EFUDEX Drug Patent Profile
✉ Email this page to a colleague
When do Efudex patents expire, and when can generic versions of Efudex launch?
Efudex is a drug marketed by Bausch and is included in one NDA.
The generic ingredient in EFUDEX 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 Efudex
A generic version of EFUDEX was approved as fluorouracil by FRESENIUS KABI USA on September 30th, 1998.
Summary for EFUDEX
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 216 |
Clinical Trials: | 74 |
Patent Applications: | 193 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for EFUDEX |
What excipients (inactive ingredients) are in EFUDEX? | EFUDEX excipients list |
DailyMed Link: | EFUDEX at DailyMed |
Recent Clinical Trials for EFUDEX
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 |
Pharmacology for EFUDEX
Drug Class | Nucleoside Metabolic Inhibitor |
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for EFUDEX
US Patents and Regulatory Information for EFUDEX
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bausch | EFUDEX | fluorouracil | CREAM;TOPICAL | 016831-003 | Approved Prior to Jan 1, 1982 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Bausch | EFUDEX | fluorouracil | SOLUTION;TOPICAL | 016831-001 | Approved Prior to Jan 1, 1982 | AT | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Bausch | EFUDEX | fluorouracil | SOLUTION;TOPICAL | 016831-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | 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 |