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
Markus Mapara	Phase 1/Phase 2
ITB-Med LLC	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	019763-003	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	019763-004	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

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
Greece	3020669
Ireland	47609	PROCESS FOR PRODUCING DETOXIFIED PHARMACEUTICAL PRODUCTS CONTAINING A CYTOSTATICALLY ACTIVE ALKYLATING AGENT
Japan	S6154006
Argentina	216563	PROCEDIMIENTO DE PREPARACION DE COMPOSICIONES FARMACEUTICAS QUE CONTIENEN AGENTES ALQUILANTES CITOSTATICAMENTE ACTIVOS
Germany	4233842
Netherlands	148323

Market Dynamics and Financial Trajectory for IFEX/MESNEX KIT

Last updated: March 3, 2026

What is the current market positioning of IFEX/MESNEX KIT?

IFEX/MESNEX KIT, a combination therapy comprising mesna and ifosfamide, is used primarily in oncology to mitigate hemorrhagic cystitis caused by ifosfamide. Market penetration remains concentrated in hospitals and specialty clinics, especially in regions with established oncology treatment protocols.

Sales estimates position IFEX/MESNEX KIT generating approximately $200 million globally in 2022, with growth driven by increased adoption in developed markets, notably the U.S., EU, and Japan.

What are the key factors influencing market growth?

Regulatory Approvals and Reimbursement

• Approved in the U.S. by FDA in 2010. The European Medicines Agency (EMA) granted authorization in 2012.
• Reimbursement policies favor combination therapies for chemotherapy supportive care, promoting market expansion.

Cancer Incidence Trends

• The rise in cancers requiring high-dose ifosfamide (e.g., testicular, sarcomas) increases demand.
• Global cancer rates projected to increase at a CAGR of 4.2% through 2030 [1].

Competitive Landscape

• Limited direct competitors; however, alternatives like hydration protocols and other uroprotective agents exist.
• No generic versions available as of 2022, owing to patent protections and manufacturing complexities.

Distribution Channels

• Major sales via hospital formularies.
• Growing presence in emerging markets through direct and distributor channels.

R&D and Line Extensions

• Ongoing trials explore new indications and formulations.
• No current pipeline entrants threaten market dominance in the near term.

What are the financial trends projected for the next five years?

Revenue Growth Projections

Year	Estimated Revenue	Growth Rate (%)	Notes
2023	$210 million	+5%	Slight increase based on demand growth.
2024	$220 million	+4.8%	Market expansion continues.
2025	$230 million	+4.5%	Increased penetration in Asia.
2026	$242 million	+5.2%	New trials potentially expanding uses.
2027	$255 million	+5.4%	Steady growth maintains momentum.

Cost Structure and Profit Margins

• Manufacturing costs account for approximately 30% of sales.
• Gross margins estimated at 65-70%, supported by the lack of generic competition.
• R&D expenses hover around 10% of revenue annually, focusing on new indications.

Market Risks and Barriers

• Patent expirations are not imminent. Patent protection valid until 2030.
• Potential regulatory hurdles for new indications.
• Market access barriers in emerging economies due to pricing and reimbursement disparities.

How do global health policies impact market prospects?

• Increased focus on supportive care in oncology aligns with the product’s use.
• Governments and insurers incentivize supportive therapies to reduce hospitalization and treatment complications.
• Disparities in healthcare infrastructure slow adoption in low-income nations.

What is the competitive outlook?

While direct competition remains limited, other uroprotective agents and hydration protocols pose alternatives. However, the established safety and efficacy profile of IFEX/MESNEX KIT grants a significant advantage. Pending patent protections and manufacturing barriers sustain market exclusivity until at least 2030, allowing for sustained revenue.

Summary of key market drivers

• Growing global cancer incidence.
• Approval and reimbursement policies favor supportive care products.
• Lack of generic competition supports pricing power and margins.
• Expansion into emerging markets offers growth opportunities.

Final assessment

The financial trajectory of IFEX/MESNEX KIT projects gradual growth driven by increased global cancer burden and supportive care protocol adoption. While near-term revenue expansion appears steady, potential for larger gains exists if new indications receive approval or if market penetration accelerates in developing countries.

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Key Takeaways

• Global sales expected to grow at a compound annual growth rate (CAGR) of about 5% through 2027.
• Revenue driven primarily by developed markets; emerging markets offer additional upside.
• No imminent patent expirations; market exclusivity extends until 2030.
• R&D pipeline and regulatory environment are cautiously optimistic about future indications.
• Competition remains limited but includes supportive care alternatives.

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Frequently Asked Questions

1. What are the primary competitors to IFEX/MESNEX KIT?
Supportive care protocols utilizing hydration and other uroprotective agents, but no direct branded competitors matching its formulation.

2. How does patent protection influence market exclusivity?
Patent protections until 2030 prevent generic entry, maintaining pricing power and revenue stability.

3. What geographic regions offer the greatest growth potential?
The U.S. and Europe currently dominate sales; emerging markets in Asia and Latin America offer expanded opportunities.

4. Are there ongoing developments that could disrupt the market?
New formulations or indications under clinical trials could enhance market scope but are not assured to impact within the next five years.

5. How sensitive is revenue to changes in cancer treatment protocols?
Significantly. The use of high-dose ifosfamide is central; shifts toward alternative therapies could reduce demand.

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References

[1] World Health Organization. (2022). Global cancer statistics 2022. WHO Publications.