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Serving leading biopharmaceutical companies globally:

AstraZeneca
Chinese Patent Office
Federal Trade Commission
Baxter
US Army
Accenture
QuintilesIMS
Mallinckrodt
Fuji
Argus Health

Generated: January 21, 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 patent protection?

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

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
Accord Hlthcare FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040798-001 Apr 26, 2007 AP RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Fresenius Kabi Usa FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040279-002 Sep 30, 1998 AP RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Parenteral ADRUCIL fluorouracil INJECTABLE;INJECTION 081225-001 Aug 28, 1991 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Ebewe Pharma FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040772-001 Aug 11, 2008 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Taro Pharm FLUOROURACIL fluorouracil SOLUTION;TOPICAL 076526-001 Nov 5, 2003 AT RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pharmacia And Upjohn ADRUCIL fluorouracil INJECTABLE;INJECTION 081222-001 Jun 28, 1991 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gland Pharma Ltd FLUOROURACIL fluorouracil INJECTABLE;INJECTION 210123-002 Oct 27, 2017 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Valeant Pharms North CARAC fluorouracil CREAM;TOPICAL 020985-001 Oct 27, 2000 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Accord Hlthcare FLUOROURACIL fluorouracil INJECTABLE;INJECTION 040743-001 Apr 26, 2007 AP RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sandoz FLUOROURACIL fluorouracil INJECTABLE;INJECTION 091299-002 May 2, 2011 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 leading biopharmaceutical companies globally:

Citi
Harvard Business School
AstraZeneca
Cipla
Julphar
US Department of Justice
Merck
Mallinckrodt
QuintilesIMS

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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