Ifosfamide - Generic Drug Details

What are the generic drug sources for ifosfamide and what is the scope of patent protection?

Ifosfamide is the generic ingredient in four branded drugs marketed by Baxter Hlthcare, Extrovis, Fresenius Kabi Usa, Hikma, Meitheal, and Teva Pharms Usa, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for ifosfamide. Three suppliers are listed for this compound.

Summary for ifosfamide

US Patents:	0
Tradenames:	4
Applicants:	6
NDAs:	7
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	479
Patent Applications:	8,111
Drug Prices:	Drug price trends for ifosfamide
What excipients (inactive ingredients) are in ifosfamide?	ifosfamide excipients list
DailyMed Link:	ifosfamide at DailyMed

See drug prices for ifosfamide

Recent Clinical Trials for ifosfamide

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

Sponsor	Phase
Children's Oncology Group	PHASE2
Swiss Cancer Institute	PHASE2
H. Lee Moffitt Cancer Center and Research Institute	PHASE1

See all ifosfamide clinical trials

Pharmacology for ifosfamide

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for ifosfamide

Antineoplastic Agents, Alkylating

Anatomical Therapeutic Chemical (ATC) Classes for ifosfamide

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

US Patents and Regulatory Information for ifosfamide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	IFOSFAMIDE	ifosfamide	INJECTABLE;INJECTION	090181-001	Sep 22, 2009		DISCN	No	No
Baxter Hlthcare	IFEX	ifosfamide	INJECTABLE;INJECTION	019763-002	Dec 30, 1988	AP	RX	Yes	No
Hikma	IFOSFAMIDE	ifosfamide	INJECTABLE;INJECTION	076619-001	Jun 29, 2011	AP	RX	No	No

Expired US Patents for ifosfamide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare	IFEX	ifosfamide	INJECTABLE;INJECTION	019763-001	Dec 30, 1988	3,732,340
Baxter Hlthcare	IFEX	ifosfamide	INJECTABLE;INJECTION	019763-002	Dec 30, 1988	4,882,452
Baxter Hlthcare	IFEX	ifosfamide	INJECTABLE;INJECTION	019763-002	Dec 30, 1988	3,732,340

Market Dynamics and Financial Trajectory for Ifosfamide

Last updated: July 28, 2025

Introduction

Ifosfamide, a chemotherapeutic agent classified as an alkylating agent, has been a cornerstone in oncology treatments since its FDA approval in 1984. Widely used for various malignancies, including testicular cancer, sarcomas, and lymphomas, its market dynamics are influenced by evolving oncology treatment paradigms, competitive drug landscape, regulatory pathways, and emerging personalized medicine approaches. This report explores the current market environment and project the financial trajectory for ifosfamide within the global pharmaceutical landscape.

Market Overview

Therapeutic Indications and Usage

Ifosfamide’s primary applications are in chemotherapy regimens for:

• Testicular Cancer: especially in combination therapies for refractory cases.
• Soft Tissue Sarcomas: serving as first-line or salvage therapy.
• Lymphomas and other solid tumors: as part of multi-agent chemotherapies.

Its efficacy in these settings remains notable; however, the advent of novel targeted therapies and immunotherapies is redefining treatment standards, impacting demand.

Market Size and Revenue

Globally, the anti-cancer drug market exceeds $150 billion (2022 estimates), with alkylating agents comprising a significant segment. Although specific market size for ifosfamide is not commercially segmented, its sales are influenced by:

• Generic availability: Late entry into patent expiration fosters price competition.
• Off-label use: Expanding or diminishing based on emerging clinical evidence.
• Regional adoption: Higher in regions with established oncology protocols and limited access to newer therapies.

In mature markets like North America and Europe, ifosfamide’s revenue is declining due to competing agents, whereas in emerging markets, its affordability sustains utilization.

Competitive Landscape

The drug faces competition from:

• Other alkylating agents: Melphalan, cyclophosphamide.
• Novel agents: Targeted therapies (e.g., tyrosine kinase inhibitors), immunotherapies (e.g., checkpoint inhibitors) increasingly replacing traditional chemotherapeutics.
• Biosimilars and generics: Intensify price competition, impacting profit margins.

The competitive pressure necessitates innovative positioning strategies to maintain market share.

Market Dynamics Influencing ifosfamide

Regulatory Environment

Regulatory pathways, including abbreviated approval processes for biosimilars and generics, expedite market entry and pricing pressures. Conversely, new formulations or combination therapies incorporating ifosfamide may receive expedited approval, creating niche markets.

