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. Fifteen 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.
Summary for CARAC
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 214 |
| Patent Applications: | 193 |
| 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 |
Pharmacology for CARAC
| Drug Class | Nucleoside Metabolic Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for CARAC
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 | ⤷ 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
| 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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 0285694 | POROUS POLYMERIC BEADS FOR THE DELIVERY OF AN ACTIVE INGREDIENT | ⤷ Try a Trial |
| Australia | 7132287 | ⤷ Try a Trial | |
| South Africa | 8702665 | ⤷ Try a Trial | |
| Greece | 3003064 | ⤷ Try a Trial | |
| Australia | 591264 | ⤷ Try a 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. 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.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
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