FLUOROURACIL - Generic Drug Details

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

Fluorouracil is the generic ingredient in six branded drugs marketed by Extrovis, Chartwell Rx, Accord Hlthcare, Dr Reddys Labs Sa, Encube, Taro, Hill Dermaceuticals, Pharmacia And Upjohn, Teva Parenteral, Abic, Abraxis Pharm, Alembic, Bedford, Ebewe Pharma, Eugia Pharma Speclts, Fresenius Kabi Usa, Gland, Kindos, Marchar, Novast Labs, Sagent Pharms Inc, Sandoz, Smith And Nephew, Spectrum Pharms, Teva Pharms Usa, and Elorac, and is included in forty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for fluorouracil. Twenty-one suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for FLUOROURACIL

US Patents:	0
Tradenames:	6
Applicants:	26
NDAs:	49
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	214
Clinical Trials:	2,071
Drug Prices:	Drug price trends for FLUOROURACIL
Drug Sales Revenues:	Drug sales revenues for FLUOROURACIL
What excipients (inactive ingredients) are in FLUOROURACIL?	FLUOROURACIL excipients list
DailyMed Link:	FLUOROURACIL at DailyMed

See drug prices for FLUOROURACIL

See drug sales revenues for FLUOROURACIL

Recent Clinical Trials for FLUOROURACIL

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

Sponsor	Phase
City of Hope Medical Center	PHASE3
Assiut University	NA
M.D. Anderson Cancer Center	PHASE3

See all FLUOROURACIL clinical trials

Generic filers with tentative approvals for FLUOROURACIL

Applicant	Application No.	Strength	Dosage Form
		1GM/20ML (50MG/ML)	INJECTABLE;INJECTION
		500MG/10ML (50MG/ML)	INJECTABLE;INJECTION
		5GM/100ML (50MG/ML)	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for FLUOROURACIL

Drug Class	Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for FLUOROURACIL

Antimetabolites

Antimetabolites, Antineoplastic

Immunosuppressive Agents

Anatomical Therapeutic Chemical (ATC) Classes for FLUOROURACIL

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

Paragraph IV (Patent) Challenges for FLUOROURACIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CARAC	Cream	fluorouracil	0.5%	020985	1	2011-07-29

US Patents and Regulatory Information for FLUOROURACIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kindos	FLUOROURACIL	fluorouracil	INJECTABLE;INJECTION	215699-001	Feb 6, 2025	AP	RX	No	No
Smith And Nephew	FLUOROURACIL	fluorouracil	INJECTABLE;INJECTION	089434-001	Mar 26, 1987		DISCN	No	No
Marchar	FLUOROURACIL	fluorouracil	INJECTABLE;INJECTION	087791-001	Jan 18, 1983		DISCN	No	No
Hill Dermaceuticals	TOLAK	fluorouracil	CREAM;TOPICAL	022259-001	Sep 18, 2015		RX	Yes	Yes
Eugia Pharma Speclts	FLUOROURACIL	fluorouracil	INJECTABLE;INJECTION	202668-002	Jul 17, 2012	AP	RX	No	No
Spectrum Pharms	FLUOROURACIL	fluorouracil	INJECTABLE;INJECTION	087792-001	Oct 13, 1982		DISCN	No	No

Expired US Patents for FLUOROURACIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Extrovis	CARAC	fluorouracil	CREAM;TOPICAL	020985-001	Oct 27, 2000
Extrovis	CARAC	fluorouracil	CREAM;TOPICAL	020985-001	Oct 27, 2000
Hill Dermaceuticals	TOLAK	fluorouracil	CREAM;TOPICAL	022259-001	Sep 18, 2015

Market Dynamics and Financial Trajectory for Fluorouracil

Last updated: February 19, 2026

Fluorouracil (5-FU) is a chemotherapy agent primarily used in the treatment of diverse cancers, including colorectal, breast, stomach, and skin cancers. Its market landscape is shaped by patent status, regulatory developments, emerging alternatives, and global cancer treatment trends.

Regulatory Status and Patent Landscape

Patent Expiry and Generic Competition
The original patents for fluorouracil expired in the early 2000s, leading to widespread availability of generic versions. The absence of patent protection has resulted in increased price competition and accessibility across markets.

Regulatory Approvals and New Formulations
Most regulatory agencies, including the FDA and EMA, have approved multiple formulations—topical (e.g., Efudex), injectable, and combination products. No recent approvals of novel fluorouracil derivatives have been reported in the last five years.

