand the market for this drug kit?
A: Approving additional indications, incorporating novel immunomodulators, and developing companion diagnostics for patient stratification will broaden market potential.

References

1. World Health Organization. Mesothelioma Fact Sheet. (2022).
2. U.S. Food and Drug Administration. Orphan Drug Designations. (2023).
3. GlobalData. Oncology Therapy Market Analysis. (2022).
4. National Cancer Institute. Mesothelioma Treatment Options. (2022).
5. McKinsey & Company. Pharmaceutical Market Trends Report. (2023).