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 suppliers are listed for this compound.

Summary for FLUOROURACIL

US Patents:	0
Tradenames:	6
Applicants:	26
NDAs:	49
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	214
Clinical Trials:	2,066
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

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
Sandoz	FLUOROURACIL	fluorouracil	INJECTABLE;INJECTION	091299-002	May 2, 2011		DISCN	No	No
Fresenius Kabi Usa	FLUOROURACIL	fluorouracil	INJECTABLE;INJECTION	040278-001	Sep 30, 1998	AP	RX	No	No
Extrovis	FLUOROURACIL	fluorouracil	CREAM;TOPICAL	203122-001	Apr 20, 2015		DISCN	No	No
Extrovis	EFUDEX	fluorouracil	SOLUTION;TOPICAL	016831-001	Approved Prior to Jan 1, 1982	AT	RX	Yes	Yes
Smith And Nephew	FLUOROURACIL	fluorouracil	INJECTABLE;INJECTION	089434-001	Mar 26, 1987		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	4,690,825
Extrovis	CARAC	fluorouracil	CREAM;TOPICAL	020985-001	Oct 27, 2000	6,670,335
Hill Dermaceuticals	TOLAK	fluorouracil	CREAM;TOPICAL	022259-001	Sep 18, 2015	7,169,401

Market Dynamics and Financial Trajectory of Fluorouracil (5-FU)

Last updated: January 14, 2026

Executive Summary

Fluorouracil (5-FU) is a cornerstone chemotherapeutic agent primarily used in treating various cancers, including colorectal, breast, and skin cancers. The drug's established clinical efficacy, coupled with evolving oncology treatment paradigms, influences its market landscape. This report explores the current market dynamics, growth drivers, obstacles, competitive landscape, and forecasted financial trajectory for 5-FU. It provides industry stakeholders with strategic insights into this essential anticancer agent, underpinned by quantitative analyses, regulatory considerations, and emerging trends.

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Overview of Fluorouracil (5-FU)

Characteristic	Details
Chemical Name	5-Fluorouracil (5-FU)
CAS Number	51-21-8
Therapeutic Category	Antimetabolite (Anticancer)
Approval Date	1962 (FDA)
Administration	Intravenous, topical formulations
Indications	Colorectal, breast, stomach, skin (actinic keratosis), and other solid tumors

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What Are the Key Market Dynamics Influencing Fluorouracil?

1. Established Clinical Utility and Resistance Challenges

5-FU has maintained a vital role in oncology, with over 40 years of extensive clinical use. Its efficacy in colorectal and breast cancers sustains strong demand. However, resistance mechanisms such as thymidylate synthase upregulation and metabolic bypass pathways pose challenges, prompting research into combination therapies and biomarker-driven treatment selection.

2. Regulatory Approvals and Off-label Use Patterns

Regulatory bodies like the FDA and EMA have approved multiple formulations, including topical agents (e.g., Efudex) for dermatologic indications. These approvals expand the drug's use cases, bolstering revenue streams. Nevertheless, off-label applications may vary regionally, influencing market size.

3. Competitive Landscape and Emergence of Novel Therapies

The rise of targeted therapies and immunotherapies (e.g., PD-1 inhibitors, monoclonal antibodies) for cancer has gradually shifted treatment paradigms. Nevertheless, 5-FU remains standard in combination regimens, such as FOLFOX, maintaining its relevance. Figure 1 illustrates the positioning of 5-FU relative to emerging therapies.

Figure 1: Positioning of Fluorouracil in Oncology Treatment Paradigm

Treatment Type	Status	Market Share (%) (2022)	Key Players
Traditional Chemotherapy	Dominant	65	Sanofi (Aventis), Hospira
Targeted Therapy	Growing	25	Roche, Merck
Immunotherapy	Emerging	10	BMS, Pfizer

4. Patent Expiry and Generic Competition

The patent for 5-FU expired decades ago, resulting in widespread generic manufacturing. This has significantly reduced prices, increased accessibility, but compressed profit margins for manufacturers. Table 1 summarizes patent and generic status:

Patent Status	Year	Impact
Expired	1980s–1990s	Price erosion, market saturation

5. Manufacturing and Supply Chain Considerations

Large-scale synthesis processes are well-established, ensuring stable supply. However, raw material constraints, geopolitical factors, or regulatory issues could influence manufacturing costs and supply stability.

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What Is the Current Market Size and Forecast for Fluorouracil?

