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?
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
|Accord Hlthcare||FLUOROURACIL||fluorouracil||INJECTABLE;INJECTION||040743-002||Apr 26, 2007||AP||RX||No||Yes||► Subscribe||► Subscribe||► Subscribe||► Subscribe|
|Mylan Labs Ltd||FLUOROURACIL||fluorouracil||INJECTABLE;INJECTION||202668-001||Jul 17, 2012||AP||RX||No||No||► Subscribe||► Subscribe||► Subscribe||► Subscribe|
|Gland Pharma Ltd||FLUOROURACIL||fluorouracil||INJECTABLE;INJECTION||210123-001||Oct 27, 2017||AP||RX||No||No||► Subscribe||► Subscribe||► Subscribe||► Subscribe|
|Teva Pharms Usa||FLUOROURACIL||fluorouracil||INJECTABLE;INJECTION||040334-002||Feb 25, 2000||AP||RX||No||Yes||► Subscribe||► Subscribe||► Subscribe||► Subscribe|
|Accord Hlthcare||FLUOROURACIL||fluorouracil||INJECTABLE;INJECTION||040743-001||Apr 26, 2007||AP||RX||No||Yes||► Subscribe||► Subscribe||► Subscribe||► Subscribe|
|Fresenius Kabi Usa||FLUOROURACIL||fluorouracil||INJECTABLE;INJECTION||040291-001||Mar 24, 1999||DISCN||No||No||► Subscribe||► Subscribe||► Subscribe||► Subscribe|
|Valeant Pharms North||CARAC||fluorouracil||CREAM;TOPICAL||020985-001||Oct 27, 2000||AB||RX||Yes||Yes||► Subscribe||► Subscribe||► Subscribe||Y||► Subscribe|
|Teva Pharms Usa||FLUOROURACIL||fluorouracil||INJECTABLE;INJECTION||040333-001||Jan 27, 2000||AP||RX||No||Yes||► Subscribe||► Subscribe||► Subscribe||► Subscribe|
|Fresenius Kabi Usa||FLUOROURACIL||fluorouracil||INJECTABLE;INJECTION||040279-002||Sep 30, 1998||AP||RX||No||Yes||► Subscribe||► Subscribe||► Subscribe||► Subscribe|
|Spectrum Pharms||FLUOROURACIL||fluorouracil||INJECTABLE;INJECTION||012209-001||Approved Prior to Jan 1, 1982||DISCN||Yes||No||► Subscribe||► Subscribe||► Subscribe||► Subscribe|
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Expired Orange Book Patents for Generic Ingredient: fluorouracil
International Patent Family for Ingredient: fluorouracil
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.
Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
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