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Last Updated: May 26, 2022

CARAC Drug Patent 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.

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

DrugPatentWatch® 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 Strength NDA ANDAs Submitted Submissiondate
CARAC Cream fluorouracil 0.5% 020985 1 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 CARAC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms North CARAC fluorouracil CREAM;TOPICAL 020985-001 Oct 27, 2000 See Plans and Pricing See Plans and Pricing
Valeant Pharms North CARAC fluorouracil CREAM;TOPICAL 020985-001 Oct 27, 2000 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for CARAC

See the table below for patents covering CARAC around the world.

Country Patent Number Title Estimated Expiration
Germany 3774266 See Plans and Pricing
South Africa 8702665 See Plans and Pricing
European Patent Office 0285694 POROUS POLYMERIC BEADS FOR THE DELIVERY OF AN ACTIVE INGREDIENT See Plans and Pricing
Japan S63256126 MANUFACTURE OF TIME RELEASING DISCHARGE MEDIUM See Plans and Pricing
Austria 68965 See Plans and Pricing
Australia 7132287 See Plans and Pricing
Greece 3003064 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
McKesson
Boehringer Ingelheim
Mallinckrodt
Merck

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