IFOSFAMIDE Drug Patent Profile

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When do Ifosfamide patents expire, and what generic alternatives are available?

Ifosfamide is a drug marketed by Extrovis, Fresenius Kabi Usa, Hikma, Meitheal, and Teva Pharms Usa. and is included in six NDAs.

The generic ingredient in IFOSFAMIDE is ifosfamide; mesna. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ifosfamide; mesna profile page.

Summary for IFOSFAMIDE

US Patents:	0
Applicants:	5
NDAs:	6
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	482
Patent Applications:	4,725
Drug Prices:	Drug price information 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
USWM, LLC (dba US WorldMeds)	PHASE2
Milton S. Hershey Medical Center	PHASE2
Second Affiliated Hospital, School of Medicine, Zhejiang University	PHASE2

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
Extrovis	IFOSFAMIDE	ifosfamide	INJECTABLE;INJECTION	201689-001	Nov 26, 2012		DISCN	No	No
Hikma	IFOSFAMIDE	ifosfamide	INJECTABLE;INJECTION	076619-001	Jun 29, 2011	AP	RX	No	No
Fresenius Kabi Usa	IFOSFAMIDE	ifosfamide	INJECTABLE;INJECTION	090181-001	Sep 22, 2009		DISCN	No	No

Ifosfamide Market Dynamics, Patent Status, Financial Trajectory, and Generic Competition

Last updated: November 3, 2026

Ifosfamide is an established generic alkylating agent used mainly in combination regimens for sarcomas, testicular cancer, lymphomas, and other solid tumors. Its branded exclusivity has expired, no biosimilar pathway applies, and competition is driven by injectable generic supply, hospital purchasing, manufacturing capacity, and shortage risk rather than patent protection. Drug-level revenue is not publicly reported with precision because sales are distributed across multiple generic suppliers and institutional contracts.

What is the current market position of ifosfamide?

Ifosfamide is an intravenous cytotoxic chemotherapy drug and a prodrug of the active metabolite isophosphoramide mustard. It is usually administered with mesna and vigorous hydration because of its urotoxicity and risks of encephalopathy, myelosuppression, nephrotoxicity, and gonadal toxicity.[1]

The U.S. product is commonly supplied as an injectable powder for solution in 1-gram and 3-gram vials, with dosing determined by the treatment protocol and body-surface area. Its most established uses include:

Market attribute	Ifosfamide position
Drug class	Oxazaphosphorine alkylating agent
Main route	Intravenous infusion
Primary settings	Hospital and specialized oncology centers
Major uses	Soft-tissue sarcoma, testicular cancer, lymphoma and selected solid tumors
Administration	Usually multi-day or high-dose combination therapy
Required supportive therapy	Mesna, hydration, antiemetics and laboratory monitoring
Regulatory status	FDA-approved prescription oncology drug
Product type	Small-molecule generic injectable
Biosimilar exposure	None
Current commercial model	Institutional procurement and generic contracting

Ifosfamide is not a high-volume retail prescription product. It is purchased by hospitals, cancer centers, group purchasing organizations, wholesalers, and government health systems. Demand is therefore tied to chemotherapy protocols, oncology admissions, inventory policies, and supplier reliability.

How large is the ifosfamide market?

Public market reports often place the global ifosfamide market in the low hundreds of millions of dollars, but estimates vary substantially by whether they include active pharmaceutical ingredient sales, finished-dose injectables, hospital procurement, and combination-treatment revenue. These reports are not equivalent to audited manufacturer sales.

A more defensible commercial conclusion is that ifosfamide is a mature, low-growth oncology market with concentrated value in the injectable finished-dose segment. Its market is materially smaller than markets for newer targeted therapies, checkpoint inhibitors, antibody-drug conjugates, and oral oncology products.

What drives ifosfamide demand?

Demand is supported by four factors:

1. Continued use in sarcoma and testicular cancer treatment protocols.
2. Limited substitution in selected salvage and combination regimens.
3. Use in tertiary hospitals that maintain cytotoxic chemotherapy inventories.
4. Low unit prices that support broad formulary access.

Demand is constrained by:

• availability of newer regimens;
• toxicity concerns;
• complex administration requirements;
• the need for mesna and hydration;
• declining use of older cytotoxic agents in some disease settings;
• hospital efforts to reduce inpatient chemotherapy exposure.

