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. Nineteen 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
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	216
Patent Applications:	3,126
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CARAC
What excipients (inactive ingredients) are in CARAC?	CARAC excipients list
DailyMed Link:	CARAC at DailyMed

Drug patent expirations by year for CARAC

Pharmacology for CARAC

Drug Class	Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for CARAC

L01BC	Pyrimidine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
Valeant Pharms North	CARAC	fluorouracil	CREAM;TOPICAL	020985-001	Oct 27, 2000		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharms North	CARAC	fluorouracil	CREAM;TOPICAL	020985-001	Oct 27, 2000	⤷ Try a Trial	⤷ Try a Trial
Valeant Pharms North	CARAC	fluorouracil	CREAM;TOPICAL	020985-001	Oct 27, 2000	⤷ Try a Trial	⤷ Try a Trial
>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.

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Country	Patent Number	Title	Estimated Expiration
Spain	2025570		⤷ Try a Trial
Japan	2680304		⤷ Try a Trial
Japan	S63256126	MANUFACTURE OF TIME RELEASING DISCHARGE MEDIUM	⤷ Try a Trial
Austria	68965		⤷ Try a Trial
Greece	3003064		⤷ Try a Trial
Australia	7132287		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Summary for CARAC

Pharmacology for CARAC

Anatomical Therapeutic Chemical (ATC) Classes for CARAC

Paragraph IV (Patent) Challenges for CARAC

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