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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Healthtrust
Deloitte
Chubb
Novartis
Fuji
Moodys
Cipla
Farmers Insurance
Teva

Generated: February 17, 2018

DrugPatentWatch Database Preview

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 forty 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

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
Mylan Labs Ltd FLUOROURACIL fluorouracil INJECTABLE;INJECTION 202668-002 Jul 17, 2012 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gland Pharma Ltd FLUOROURACIL fluorouracil INJECTABLE;INJECTION 210123-002 Oct 27, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Valeant Pharm Intl EFUDEX fluorouracil SOLUTION;TOPICAL 016831-002 Approved Prior to Jan 1, 1982 AT RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hill Dermaceuticals TOLAK fluorouracil CREAM;TOPICAL 022259-001 Sep 18, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sandoz FLUOROURACIL fluorouracil INJECTABLE;INJECTION 091299-001 May 2, 2011 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Taro Pharm FLUOROURACIL fluorouracil SOLUTION;TOPICAL 076526-002 Nov 5, 2003 AT RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Valeant Pharm Intl EFUDEX fluorouracil SOLUTION;TOPICAL 016831-001 Approved Prior to Jan 1, 1982 AT RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040278-001 Sep 30, 1998 AP RX No Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Spectrum Pharms FLUOROURACIL fluorouracil INJECTABLE;INJECTION 087792-001 Oct 13, 1982 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Labs Ltd FLUOROURACIL fluorouracil INJECTABLE;INJECTION 202668-001 Jul 17, 2012 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

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Teva
Boehringer Ingelheim
QuintilesIMS
Chinese Patent Office
Merck
Covington
Queensland Health
Julphar

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