Floxuridine - Generic Drug Details

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

Floxuridine is the generic ingredient in two branded drugs marketed by Am Regent, Fresenius Kabi Usa, Hikma, and Hospira, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for floxuridine

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	57
Patent Applications:	7,548
Drug Prices:	Drug price trends for floxuridine
What excipients (inactive ingredients) are in floxuridine?	floxuridine excipients list
DailyMed Link:	floxuridine at DailyMed

See drug prices for floxuridine

Recent Clinical Trials for floxuridine

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

Sponsor	Phase
UNICANCER	PHASE3
The Netherlands Cancer Institute	PHASE3
Sun Yat-sen University	PHASE2

See all floxuridine clinical trials

Pharmacology for floxuridine

Drug Class

Antimetabolite

Medical Subject Heading (MeSH) Categories for floxuridine

Antimetabolites, Antineoplastic

Anatomical Therapeutic Chemical (ATC) Classes for floxuridine

L01BC	Pyrimidine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for floxuridine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Am Regent	FLOXURIDINE	floxuridine	INJECTABLE;INJECTION	203008-001	Nov 22, 2017		DISCN	No	No
Hikma	FLOXURIDINE	floxuridine	INJECTABLE;INJECTION	075387-001	Apr 16, 2000	AP	RX	No	Yes
Hospira	FUDR	floxuridine	INJECTABLE;INJECTION	016929-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Fresenius Kabi Usa	FLOXURIDINE	floxuridine	INJECTABLE;INJECTION	075837-001	Feb 22, 2001	AP	RX	No	No

Market Dynamics and Financial Trajectory for Floxuridine

Last updated: February 20, 2026

What Is Floxuridine?

Floxuridine (FUdR) is an antimetabolite chemotherapy drug primarily used for the treatment of metastatic colorectal cancer and liver metastases. It inhibits DNA synthesis by mimicking pyrimidine nucleosides, disrupting tumor cell proliferation.

Global Market Size and Growth

The global oncology drugs market was valued at approximately USD 165 billion in 2022. Immunotherapies dominate, but cytotoxic agents like floxuridine retain niche relevance. Precise data on floxuridine's market share is sparse, given its limited approval scope and age.

• Estimated global market for fluoropyrimidines (including fluorouracil and floxuridine) was USD 2.1 billion in 2022.
• Compound annual growth rate (CAGR) from 2023 to 2028 projected at around 5%, driven by expanding indications and regional adoption.

Floxuridine's market is constrained relative to other chemotherapeutic agents due to limited approval statuses, regional usage, and competition from newer targeted therapies.

Market Drivers

• Clinical Efficacy in Specific Cancers: Approved for hepatic artery infusion in colorectal liver metastases, with evidence supporting benefits in localized control.
• Regional Adoption: Primarily utilized in North America, Europe, and select Asian markets where hepatic artery infusion protocols are standard.
• Combination Therapies: Used in combination with other agents, which extend its application but also introduce market competition.

Market Barriers

• Regulatory Limitations: Approved only in select regions; not available in some key markets like China and Japan.
• Competition: Fluorouracil (5-FU) and capecitabine serve as primary alternatives with broader approval and convenience.
• Clinical Preference: Shift toward targeted therapies and immunotherapies reduces reliance on traditional chemotherapy agents like floxuridine.

Patent and Regulatory Landscape

• Floxuridine has been off-patent for decades.
• Limited recent regulatory activity. No major new approvals approved by FDA or EMA since early 2000s.
• Focus shifted to proprietary formulations and delivery mechanisms in niche markets.

Key Regional Insights

Region	Usage	Regulatory Status	Market Potential
North America	Moderate, primarily via infusion	Approved for hepatic metastases by FDA	Steady but niche; growth limited by alternatives
Europe	Similar to North America	Approved for specific indications	Limited expansion; stable niche market
Asia-Pacific	Growing adoption in specific centers	Approved in some countries	Future potential; constrained by local preferences

Financial Trajectory

• Revenue estimates for floxuridine alone are embedded within regional chemotherapy agent sales.
• Incremental growth is expected to be marginal unless new indications emerge.
• Investment in novel delivery systems (e.g., site-specific infusion) could influence future revenues.

Investment Outlook

• Stable but Limited: Floxuridine's role remains niche; large-scale investment unlikely unless new clinical data or formulations emerge.
• Partnerships and Licensing: Potential exists for regional licensing deals, especially where existing protocols favor hepatic infusion therapies.
• Research & Development: R&D efforts focus on combining floxuridine with targeted agents or nanotechnology delivery, which could unlock new markets.

Key Takeaways

• Floxuridine's current market is constrained by existing alternatives and limited approvals.
• Growth prospects hinge on new indications, formulations, or delivery mechanisms.
• Regional adoption, especially in hepatic-directed therapies, sustains niche revenues.
• Competitive landscape shifts favor targeted therapies over traditional chemotherapies.
• Major pharmaceutical firms show minimal activity around floxuridine, emphasizing its niche status.

FAQs

1. Why has floxuridine seen limited recent regulatory activity?
Because it has been off-patent for decades, and alternative agents with broader indications and easier oral administration have taken precedence.

2. Which indications currently drive floxuridine sales?
Primarily hepatic artery infusion for colorectal liver metastases, where it forms part of regional chemotherapy protocols.

3. How does floxuridine compare to fluorouracil (5-FU)?
Floxuridine is used mainly in regional infusion settings, while 5-FU is administered systemically and has broader approval for multiple cancer types.

4. Are there new formulations or delivery methods under development?
Some research targets nanocarrier systems for optimized delivery, which could extend its use but remains in early stages.

5. Which regions hold the most promise for future floxuridine use?
Asia-Pacific and emerging markets where regional hepatic therapies are gaining adoption.

References

[1] MarketWatch. (2023). Oncology drugs market size, trends, and forecasts.
[2] GlobalData. (2023). Chemotherapy agents market analysis.
[3] U.S. Food and Drug Administration. (2000). FDA approval database.
[4] European Medicines Agency. (2022). Summary of medicinal product characteristics for floxuridine.
[5] International Agency for Research on Cancer. (2022). Global cancer statistics.