The drug has protocol importance without having substantial pricing power. Hospitals can often switch among approved suppliers, but they cannot always replace ifosfamide with a therapeutically equivalent drug for every indication.

What is the financial trajectory for ifosfamide?

Ifosfamide has the financial profile of a mature generic oncology injectable.

Historical trajectory

The commercial trajectory generally follows four stages:

Period	Financial characteristic
Branded period	Higher pricing and greater manufacturer control
Generic entry	Rapid price erosion and supplier expansion
Mature generic period	Low unit prices, institutional contracting and thin margins
Current market	Stable clinical demand with episodic supply-driven price increases

The branded Ifex product lost commercial importance after generic competition. Generic entry shifted value away from brand pricing and toward manufacturing scale, regulatory reliability, and hospital contracts.

Revenue exposure

No single manufacturer publicly reports a separately audited global revenue line for ifosfamide in the way that public companies report major branded products. The commercial value is fragmented across:

• finished-dose injectable manufacturers;
• contract manufacturers;
• distributors and wholesalers;
• hospital purchasing organizations;
• international government tenders;
• active pharmaceutical ingredient suppliers.

For a manufacturer, ifosfamide revenue is typically portfolio revenue rather than a standalone growth driver. The drug can still be strategically valuable because it occupies oncology formulary space and can be bundled with other injectable products.

Margin outlook

Margins are pressured by:

• multiple approved generic suppliers;
• hospital tendering;
• group purchasing contracts;
• limited differentiation among injectable presentations;
• costly cytotoxic handling requirements;
• quality-control and containment requirements;
• raw-material and sterile-manufacturing risks.

Margins can improve temporarily during shortages or supplier exits. Those improvements are usually supply-driven rather than patent-driven and may reverse when capacity returns.

When does ifosfamide lose exclusivity?

Ifosfamide has already lost branded and regulatory exclusivity in the United States. The active ingredient is an old small molecule, and generic versions have been marketed for years.

FDA exclusivity and patent rights are separate. Any historical compound, formulation, or use patents associated with the original branded product have expired or no longer prevent ordinary generic competition. The practical market is therefore post-exclusivity.

What is the Orange Book status of ifosfamide?

The FDA Orange Book is the controlling source for current listed patents and exclusivity entries.[2] Ifosfamide is not commercially protected by a current branded patent estate that blocks generic injectable competition.

Historically, Ifex was associated with an FDA-approved injectable product. Current commercial supply is primarily represented by generic products rather than a protected branded franchise. Orange Book entries can change as products are discontinued, transferred, or delisted, so the relevant assessment is the current listing for the specific NDA and dosage form.

IP category	Current commercial effect
Active ingredient patents	No meaningful barrier to generic supply
Original product patents	Expired or commercially irrelevant
FDA exclusivity	Expired
Formulation patents	No known active estate that materially restricts standard generic injection
Method-of-use patents	No current estate that broadly prevents established oncology use
Manufacturing patents	Potential process value, but not a market-wide barrier
Trade secrets	May affect yield, impurity control and cost, not generic legality

How many patents cover ifosfamide?

The number of historical patent documents associated with ifosfamide is not the same as the number of enforceable patents that affect current U.S. competition. The active ingredient and established injectable use are long past their principal patent terms.

A current competitive analysis should distinguish:

1. expired composition-of-matter patents;
2. expired process patents;
3. formulation patents that may have covered particular presentations;
4. use patents limited to specific dosing or combinations;
5. patents covering manufacturing improvements rather than the drug itself.

No active patent category appears to provide broad exclusivity for conventional ifosfamide injection in the U.S. market. Patent risk is therefore low relative to regulatory, supply-chain, and quality risks.

What formulations are protected by ifosfamide patents?

The commercially relevant formulation is a sterile injectable powder that is reconstituted before intravenous administration. This formulation is operationally demanding but not commercially protected by a meaningful current exclusivity position.

Potential technical differentiation can include:

• vial size;
• reconstitution time;
• stability after dilution;
• storage conditions;
• impurity profile;
• container-closure configuration;
• manufacturing yield;
• compatibility with infusion systems.

These factors may support procurement preferences or manufacturing economics. They generally do not create durable market exclusivity without an active patent and meaningful clinical or regulatory differentiation.

What is the FDA regulatory status of ifosfamide?