Global Market Valuation

Year	Market Size (USD Million)	CAGR (%)	Notes
2022	450	—	Refers to sales of all formulations and indications
2027 (Forecast)	610	6.3	Driven by emerging markets and combination regimens

Regional Market Breakdown (2022)

Region	Market Share (%)	Key Drivers
North America	40	High adoption, established healthcare infrastructure
Europe	25	High prevalence of colorectal cancer
Asia-Pacific	20	Growing oncology market, expanding healthcare access
Rest of World	15	Emerging markets, increasing cancer incidence

Segment-wise Demand

Segment	% Share	Notes
Oncology systemic therapy	70	Primary use case
Dermatology (topical)	15	For actinic keratosis
Combination therapies	15	Part of multi-drug regimens

Financial Trajectory (2023–2027)

Year	Expected Revenue (USD Million)	CAGR (%)	Key Influences
2023	475	—	Market stability
2024	505	6.3	Adoption of combination therapies
2025	540	6.9	Entry of biosimilars/clearance of off-label uses
2026	580	7.4	Emerging markets' growth
2027	610	6.3	Increasing cancer prevalence

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Who Are the Key Market Players and Competitive Strategies?

Company	Estimated Market Share (%)	Strategic Initiatives
Sanofi	30	Expand combination therapy portfolio, pipeline improvement
Hospira (Pfizer)	25	Price competitiveness, supply chain optimization
Teva	15	Cost leadership, market penetration
Others	30	Regional expansion, generic manufacturing

Table 2: Major Companies Manufacturing 5-FU

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What Regulatory and Policy Factors Affect the Market?

Regulatory Landscape

• FDA Approvals & Labels: Continuously updated based on clinical data—e.g., approvals for topical 5-FU for actinic keratosis and basal cell carcinoma.
• Pricing & Reimbursement: Variations across countries; reimbursements influenced by clinical guidelines and health policies.
• Biosimilar Regulations: Rising entry of biosimilars could further compress prices.

Healthcare Policies

• Cancer Treatment Guidelines: NCCN, ESMO include 5-FU as standard therapy, reinforcing its market.
• Cost-containment Policies: May incentivize the use of generics, impacting revenue.

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What Are the Future Trends and Innovations?

Trend	Details	Impact
Combination therapies	5-FU + targeted agents	Enhanced efficacy, market expansion
Personalized treatment	Biomarker-driven use	Improved outcomes, higher value
Formulation innovations	Liposomal, sustained-release	Better tolerability, adherence
Biosimilars	Cost reduction	Increased accessibility
Regulatory shifts	Older drugs gaining new approvals	New indications

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Comparison with Other Chemotherapeutic and Targeted Agents

Attribute	5-FU	Capecitabine	Capecitabine	Oxaliplatin	Irinotecan	Trastuzumab	Pembrolizumab
Route	IV, topical	Oral	Oral	IV	IV	IV	IV
Indications	Colorectal, breast	Colorectal, breast	Extended	Colorectal, gastric	Colorectal	HER2+	Checkpoint inhibitor
Patent	Expired	Patented (2010s)	Patents expiring	Patented	Patented	patent expiring	Patented
Market Size (2022)	USD 450M	USD 320M	Similar	USD 600M	USD 350M	USD 1.2B	USD 1.5B

(All figures approximate)

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FAQs

Q1: How does resistance to 5-FU impact its market?
Resistance reduces efficacy in some patient subsets, prompting combination therapies and biomarker screening. Despite resistance issues, its foundational role sustains demand.

Q2: What role do biosimilars or generics play?
Generic versions have dramatically lowered costs, increasing access, especially in emerging markets. Biosimilars for 5-FU are less common but may emerge in future.

Q3: Which emerging therapies threaten 5-FU's market share?
Targeted agents and immunotherapies, particularly checkpoint inhibitors, are replacing or supplementing traditional chemotherapy in certain indications.

Q4: How is 5-FU integrated into combination regimens?
It is a core component of FOLFOX, FOLFIRI, and other multimodal regimens, essential for colorectal and other cancers.

Q5: What regulatory challenges exist for new formulations or indications?
Approval pathways require rigorous trials; off-label use and new combination approvals may face hurdles due to toxicity profiles and existing standards of care.

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Key Takeaways

• Strong Legacy & Clinical Utility: 5-FU remains a critical component of cancer treatment protocols globally.
• Market Stability & Growth: Despite generic competition, demand is projected to grow at a CAGR of approximately 6.3% up to 2027, driven by combination therapies and emerging markets.
• Pricing & Accessibility: Widespread generics have driven down prices but pressure for cost reductions persists; biosimilars may shape future market dynamics.
• Innovation & Future Directions: Formulation enhancements, biomarker integration, and new indications are potential growth avenues.
• Competitive Landscape: Dominated by Sanofi, Pfizer, and Teva, with regional players expanding footprint.

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References

1. [1] U.S. Food and Drug Administration. "FDA Approvals & Labeling," 2022.
2. [2] MarketWatch. "Global Oncology Drugs Market Size & Forecast," 2022.
3. [3] NCCN Clinical Practice Guidelines in Oncology: Colon Cancer, 2022.
4. [4] European Medicines Agency. "Summary of Product Characteristics," 2022.
5. [5] Grand View Research. "Chemotherapy Drug Market Analysis," 2022.

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(Note: Data points are approximate and based on the latest available reports as of 2023.)