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Last Updated: August 8, 2020

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Fluorouracil - Generic Drug Details

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What are the generic drug sources for fluorouracil and what is the scope of patent protection?

Fluorouracil is the generic ingredient in six branded drugs marketed by Valeant Pharms North, Bausch, Almirall, Mayne Pharma, Mylan, Taro, Hill Dermaceuticals, Pharmacia And Upjohn, Teva Parenteral, Abic, Abraxis Pharm, Accord Hlthcare, Bedford, Ebewe Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Ingenus Pharms Llc, Marchar, Mylan Labs Ltd, Sagent Pharms Inc, Sandoz, Smith And Nephew, Spectrum Pharms, Teva Pharms Usa, and Elorac, and is included in forty-two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fluorouracil has three patent family members in three countries.

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

Drug Prices for fluorouracil

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Drug Sales Revenue Trends for fluorouracil

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Recent Clinical Trials for fluorouracil

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

Seattle Genetics, Inc.Phase 1
GlaxoSmithKlinePhase 3
Hutchison Medipharma LimitedPhase 3

See all fluorouracil clinical trials

Pharmacology for fluorouracil
Medical Subject Heading (MeSH) Categories for fluorouracil
Paragraph IV (Patent) Challenges for FLUOROURACIL
Tradename Dosage Ingredient NDA Submissiondate
CARAC CREAM;TOPICAL fluorouracil 020985 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
Abic FLUOROURACIL fluorouracil INJECTABLE;INJECTION 088929-001 Mar 4, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Abraxis Pharm FLUOROURACIL fluorouracil INJECTABLE;INJECTION 089519-001 Mar 12, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Sagent Pharms Inc FLUOROURACIL fluorouracil INJECTABLE;INJECTION 203609-002 Feb 17, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Marchar FLUOROURACIL fluorouracil INJECTABLE;INJECTION 087791-001 Jan 18, 1983 DISCN No No   Start Trial   Start Trial   Start Trial
Teva Parenteral ADRUCIL fluorouracil INJECTABLE;INJECTION 040023-001 Oct 18, 1991 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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