FLUOROPLEX Drug Patent Profile
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When do Fluoroplex patents expire, and when can generic versions of Fluoroplex launch?
Fluoroplex is a drug marketed by Chartwell Rx and Elorac and is included in two NDAs.
The generic ingredient in FLUOROPLEX is fluorouracil. There are fifteen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Fluoroplex
A generic version of FLUOROPLEX was approved as fluorouracil by FRESENIUS KABI USA on September 30th, 1998.
Summary for FLUOROPLEX
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 216 |
Clinical Trials: | 21 |
Patent Applications: | 193 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for FLUOROPLEX |
What excipients (inactive ingredients) are in FLUOROPLEX? | FLUOROPLEX excipients list |
DailyMed Link: | FLUOROPLEX at DailyMed |
Recent Clinical Trials for FLUOROPLEX
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Chicago | Phase 1 |
UNC Lineberger Comprehensive Cancer Center | N/A |
National Cancer Institute (NCI) | N/A |
Anatomical Therapeutic Chemical (ATC) Classes for FLUOROPLEX
US Patents and Regulatory Information for FLUOROPLEX
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Chartwell Rx | FLUOROPLEX | fluorouracil | CREAM;TOPICAL | 016988-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Elorac | FLUOROPLEX | fluorouracil | SOLUTION;TOPICAL | 016765-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ 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 |