Ifosfamide is FDA approved as an injectable prescription chemotherapy product. The FDA-approved label identifies its use in combination chemotherapy for selected malignancies, including germ-cell testicular cancer regimens.[1]

The regulatory burden remains significant despite generic status. Manufacturers must demonstrate compliance with:

• sterile injectable manufacturing standards;
• current good manufacturing practice requirements;
• cytotoxic containment and worker-safety controls;
• validated analytical methods;
• stability specifications;
• extractables and leachables controls;
• container-closure integrity;
• labeling and medication-error controls.

The drug's toxicity profile also increases pharmacovigilance and medication-management requirements. Mesna is generally used to reduce urothelial toxicity, while renal, neurologic, hematologic, and hepatic monitoring remains important.

Are there Paragraph IV challenges for ifosfamide?

Paragraph IV litigation is not a major current market issue for ifosfamide. The drug is already subject to long-standing generic competition, and the central patent barriers associated with the original branded product have expired.

For an old generic injectable, ANDA litigation risk is generally replaced by:

• manufacturing site inspection risk;
• ANDA deficiency risk;
• sterile-product contamination risk;
• shortage-related enforcement scrutiny;
• supplier withdrawal;
• changes in reference-listed-drug status;
• hospital conversion risk.

A new entrant would normally compete against established approved products rather than challenge a commercially powerful active patent estate.

Which companies are challenging or competing with the originator?

The originator is no longer the central competitive force. The relevant competitors are generic injectable manufacturers and distributors. Market participation can vary by country and procurement cycle, but the competitive set has included major generic and hospital-injectable suppliers such as Hikma, Fresenius Kabi, Pfizer’s Hospira business, and other regional manufacturers and distributors, subject to current product listings and supply status.

Competition is assessed at the product level rather than solely by corporate ownership because:

• a manufacturer may supply through a distributor;
• a product may be discontinued while the company remains active in oncology;
• supply may be limited to certain vial sizes;
• U.S. approval does not establish global availability;
• hospital contracts can change the visible supplier mix.

What generic entry risks exist for ifosfamide?

Generic entry risk is high in the legal sense because no broad active patent barrier is evident. Commercial entry risk is more complex.

Risks to incumbent suppliers

Incumbents face:

• price competition;
• contract loss to lower-cost suppliers;
• substitution after temporary shortages resolve;
• wholesaler inventory pressure;
• regulatory action at a manufacturing site;
• raw-material disruptions;
• low-volume product discontinuation.

Risks to new entrants

New entrants face:

• high sterile manufacturing costs;
• hazardous-drug containment requirements;
• limited pricing upside;
• difficult hospital contracting;
• need for reliable supply over multiple purchasing cycles;
• regulatory scrutiny of injectable quality;
• inventory and expiry risk.

A new entrant may obtain approval but still fail to secure meaningful share if it cannot offer dependable supply, competitive pricing, and established distribution.

What patent litigation affects ifosfamide?

No major current patent litigation appears to control U.S. ifosfamide competition. Historical disputes may have involved generic approval, labeling, or product rights, but those matters do not create a current market-wide exclusivity barrier.

The most material disputes for a mature injectable product are more likely to involve:

• ANDA quality or approval issues;
• product liability;
• manufacturing defects;
• contamination events;
• supply contracts;
• hospital purchasing agreements;
• reimbursement and substitution practices.

These matters can affect revenue without changing the underlying patent position.

Are there biosimilar risks for ifosfamide?

No. Ifosfamide is a chemically synthesized small molecule, not a biologic. Biosimilar regulation under the Public Health Service Act does not apply.

Competitive substitution occurs through ordinary generic-drug pathways under the Federal Food, Drug, and Cosmetic Act. The principal commercial risk comes from additional generic injectable suppliers, not biosimilar entrants.

What licensing deals affect ifosfamide?

Ifosfamide is not associated with a prominent current licensing transaction that drives its market economics. Historical commercialization arrangements may have involved product rights, distribution, or regional supply, but the mature generic market is mainly governed by manufacturing and procurement agreements.

Potential transaction value is more likely to arise from:

• acquisition of an injectable oncology portfolio;
• contract manufacturing;
• regional distribution rights;
• hospital supply contracts;
• API sourcing;
• bundled generic-product agreements.

A standalone ifosfamide license would generally have limited strategic value unless tied to broader sterile oncology capacity or an exclusive regional tender.

How does ifosfamide compare with competing chemotherapy drugs?

