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Fluorouracil - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for fluorouracil?

Fluorouracil is the generic ingredient in six branded drugs marketed by Bedford, Sagent Pharms, Spectrum Pharms, Abraxis Pharm, Spear Pharms Inc, Pharmacia And Upjohn, Teva Parenteral, Spear Pharms, Taro, Abic, Valeant Pharm Intl, Teva Pharms Usa, Smith And Nephew, Accord Hlthcare, Hill Dermaceuticals, Elorac, Mylan Labs Ltd, Ebewe Pharma, Fresenius Kabi Usa, Valeant Pharms North, Aqua Pharms, Marchar, and Sandoz, and is included in thirty-seven NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has three patent family members in three countries.

There are fifteen drug master file entries for fluorouracil. Nineteen suppliers are listed for this compound.

Summary for Generic Name: fluorouracil

Tradenames:6
Patents:3
Applicants:23
NDAs:37
Drug Master File Entries: see list15
Suppliers / Packagers: see list19
Bulk Api Vendors: see list124
Clinical Trials: see list538
Patent Applications: see list169
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:fluorouracil at DailyMed

Pharmacology for Ingredient: fluorouracil

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Spear Pharms Inc
FLUOROURACIL
fluorouracil
CREAM;TOPICAL203122-001Apr 20, 2015RXNoNo► Subscribe► Subscribe
Spectrum Pharms
FLUOROURACIL
fluorouracil
INJECTABLE;INJECTION087792-001Oct 13, 1982DISCNNoNo► Subscribe► Subscribe
Valeant Pharm Intl
EFUDEX
fluorouracil
SOLUTION;TOPICAL016831-002Approved Prior to Jan 1, 1982RXYesYes► Subscribe► Subscribe
Abic
FLUOROURACIL
fluorouracil
INJECTABLE;INJECTION088929-001Mar 4, 1986DISCNNoNo► Subscribe► Subscribe
Taro
FLUOROURACIL
fluorouracil
CREAM;TOPICAL090368-001Mar 5, 2010RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: fluorouracil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharms North
CARAC
fluorouracil
CREAM;TOPICAL020985-001Oct 27, 20004,690,825► Subscribe
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International Patent Family for Ingredient: fluorouracil

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2005009406► Subscribe
Canada2541373► Subscribe
European Patent Office1696868► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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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