FLUOROURACIL Drug Patent Profile
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Which patents cover Fluorouracil, and when can generic versions of Fluorouracil launch?
Fluorouracil is a drug marketed by Accord Hlthcare, Dr Reddys Labs Sa, Rising, Taro, Abic, Abraxis Pharm, Alembic, Bedford, Ebewe Pharma, Eugia Pharma Speclts, Fresenius Kabi Usa, Gland Pharma Ltd, Kindos, Marchar, Novast Labs, Sagent Pharms Inc, Sandoz, Smith And Nephew, Spectrum Pharms, Teva Pharms Usa, and Encube. and is included in thirty-eight NDAs.
The generic ingredient in FLUOROURACIL 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 Fluorouracil
A generic version of FLUOROURACIL 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 FLUOROURACIL?
- What are the global sales for FLUOROURACIL?
- What is Average Wholesale Price for FLUOROURACIL?
Summary for FLUOROURACIL
| US Patents: | 0 |
| Applicants: | 21 |
| NDAs: | 38 |
| Finished Product Suppliers / Packagers: | 17 |
| Raw Ingredient (Bulk) Api Vendors: | 214 |
| Clinical Trials: | 1,872 |
| Patent Applications: | 3,126 |
| Drug Prices: | Drug price information for FLUOROURACIL |
| Drug Sales Revenues: | Drug sales revenues for FLUOROURACIL |
| What excipients (inactive ingredients) are in FLUOROURACIL? | FLUOROURACIL excipients list |
| DailyMed Link: | FLUOROURACIL at DailyMed |
See drug prices for FLUOROURACIL
Recent Clinical Trials for FLUOROURACIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Jeeyun Lee | Phase 1/Phase 2 |
| State University of New York - Downstate Medical Center | Phase 1/Phase 2 |
| Harbin Medical University | Phase 2 |
Pharmacology for FLUOROURACIL
| Drug Class | Nucleoside Metabolic Inhibitor |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for FLUOROURACIL
Anatomical Therapeutic Chemical (ATC) Classes for FLUOROURACIL
Paragraph IV (Patent) Challenges for FLUOROURACIL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| CARAC | Cream | fluorouracil | 0.5% | 020985 | 1 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz | FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 091299-001 | May 2, 2011 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Marchar | FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 087791-001 | Jan 18, 1983 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva Pharms Usa | FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 040334-001 | Feb 25, 2000 | DISCN | No | 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 |
