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Serving leading biopharmaceutical companies globally:

Cerilliant
Accenture
Covington
UBS
Chubb
Cipla
Chinese Patent Office
Federal Trade Commission
Farmers Insurance
Teva

Generated: December 11, 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 freedom to operate?

Fluorouracil
is the generic ingredient in six branded drugs marketed by Valeant Pharms North, Valeant Pharm Intl, Aqua Pharms, Mylan Pharms Inc, Spear Pharms, Taro, Hill Dermaceuticals, Pharmacia And Upjohn, Teva Parenteral, Abic, Abraxis Pharm, Accord Hlthcare, Bedford, Ebewe Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Marchar, Mylan Labs Ltd, Sagent Pharms, Sandoz, Smith And Nephew, Spectrum Pharms, Teva Pharms Usa, Elorac, and Taro Pharm, and is included in thirty-nine 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. Nineteen 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 Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Accord HlthcareFLUOROURACILfluorouracilINJECTABLE;INJECTION040743-002Apr 26, 2007APRXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Labs LtdFLUOROURACILfluorouracilINJECTABLE;INJECTION202668-001Jul 17, 2012APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Gland Pharma LtdFLUOROURACILfluorouracilINJECTABLE;INJECTION210123-001Oct 27, 2017APRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Teva Pharms UsaFLUOROURACILfluorouracilINJECTABLE;INJECTION040334-002Feb 25, 2000APRXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Accord HlthcareFLUOROURACILfluorouracilINJECTABLE;INJECTION040743-001Apr 26, 2007APRXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaFLUOROURACILfluorouracilINJECTABLE;INJECTION040291-001Mar 24, 1999DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Valeant Pharms NorthCARACfluorouracilCREAM;TOPICAL020985-001Oct 27, 2000ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Teva Pharms UsaFLUOROURACILfluorouracilINJECTABLE;INJECTION040333-001Jan 27, 2000APRXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Fresenius Kabi UsaFLUOROURACILfluorouracilINJECTABLE;INJECTION040279-002Sep 30, 1998APRXNoYes► Subscribe► Subscribe► Subscribe► Subscribe
Spectrum PharmsFLUOROURACILfluorouracilINJECTABLE;INJECTION012209-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► 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 NorthCARACfluorouracilCREAM;TOPICAL020985-001Oct 27, 2000► Subscribe► 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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Serving leading biopharmaceutical companies globally:

Fuji
Teva
Moodys
Chubb
Medtronic
Federal Trade Commission
Mallinckrodt
Chinese Patent Office
QuintilesIMS
Express Scripts

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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