Last Updated: August 2, 2026

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 Extrovis and is included in one NDA.

The generic ingredient in CARAC is fluorouracil. There are fifteen drug master file entries for this compound. Twenty-two 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 30^th, 1998.

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Summary for CARAC

US Patents:	0
Applicants:	1
NDAs:	1

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Extrovis	CARAC	fluorouracil	CREAM;TOPICAL	020985-001	Oct 27, 2000		RX	Yes	Yes	⤷ 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

International Patents for CARAC

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

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Country	Patent Number	Title	Estimated Expiration
Austria	68965		⤷ Start Trial
Australia	591264		⤷ Start Trial
Australia	7132287		⤷ Start Trial
Germany	3774266		⤷ Start Trial
European Patent Office	0285694	POROUS POLYMERIC BEADS FOR THE DELIVERY OF AN ACTIVE INGREDIENT	⤷ Start Trial
Greece	3003064		⤷ Start Trial
Japan	2680304		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated 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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.