Ifosfamide competes clinically with other alkylating agents and regimen alternatives, but substitution depends on tumor type and treatment line.

Drug or class	Competitive relationship
Cyclophosphamide	Broader use and usually lower-cost alternative in many regimens
Dacarbazine	Used in some sarcoma and lymphoma settings
Etoposide combinations	Important in testicular cancer and other tumor protocols
Cisplatin combinations	Central competitor in germ-cell cancer regimens
Temozolomide	Oral alternative in selected indications, not a direct replacement
Doxorubicin	Common sarcoma comparator and combination partner
New targeted agents	May displace older chemotherapy in biomarker-defined populations

Ifosfamide retains value where clinicians need its specific activity, especially in sarcoma and salvage treatment. Its use is less defensible where lower-toxicity or more convenient alternatives provide comparable outcomes.

What manufacturing and geographic barriers affect ifosfamide?

Geographic availability is uneven. In the U.S., Europe, Japan, and other regulated markets, access depends on approved sterile facilities and national procurement systems. In lower-income markets, supply may depend on tenders, local registration, and imported finished product or API.

The main manufacturing barriers are:

• handling of a hazardous cytotoxic compound;
• sterile powder filling;
• containment and operator protection;
• validated reconstitution and stability data;
• reliable vial supply;
• compliance with inspection requirements;
• economic viability at low generic prices.

Regional supply concentration creates shortage exposure. If one or more manufacturers withdraw, hospitals may experience allocation or delayed delivery even though the underlying drug is off patent.

What is the outlook for ifosfamide revenue and market growth?

The base case is stable-to-declining unit demand with episodic price volatility. Revenue growth is unlikely to come from premium pricing or patent-protected innovation.

The strongest commercial opportunities are:

• dependable supply during competitor shortages;
• expansion into underpenetrated regional markets;
• bundled hospital portfolios;
• efficient sterile manufacturing;
• differentiated packaging or logistics;
• contract manufacturing for oncology suppliers.

The principal downside risks are declining use in favor of newer therapies, supplier consolidation, reduced inpatient chemotherapy, and persistent price pressure.

Key Takeaways

• Ifosfamide is a mature, off-patent injectable oncology drug.
• Its commercial value is concentrated in hospital and cancer-center procurement.
• No biosimilar pathway applies because the drug is a small molecule.
• Current patent litigation and Paragraph IV risk are limited.
• Formulation and manufacturing know-how may affect cost and supply, but do not create broad market exclusivity.
• Revenue is fragmented across generic manufacturers and is not generally disclosed as a standalone public-company metric.
• The main investment variables are sterile manufacturing reliability, hospital contracting, shortage exposure, and demand from sarcoma and testicular cancer protocols.
• The market outlook is stable to declining in volume, with temporary pricing upside during supply disruptions.

FAQs

Does ifosfamide still have patent protection?

No broad active patent protection appears to prevent generic injectable competition in the United States. Historical patents associated with the original product are expired or commercially ineffective.

Is ifosfamide a generic drug?

Yes. Ifosfamide is supplied primarily as a generic intravenous injectable. The former Ifex brand no longer determines market pricing.

Can hospitals substitute generic ifosfamide products automatically?

Substitution depends on FDA product ratings, state law, hospital pharmacy policy, procurement contracts, and the specific presentation. Hospital use also depends on vial size, availability, and formulary status.

Why can an off-patent ifosfamide product experience shortages?

Sterile cytotoxic manufacturing has high compliance and containment costs. A plant shutdown, quality investigation, raw-material disruption, or supplier withdrawal can reduce supply even when several products are nominally approved.

Is mesna part of the ifosfamide product?

Mesna is a separate supportive-care drug commonly administered with ifosfamide. It is not the same active ingredient and is not generally included in the ifosfamide vial.

References

1. U.S. Food and Drug Administration. (n.d.). Ifosfamide injection prescribing information. DailyMed. https://dailymed.nlm.nih.gov/
2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/
3. National Cancer Institute. (n.d.). Ifosfamide. National Cancer Institute Drug Dictionary. https://www.cancer.gov/publications/dictionaries/cancer-drug/def/ifosfamide
4. U.S. Food and Drug Administration. (n.d.). Generic drug products and abbreviated new drug applications. https://www.fda.gov/drugs/generic-drugs
5. U.S. Food and Drug Administration. (n.d.). Drug shortages. https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages