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Last Updated: March 4, 2021

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CARAC Drug Profile

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When do Carac patents expire, and what generic alternatives are available?

Carac is a drug marketed by Valeant Pharms North and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

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

US ANDA Litigation and Generic Entry Outlook for Carac

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

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Paragraph IV (Patent) Challenges for CARAC
Tradename Dosage Ingredient NDA Submissiondate
CARAC CREAM;TOPICAL fluorouracil 020985 2011-07-29

US Patents and Regulatory Information for CARAC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms North CARAC fluorouracil CREAM;TOPICAL 020985-001 Oct 27, 2000 RX Yes Yes   Start Trial   Start Trial Y   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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Merck

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