IFOSFAMIDE; MESNA - Generic Drug Details

What are the generic drug sources for ifosfamide; mesna and what is the scope of freedom to operate?

Ifosfamide; mesna is the generic ingredient in two branded drugs marketed by Baxter Hlthcare and Teva Pharms Usa, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for IFOSFAMIDE; MESNA

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Clinical Trials:	482
DailyMed Link:	IFOSFAMIDE; MESNA at DailyMed

Recent Clinical Trials for IFOSFAMIDE; MESNA

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

Sponsor	Phase
Milton S. Hershey Medical Center	PHASE2
USWM, LLC (dba US WorldMeds)	PHASE2
Second Affiliated Hospital, School of Medicine, Zhejiang University	PHASE2

See all IFOSFAMIDE; MESNA clinical trials

Pharmacology for IFOSFAMIDE; MESNA

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Anatomical Therapeutic Chemical (ATC) Classes for IFOSFAMIDE; MESNA

L01AA	Nitrogen mustard analogues
L01A	ALKYLATING AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

R05CB	Mucolytics
R05C	EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

V03AF	Detoxifying agents for antineoplastic treatment
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for IFOSFAMIDE; MESNA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa	IFOSFAMIDE/MESNA KIT	ifosfamide; mesna	INJECTABLE;INTRAVENOUS	075874-001	Feb 26, 2002		DISCN	No	No
Baxter Hlthcare	IFEX/MESNEX KIT	ifosfamide; mesna	INJECTABLE;INJECTION	019763-004	Oct 10, 1992		DISCN	No	No
Teva Pharms Usa	IFOSFAMIDE/MESNA KIT	ifosfamide; mesna	INJECTABLE;INTRAVENOUS	075874-002	Feb 26, 2002		DISCN	No	No
Baxter Hlthcare	IFEX/MESNEX KIT	ifosfamide; mesna	INJECTABLE;INJECTION	019763-003	Oct 10, 1992		DISCN	No	No

Expired US Patents for IFOSFAMIDE; MESNA

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

IFOSFAMIDE; MESNA Market Analysis and Financial Projection

Last updated: February 14, 2026

What Are the Current Market Dynamics for Ifosfamide and Mesna?

The market for ifosfamide and mesna is driven by their roles in chemotherapy regimens, primarily for cancer treatment. As of 2023, the demand for these drugs remains stable, sustained by ongoing cancer prevalence and treatment protocols.

Market Size and Revenue

• The global oncology drug market reached approximately $220 billion in 2022, with alkylating agents like ifosfamide accounting for an estimated 8-10% of this segment.
• The use of mesna, which is administered to mitigate hemorrhagic cystitis caused by ifosfamide, has seen growth paralleling the rise in alkylating agent usage.

Key Market Drivers

• Increasing incidence of cancers such as testicular, ovarian, and soft tissue sarcomas, which utilize ifosfamide.
• Expansion of combination chemotherapy protocols that incorporate ifosfamide.
• Growing awareness and use of mesna for toxicity management, boosting demand for supportive care drugs.

Market Challenges

• Limited patent protection for generic formulations constrains pricing power.
• Side-effect profile of ifosfamide, including neurotoxicity and hemorrhagic cystitis, necessitates supportive care with mesna, impacting overall treatment costs.
• Regulatory pressures emphasizing safety and efficacy standards influence market access.

Competitive Landscape

• Major pharmaceutical manufacturers include Baxter International (marketed as Uromitexan for mesna), Pfizer, and Sagent Pharmaceuticals.
• Generics dominate the market due to patent expirations, such as that of Uromitexan in 2018.

Regional Variations

• North America and Europe represent the largest markets, with high adoption rates for combination therapy.
• Asian markets exhibit growth potential, driven by increasing cancer prevalence and expanding healthcare infrastructure.

What Is the Financial Trajectory for Ifosfamide and Mesna?

Revenue Trends

• Global sales of ifosfamide are estimated between $150 million and $250 million annually, primarily driven by generic sales.
• Mesna's annual sales are roughly $120 million to $150 million, with demand closely tied to ifosfamide use.

Pricing Dynamics

• Generic versions have reduced prices by 60-80% since patent expirations.
• Price per vial ranges from $10 to $50, depending on the formulation and region.

Profitability Outlook

• Margins are generally low due to high competition in generics.
• Manufacturers that maintain supply chain efficiency and secure long-term distribution agreements tend to outperform.

R&D and Regulatory Considerations

• Limited R&D investment is observed, as existing formulations are mature.
• Ongoing regulatory updates on safety standards could increase costs or limit market access for some formulations.

Market Outlook (Next 5 Years)

• Compound annual growth rate (CAGR) estimated at 2-4%, reflecting market saturation in developed countries.
• Emerging markets could see higher growth rates (up to 6-8%), fueled by rising cancer rates and infrastructure development.
• The shift toward targeted therapies may restrict the growth of traditional alkylating agents over the longer term.

How Do Market Drivers and Challenges Affect Future Financial Outcomes?

• The removal of patent protections may keep revenue growth modest.
• Increased adoption of combination therapies, however, sustains demand for supportive agents like mesna.
• Cost pressures and regulatory changes could compress profit margins further.
• Growth in emerging markets, coupled with increasing cancer incidence, offers upside potential.

What Are the Key Drivers for Market Expansion or Contraction?

Drivers:

• Rising global cancer burden.
• Expansion of chemotherapy protocols incorporating ifosfamide.
• Implementation of supportive care with mesna.

Constraints:

• Competition from newer agents and targeted therapies.
• Regulatory tightening on safety standards.
• Pricing pressures from governments and insurance payers.

Key Takeaways

• The market for ifosfamide and mesna remains stable with slow growth, primarily driven by cancer prevalence.
• Generic sales dominate, constraining profitability but ensuring widespread availability.
• Growth is projected in emerging markets, driven by increased healthcare access and cancer treatment needs.
• Regulatory and safety standards may influence future pricing and formulary decisions.
• Specialty and combination therapies may gradually reduce demand for traditional alkylating agents in mature markets.

FAQs

1. What factors influence the pricing of generic ifosfamide and mesna?
Pricing depends on manufacturing costs, regional regulations, competitive landscape, and volume. Generic drugs typically sell at 60-80% lower than branded counterparts.

2. Are there any upcoming regulatory changes affecting these drugs?
Regulatory agencies are emphasizing safety profiles and optimal supportive care use, which could influence approved indications and manufacturing standards.

3. How is the demand for mesna expected to evolve?
Demand will track ifosfamide use, with growth driven by increased chemotherapy protocols and the need for toxicity management.

4. Who are the primary competitors in this market?
Baxter International (Uromitexan), Pfizer, and Sagent Pharmaceuticals are key players, especially in the generic segment.

5. What is the long-term outlook for these drugs?
They will likely experience slow growth amid rising cancer cases, with risk of decline as targeted therapies replace traditional alkylating agents in some indications.

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Sources

[1] MarketWatch, "Global Oncology Drugs Market," 2022
[2] IQVIA, "Global Oncology Supportive Care Market Analysis," 2023
[3] U.S. FDA, "Regulatory Status of Alkylating Agents," 2022
[4] Pfizer annual report, 2022
[5] Baxter International investor presentations, 2022