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Last Updated: March 19, 2024

FLUOROURACIL Drug Patent Profile


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Which patents cover Fluorouracil, and when can generic versions of Fluorouracil launch?

Fluorouracil is a drug marketed by Accord Hlthcare, Dr Reddys Labs Sa, Mylan, Taro, 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, and Encube. and is included in thirty-seven NDAs.

The generic ingredient in FLUOROURACIL is fluorouracil. There are fifteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fluorouracil

A generic version of FLUOROURACIL was approved as fluorouracil by FRESENIUS KABI USA on September 30th, 1998.

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Drug patent expirations by year for FLUOROURACIL
Drug Prices for FLUOROURACIL

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Drug Sales Revenue Trends for FLUOROURACIL

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Recent Clinical Trials for FLUOROURACIL

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SponsorPhase
Arcus Biosciences, Inc.Phase 1
Assiut UniversityEarly Phase 1
AkesoPhase 1/Phase 2

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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
Sandoz FLUOROURACIL fluorouracil INJECTABLE;INJECTION 091299-002 May 2, 2011 DISCN 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
Teva Pharms Usa FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040334-002 Feb 25, 2000 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Spectrum Pharms FLUOROURACIL fluorouracil INJECTABLE;INJECTION 012209-002 Jul 29, 2016 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040333-001 Jan 27, 2000 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gland Pharma Ltd FLUOROURACIL fluorouracil INJECTABLE;INJECTION 210124-001 Dec 26, 2017 AP RX 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

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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.