Market Authorization for Biosimilars
No biosimilar versions have been approved specifically for fluorouracil. Ongoing research explores drug delivery innovations rather than chemical modifications.

Market Size and Revenue Streams

Global Market Valuation
The global chemotherapeutic agents market was valued at approximately $17 billion in 2022, with fluorouracil representing a significant segment due to its longstanding use.[1]

Revenue Breakdown by Region

• North America: 45% of global fluorouracil sales, driven by high cancer prevalence, established treatment protocols, and reimbursement policies.
• Europe: 30%, with stable markets but pricing pressures from generics.
• Asia-Pacific: 20%, with growth fueled by increasing cancer incidence and expanding healthcare access.
• Rest of the World: 5%, limited by infrastructure and affordability issues.

Market Trends
Sales revenue for fluorouracil formulations has plateaued in mature markets but remains stable. The drug earns revenue from existing indications without significant recent growth, owing to competition from newer agents and targeted therapies.

Driver and Restraint Factors

Drivers

• Widespread use in standard chemotherapy protocols.
• Cost-effectiveness due to availability of generics.
• Continued approval for multiple indications across cancers.

Restraints

• The emergence of targeted therapies (e.g., monoclonal antibodies like cetuximab) reducing reliance on traditional chemotherapeutics.[2]
• Limitations in efficacy and toxicity concerns associated with fluorouracil.
• Potential shifts towards immuno-oncology treatments.

Competitive Landscape

Leading Pharmaceutical Companies

• Sanofi: Manufactures Efudex (topical formulation).
• Pfizer, Teva, and Sun Pharma: Key producers of generic fluorouracil in injectable forms.
• No dominant patent-holding players due to patent expiry.

Innovative Delivery Systems and Regional Initiatives
Research focuses on nanotechnology, transdermal patches, and combination therapies aiming to improve efficacy and reduce toxicity. These innovations may influence future market dynamics.

Financial Trajectory and Future Outlook

Revenue Trends
Revenue from fluorouracil has shown minor declines in developed markets due to competition from targeted agents but remains steady overall because of its affordability and broad indication base.

Projected Growth

• 2023–2028 compound annual growth rate (CAGR): approximately 2-3% globally, driven by increased cancer incidence in emerging markets.[3]
• No significant uptick anticipated without development of novel formulations or combination therapies.

Potential Catalysts

• Advances in drug delivery could extend the market lifespan.
• Growing cancer burdens in Asia-Pacific may offset declines in mature markets.

Risks and Challenges

• Competition from biologics and immunotherapies reducing fluorouracil’s market share.
• Regulatory shifts favoring personalized medicine approaches.
• Pricing pressures in healthcare systems.

Key Takeaways

• The fluorouracil market operates in a mature phase with sustained demand primarily driven by established indications.
• Patent expiration has led to high generic penetration, capping revenue growth.
• Future growth depends on innovations in delivery systems and combination therapies rather than chemical modifications.
• Emerging markets will sustain demand growth amid aging populations and rising cancer incidences.
• Competition from targeted and immuno-oncology drugs presents ongoing threats to fluorouracil's market share.

FAQs

1. How does patent expiry impact fluorouracil’s market?
Patent expiry has increased generic and biosimilar availability, reducing prices and margins, but expanding access.

2. What are the key competitors to fluorouracil?
Targeted therapies and immunotherapies, such as cetuximab and pembrolizumab, are increasingly used for similar indications.

3. What future innovations could affect fluorouracil’s market?
Nanoparticle delivery systems, transdermal formulations, and combination therapies could rejuvenate interest and extend market viability.

4. Which regions offer the most growth potential for fluorouracil?
Asia-Pacific presents the highest growth opportunities, attributed to rising cancer burdens and improving healthcare infrastructure.

5. Are there any new approvals or formulations in development?
Current research emphasizes improved delivery methods; no new chemical entities or novel approvals for fluorouracil are imminent.

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References

[1] MarketsandMarkets. (2022). Chemotherapeutic Agents Market.
[2] National Institutes of Health. (2021). Targeted Cancer Therapies.
[3] Grand View Research. (2023). Oncology Drugs Market Size and Forecast.
[4] U.S. Food and Drug Administration. (2021). Approved Cancer Medications.