Clinical Development and Evidence

Continued clinical research assessing efficacy, safety, and combination regimens influences market sustainability. Recent studies explore reduced dosing, toxicity mitigation, and novel delivery systems, potentially expanding or constraining utilization.

Pricing and Reimbursement

Pricing strategies are shaped by:

• Healthcare policies emphasizing cost-effectiveness.
• Reimbursement frameworks favoring newer, high-cost therapies over older agents like ifosfamide.
• Negotiated discounts and tendering in public health systems.

Price erosion significantly affects profit margins, particularly in commoditized markets.

Emerging Trends and Personalized Medicine

The shift toward precision oncology favors targeted and immunomodulatory agents over broad-spectrum chemotherapies like ifosfamide. This transformation may diminish future demand but could also stimulate niche applications, such as in metastatic or resistant cancers.

Financial Trajectory Analysis

Historical Financial Performance

While exact sales figures are proprietary, industry reports indicate a declining trend post-2010 with the advent of newer therapies. Moderate revenues persist primarily in global markets with limited access to costly innovations.

Forecasted Trends

• Short-term (1–3 years): Continued decline in developed markets due to substitution by targeted agents; marginal growth in low- and middle-income countries.
• Medium-term (4–7 years): Possible stabilization if new formulations or combination protocols enhance clinical utility.
• Long-term (8+ years): Expected further decline unless repositioned within novel treatment regimens or formulations; potential for niche indications.

Impact of Patent and Regulatory Changes

As patents expire or regulatory pathways facilitate generic entry, profit margins may compress further. Conversely, approval of reformulated or combination drugs could generate incremental revenue streams.

Investment and R&D Outlook

Investment in reformulation technologies, such as liposomal or targeted delivery systems, could extend the drug’s lifecycle. Alternatively, investments in companion diagnostics or molecular profiling could reposition ifosfamide as part of personalized protocols.

Strategic Implications

Pharmaceutical companies must weigh:

• The diminishing core market against potential niche opportunities.
• The cost of reformulation versus market expansion.
• The potential for collaborations in combination therapies with emerging modalities.

In addition, markets that prioritize affordability and have limited access to cutting-edge therapies may continue to generate demand, underscoring regional disparities in market dynamics.

Conclusion

The market for ifosfamide faces constrained growth prospects, driven by competition from targeted and immunotherapeutic agents, shifting oncology paradigms, and regulatory pressures. Its financial trajectory is characterized by gradual decline in mature markets, with potential stabilization or modest growth in developing regions. Strategic repositioning via reformulation and integration into personalized medicine approaches could provide new revenue avenues, albeit with required R&D investments.

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Key Takeaways

• Demand Evolution: Moving away from traditional chemotherapeutic agents like ifosfamide toward targeted therapies constrains long-term revenue prospects.
• Market Competition: Generics, biosimilars, and alternative agents intensify price competition, compress margins.
• Regional Variances: Emerging markets sustain demand due to cost considerations, offering growth opportunities.
• Innovation Necessity: Reformulations, combination therapies, and personalized applications are critical for extending the product’s lifecycle.
• Strategic Positioning: Collaborations with biotech firms and focus on niche indications may offset declines in core markets.

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FAQs

1. Will the demand for ifosfamide recover with emerging cancer therapies?
Unlikely. The trend favors targeted and immunotherapies, which are replacing chemotherapeutic agents like ifosfamide in many indications. However, niche uses in resistant or specific tumor types may sustain limited demand.

2. How does patent expiration affect ifosfamide’s market potential?
Patent expirations lead to generic entry, resulting in significant price reductions and reduced profitability for original formulators. This accelerates revenue decline but increases accessibility.

3. Are there ongoing efforts to reformulate or improve the safety profile of ifosfamide?
Yes. Research explores liposomal formulations and combination regimens to reduce toxicity, potentially revitalizing some market segments.

4. What regional factors influence growth for ifosfamide?
In low-resource settings, where cost-efficiency outweighs innovation, demand persists. Regulatory approvals and healthcare infrastructure also impact regional uptake.

5. Could partnership or licensing agreements extend or rejuvenate ifosfamide’s market?
Yes. Collaborations with biotech companies for novel formulations or combination therapies may introduce new revenue streams and broaden application scope.

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References

[1] IQVIA. (2022). Global Oncology Market Report.
[2] European Medicines Agency. (2020). Guidelines on the Use of Chemotherapeutic Agents.
[3] MarketWatch. (2023). Oncology Drug Market Trends.
[4] Investigational New Drugs Journal. (2021). Advances in Alkylating Agent Formulations.
[5] World Health Organization. (2022). Cancer Treatment Accessibility in Low-Resource Settings.