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FLUOROURACIL Drug Profile
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» See Plans and PricingWhich patents cover Fluorouracil, and when can generic versions of Fluorouracil launch?
Fluorouracil is a drug marketed by Mayne Pharma, Mylan, Taro, Abic, Abraxis Pharm, Accord Hlthcare, Bedford, Ebewe Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Ingenus Pharms Llc, Marchar, Mylan Labs Ltd, Sagent Pharms Inc, Sandoz, Smith And Nephew, Spectrum Pharms, and Teva Pharms Usa. and is included in thirty-three NDAs.
The generic ingredient in FLUOROURACIL is fluorouracil. There are fifteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the fluorouracil profile page.
US ANDA Litigation and Generic Entry Outlook for Fluorouracil
A generic version of FLUOROURACIL was approved as fluorouracil by FRESENIUS KABI USA on September 30th, 1998.
Summary for FLUOROURACIL
See drug prices for FLUOROURACIL
Pharmacology for FLUOROURACIL
| Drug Class | Nucleoside Metabolic Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for FLUOROURACIL
Paragraph IV (Patent) Challenges for FLUOROURACIL
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CARAC | CREAM;TOPICAL | fluorouracil | 020985 | 2011-07-29 |
US Patents and Regulatory Information for FLUOROURACIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Smith And Nephew | FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 089434-001 | Mar 26, 1987 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Mylan Labs Ltd | FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 202668-001 | Jul 17, 2012 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Taro | FLUOROURACIL | fluorouracil | SOLUTION;TOPICAL | 076526-002 | Nov 5, 2003 | AT | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| Teva Pharms Usa | FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 040334-001 | Feb 25, 2000 | AP | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| Marchar | FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 087791-001 | Jan 18, 1983 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
