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BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

Cipla
Medtronic
Queensland Health
QuintilesIMS
Teva
Julphar
US Department of Justice
Farmers Insurance
US Army
AstraZeneca

Generated: November 19, 2017

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Fluorouracil - Generic Drug Details

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What are the generic sources for fluorouracil and what is the scope of fluorouracil patent protection?

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

Fluorouracil has three patent family members in three countries.

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

Pharmacology for fluorouracil

Medical Subject Heading (MeSH) Categories for fluorouracil

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare
FLUOROURACIL
fluorouracil
INJECTABLE;INJECTION040798-001Apr 26, 2007APRXNoYes► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
FLUOROURACIL
fluorouracil
INJECTABLE;INJECTION040333-001Jan 27, 2000APRXNoYes► Subscribe► Subscribe► Subscribe
Sandoz
FLUOROURACIL
fluorouracil
INJECTABLE;INJECTION091299-001May 2, 2011DISCNNoNo► Subscribe► Subscribe► Subscribe
Spear Pharms
FLUOROURACIL
fluorouracil
CREAM;TOPICAL077524-001Apr 11, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Sagent Pharms
FLUOROURACIL
fluorouracil
INJECTABLE;INJECTION203609-001Feb 17, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
FLUOROURACIL
fluorouracil
INJECTABLE;INJECTION040279-001Sep 30, 1998APRXNoYes► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
FLUOROURACIL
fluorouracil
INJECTABLE;INJECTION040379-001Nov 15, 2000DISCNNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
FLUOROURACIL
fluorouracil
INJECTABLE;INJECTION040278-002Sep 30, 1998APRXNoYes► Subscribe► Subscribe► Subscribe
Valeant Pharm Intl
EFUDEX
fluorouracil
CREAM;TOPICAL016831-003Approved Prior to Jan 1, 1982ABRXYesYes► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
FLUOROURACIL
fluorouracil
INJECTABLE;INJECTION040334-002Feb 25, 2000APRXNoYes► Subscribe► 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, 2000► Subscribe► Subscribe
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International Patent Family for Ingredient: fluorouracil

Country Document Number Estimated Expiration
European Patent Office1696868► Subscribe
Canada2541373► Subscribe
World Intellectual Property Organization (WIPO)2005009406► 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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Serving leading biopharmaceutical companies globally:

Cipla
Baxter
Healthtrust
Novartis
US Department of Justice
Queensland Health
Chubb
Merck
Fish and Richardson
Citi

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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