FLUOROURACIL - Generic Drug Details

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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. Twenty 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:	20
Raw Ingredient (Bulk) Api Vendors:	214
Clinical Trials:	1,872
Patent Applications:	7,714
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

Drug Sales Revenue Trends 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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gland Pharma Ltd	FLUOROURACIL	fluorouracil	INJECTABLE;INJECTION	210124-002	Dec 26, 2017	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	FLUOROURACIL	fluorouracil	INJECTABLE;INJECTION	040334-002	Feb 25, 2000		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sagent Pharms Inc	FLUOROURACIL	fluorouracil	INJECTABLE;INJECTION	203608-001	May 11, 2017	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ebewe Pharma	FLUOROURACIL	fluorouracil	INJECTABLE;INJECTION	040772-001	Aug 11, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Encube	FLUOROURACIL	fluorouracil	SOLUTION;TOPICAL	215612-001	Nov 2, 2023	AT	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for FLUOROURACIL

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

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