EFUDEX Drug Patent Profile
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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. Twenty 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for EFUDEX?
- What are the global sales for EFUDEX?
- What is Average Wholesale Price for EFUDEX?
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: | 3,120 |
| 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 |
| National Cancer Institute (NCI) | N/A |
| UNC Lineberger Comprehensive Cancer Center | N/A |
Pharmacology for EFUDEX
| Drug Class | Nucleoside Metabolic Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bausch | EFUDEX | fluorouracil | SOLUTION;TOPICAL | 016831-001 | Approved Prior to Jan 1, 1982 | AT | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Bausch | EFUDEX | fluorouracil | SOLUTION;TOPICAL | 016831-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
