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Last Updated: August 4, 2020

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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

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

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:

Johnson and Johnson
Express Scripts

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.