FLUOROURACIL - Generic Drug Details
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What are the generic sources for fluorouracil and what is the scope of freedom to operate?
Fluorouracil
is the generic ingredient in six branded drugs marketed by Valeant Pharms North, Bausch, Chartwell Rx, Accord Hlthcare, Dr Reddys Labs Sa, Rising, Taro, Hill Dermaceuticals, Pharmacia And Upjohn, Teva Parenteral, 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, Elorac, and Encube, and is included in forty-seven NDAs. Additional information is available in the individual branded drug profile pages.There are fifteen drug master file entries for fluorouracil. Twenty suppliers are listed for this compound.
Summary for FLUOROURACIL
| US Patents: | 0 |
| Tradenames: | 6 |
| Applicants: | 28 |
| NDAs: | 47 |
| Drug Master File Entries: | 15 |
| Finished Product Suppliers / Packagers: | 20 |
| Raw Ingredient (Bulk) Api Vendors: | 214 |
| Clinical Trials: | 1,872 |
| Patent Applications: | 7,714 |
| Drug Prices: | Drug price trends 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 |
|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pharmacia And Upjohn | ADRUCIL | fluorouracil | INJECTABLE;INJECTION | 017959-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novast Labs | FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 209271-001 | Dec 11, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novast Labs | FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 209271-002 | Dec 11, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Spectrum Pharms | FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 012209-002 | Jul 29, 2016 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pharmacia And Upjohn | ADRUCIL | fluorouracil | INJECTABLE;INJECTION | 081222-001 | Jun 28, 1991 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sagent Pharms Inc | FLUOROURACIL | fluorouracil | INJECTABLE;INJECTION | 203608-001 | May 11, 2017 | AP | RX | 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 |
Expired US Patents for FLUOROURACIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Valeant Pharms North | CARAC | fluorouracil | CREAM;TOPICAL | 020985-001 | Oct 27, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Hill Dermaceuticals | TOLAK | fluorouracil | CREAM;TOPICAL | 022259-001 | Sep 18, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Valeant Pharms North | CARAC | fluorouracil | CREAM;TOPICAL | 020985-001 | Oct 27, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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