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 Valeant Pharms North, Bausch, Chartwell Rx, Accord Hlthcare, Dr Reddys Labs Sa, Rising, Taro, Hill Dermaceuticals, Pharmacia And Upjohn, Teva Parenteral, Abic, Abraxis Pharm, Alembic, Bedford, Ebewe Pharma, Eugia Pharma Speclts, Fresenius Kabi Usa, Gland Pharma Ltd, Kindos, Marchar, Novast Labs, Sagent Pharms Inc, Sandoz, Smith And Nephew, Spectrum Pharms, Teva Pharms Usa, Elorac, and Encube, and is included in forty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for fluorouracil. Nineteen suppliers are listed for this compound.

Summary for FLUOROURACIL

US Patents:	0
Tradenames:	6
Applicants:	28
NDAs:	47
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	214
Clinical Trials:	1,872
Patent Applications:	7,666
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
Jeeyun Lee	Phase 1/Phase 2
State University of New York - Downstate Medical Center	Phase 1/Phase 2
Harbin Medical University	Phase 2

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
Abraxis Pharm	FLUOROURACIL	fluorouracil	INJECTABLE;INJECTION	089428-001	Jan 12, 1987		DISCN	No	No
Taro	FLUOROURACIL	fluorouracil	SOLUTION;TOPICAL	076526-002	Nov 5, 2003	AT	RX	No	Yes
Abraxis Pharm	FLUOROURACIL	fluorouracil	INJECTABLE;INJECTION	089152-001	Mar 21, 1986		DISCN	No	No
Accord Hlthcare	FLUOROURACIL	fluorouracil	CREAM;TOPICAL	214845-001	Oct 7, 2021	AB	RX	No	No
Alembic	FLUOROURACIL	fluorouracil	INJECTABLE;INJECTION	217295-001	Mar 3, 2023	AP	RX	No	No
Abic	FLUOROURACIL	fluorouracil	INJECTABLE;INJECTION	088929-001	Mar 4, 1986		DISCN	No	No
Novast Labs	FLUOROURACIL	fluorouracil	INJECTABLE;INJECTION	209271-002	Dec 11, 2019		DISCN	No	No

Expired US Patents for FLUOROURACIL

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

FLUOROURACIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluorouracil

Introduction to Fluorouracil

Fluorouracil, a chemotherapeutic agent, is widely used in the treatment of various types of cancer, including colon, esophageal, stomach, breast, and cervical cancers. Understanding the market dynamics and financial trajectory of fluorouracil is crucial for stakeholders in the pharmaceutical industry.

Global Market Size and Growth

The global fluorouracil market is projected to experience steady growth over the forecast period. As of 2023, the market was estimated to be worth approximately $136 million and is forecasted to reach $218.1 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 6.2% from 2024 to 2030[4].

Driving Factors

Several factors drive the growth of the fluorouracil market:

Prevalence of Cancer

The increasing prevalence of cancer globally is a significant driving factor. Cancer is a major health concern, and the demand for effective treatments like fluorouracil continues to rise[1].

Technological Advancements

Vendors in the market are focusing on developing their technological expertise and innovating their product lines. This includes improving production processes for better efficiency and exploring new applications for fluorouracil[1].

Regional Growth

The Asia Pacific region is expected to exhibit the highest growth rate during the forecast period. This is due to the growing awareness and investments in research and development (R&D) in this region[1].

Market Segmentation

The fluorouracil market is segmented based on type and application:

Type

• Injectables
• Capsules
• Tablets

These forms cater to different patient needs and treatment protocols[1].

Application

• Colon Cancer
• Esophageal Cancer
• Stomach Cancer
• Breast Cancer
• Cervical Cancer
• Others

Each application segment has its own demand and growth trajectory, influenced by the prevalence of the respective cancers and the efficacy of fluorouracil in treatment[1].

Competitive Landscape

The global fluorouracil market is highly competitive, with several key players:

• VHB Lifesciences Inc. (Cytocare)
• Cadila Pharmaceuticals Ltd.
• Celon Labs
• Neon Laboratories Ltd
• Samarth Pharma Pvt. Ltd.
• Alkem Laboratories Ltd. (Cytomed)[1]

These companies are investing heavily in R&D and product innovations to maintain and expand their market share.

Geographical Distribution

The market is geographically segmented into:

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa

Each region has its own market dynamics, influenced by local healthcare policies, patient demographics, and economic conditions[1].

Pricing and Cost

The wholesale cost of fluorouracil varies significantly across different regions. In developing regions such as the Asia Pacific, the cost is approximately USD 1.18–3.40 per 500 mg vial. This variability affects the market's financial trajectory and accessibility of the drug[1].

Impact on Related Markets

The growth of the fluorouracil market is closely linked to the broader colorectal cancer drugs market. This market is estimated to grow from $10.23 billion in 2023 to $12.79 billion by 2028, with a CAGR of 4.57%. The increasing efforts to combat colorectal cancer drive the demand for fluorouracil and other related drugs[3].

Future Prospects

The future of the fluorouracil market looks promising due to several factors:

Increasing Cancer Prevalence

The rising incidence of cancer worldwide will continue to drive the demand for fluorouracil.

Innovations and Product Extensions

Continuous innovations and product line extensions by key players will help in maintaining market competitiveness.

Growing Awareness and R&D Investments

Increased awareness and investments in R&D are expected to open up new opportunities for the use of fluorouracil in various cancer treatments[1].

Key Takeaways

• The global fluorouracil market is projected to grow from $136 million in 2023 to $218.1 million by 2030.
• The Asia Pacific region is expected to exhibit the highest growth rate.
• Technological advancements and product innovations are key drivers.
• The market is highly competitive with several major players.
• The wholesale cost varies significantly across different regions.
• The market is closely linked to the broader colorectal cancer drugs market.

FAQs

Q: What is the projected market size of fluorouracil by 2030?

A: The global fluorouracil market is forecasted to reach $218.1 million by 2030[4].

Q: Which region is expected to exhibit the highest growth rate for fluorouracil?

A: The Asia Pacific region is expected to exhibit the highest growth rate during the forecast period[1].

Q: What are the main types of fluorouracil available in the market?

A: The main types include injectables, capsules, and tablets[1].

Q: What are the primary applications of fluorouracil?

A: The primary applications include colon cancer, esophageal cancer, stomach cancer, breast cancer, and cervical cancer[1].

Q: Who are some of the key players in the fluorouracil market?

A: Key players include VHB Lifesciences Inc. (Cytocare), Cadila Pharmaceuticals Ltd., Celon Labs, Neon Laboratories Ltd, and Alkem Laboratories Ltd. (Cytomed)[1].

Sources

1. Reports and Data: Fluorouracil Market Size, Share | Industry Report, 2016-2027
2. JMIR: Characterizing the Anticancer Treatment Trajectory and Pattern in ...
3. GlobeNewswire: Global Colorectal Cancer Drugs Market to Reach USD 12.79 Billion by 2028 with Notable CAGR of 4.57%
4. Valuates Reports: 5-Fluorouracil - Global Market Share and Ranking, Overall Sales ...