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Last Updated: March 19, 2024

Fluorouracil - Generic Drug Details


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

There are fifteen drug master file entries for fluorouracil. Seventeen 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

SponsorPhase
Arcus Biosciences, Inc.Phase 1
Assiut UniversityEarly Phase 1
AkesoPhase 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 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
Encube FLUOROURACIL fluorouracil SOLUTION;TOPICAL 215612-001 Nov 2, 2023 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novast Labs FLUOROURACIL fluorouracil INJECTABLE;INJECTION 209219-002 Dec 12, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma Speclts FLUOROURACIL fluorouracil INJECTABLE;INJECTION 202668-001 Jul 17, 2012 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 a Trial ⤷  Try a Trial
Valeant Pharms North CARAC fluorouracil CREAM;TOPICAL 020985-001 Oct 27, 2000 ⤷  Try a Trial ⤷  Try a Trial
Hill Dermaceuticals TOLAK fluorouracil CREAM;TOPICAL 022259-001 Sep 18, 2015 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.