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Last Updated: July 29, 2021

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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, 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, Marchar, Mylan Labs Ltd, Novast Labs, 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. Fourteen suppliers are listed for this compound.

Drug Prices for FLUOROURACIL

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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

SponsorPhase
Institut du Cancer de Montpellier - Val d'AurellePhase 2/Phase 3
Shanghai Junshi Bioscience Co., Ltd.Phase 2/Phase 3
Thomas Jefferson UniversityPhase 1/Phase 2

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
Mylan FLUOROURACIL fluorouracil CREAM;TOPICAL 203122-001 Apr 20, 2015 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Hill Dermaceuticals TOLAK fluorouracil CREAM;TOPICAL 022259-001 Sep 18, 2015 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Bausch EFUDEX fluorouracil CREAM;TOPICAL 016831-003 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Gland Pharma Ltd FLUOROURACIL fluorouracil INJECTABLE;INJECTION 210124-001 Dec 26, 2017 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan Labs Ltd FLUOROURACIL fluorouracil INJECTABLE;INJECTION 202669-002 Jul 17, 2012 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Abraxis Pharm FLUOROURACIL fluorouracil INJECTABLE;INJECTION 089428-001 Jan 12, 1987 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Novast Labs FLUOROURACIL fluorouracil INJECTABLE;INJECTION 209271-002 Dec 11, 2019 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms North CARAC fluorouracil CREAM;TOPICAL 020985-001 Oct 27, 2000 ⤷  Try it Free ⤷  Try it Free
Valeant Pharms North CARAC fluorouracil CREAM;TOPICAL 020985-001 Oct 27, 2000 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Merck
Medtronic
Express Scripts
Moodys

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