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Last Updated: August 4, 2020

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FLUOROPLEX Drug Profile

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When do Fluoroplex patents expire, and when can generic versions of Fluoroplex launch?

Fluoroplex is a drug marketed by Almirall and Elorac and is included in two NDAs.

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

US ANDA Litigation and Generic Entry Outlook for Fluoroplex

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

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Drug patent expirations by year for FLUOROPLEX
Drug Prices for FLUOROPLEX

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Recent Clinical Trials for FLUOROPLEX

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SponsorPhase
Taizhou Mabtech Pharmaceutical Co.,LtdPhase 3
Bristol-Myers SquibbPhase 1
Stanford UniversityPhase 2

See all FLUOROPLEX clinical trials

Pharmacology for FLUOROPLEX

US Patents and Regulatory Information for FLUOROPLEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Almirall FLUOROPLEX fluorouracil CREAM;TOPICAL 016988-001 Approved Prior to Jan 1, 1982 RX Yes Yes   Start Trial   Start Trial   Start Trial
Elorac FLUOROPLEX fluorouracil SOLUTION;TOPICAL 016765-001 Approved Prior to Jan 1, 1982 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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Serving leading biopharmaceutical companies globally:

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