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, Mylan, Taro, Abic, Abraxis Pharm, Alembic, Bedford, Ebewe Pharma, Eugia Pharma Speclts, Fresenius Kabi Usa, Gland Pharma Ltd, Marchar, Novast Labs, Sagent Pharms Inc, Sandoz, Smith And Nephew, Spectrum Pharms, Teva Pharms Usa, and Encube. and is included in thirty-seven NDAs.
The generic ingredient in FLUOROURACIL 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 Fluorouracil
A generic version of FLUOROURACIL was approved as fluorouracil by FRESENIUS KABI USA on September 30th, 1998.
Summary for FLUOROURACIL
US Patents: | 0 |
Applicants: | 20 |
NDAs: | 37 |
Finished Product Suppliers / Packagers: | 14 |
Raw Ingredient (Bulk) Api Vendors: | 214 |
Clinical Trials: | 1,837 |
Patent Applications: | 193 |
Formulation / Manufacturing: | see details |
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 |
Recent Clinical Trials for FLUOROURACIL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Arcus Biosciences, Inc. | Phase 1 |
Assiut University | Early Phase 1 |
Akeso | Phase 1/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 | 091299-002 | May 2, 2011 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Novast Labs | FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 209219-002 | Dec 12, 2019 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Teva Pharms Usa | FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 040334-002 | Feb 25, 2000 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Spectrum Pharms | FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 012209-002 | Jul 29, 2016 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Teva Pharms Usa | FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 040333-001 | Jan 27, 2000 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Gland Pharma Ltd | FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 210124-001 | Dec 26, 2017 | AP | RX | 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 |