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Serving leading biopharmaceutical companies globally:

US Department of Justice
Farmers Insurance
Daiichi Sankyo
Harvard Business School

Generated: November 21, 2017

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Fomepizole - Generic Drug Details

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What are the generic drug sources for fomepizole and what is the scope of fomepizole freedom to operate?

is the generic ingredient in two branded drugs marketed by Mylan Institutional, Navinta Llc, Luitpold, and Par Pharm Inc, and is included in five NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Fomepizole has nine patent family members in eight countries.

There are five drug master file entries for fomepizole. Four suppliers are listed for this compound.

Pharmacology for fomepizole

Drug ClassAntidote
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Institutional
INJECTABLE;INJECTION079033-001Apr 7, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe
Par Pharm Inc
INJECTABLE;INJECTION020696-001Dec 4, 1997APRXYesYes► Subscribe► SubscribeYY ► Subscribe
Mylan Institutional
INJECTABLE;INJECTION078639-001Mar 3, 2008APRXNoNo► Subscribe► Subscribe► Subscribe
INJECTABLE;INJECTION078368-001Dec 14, 2007APRXNoNo► Subscribe► Subscribe► Subscribe
Navinta Llc
INJECTABLE;INJECTION078537-001Mar 6, 2008APRXNoNo► Subscribe► Subscribe► Subscribe
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International Patent Family for Ingredient: fomepizole

Country Document Number Estimated Expiration
Canada2605413► Subscribe
Mexico2007013118► Subscribe
European Patent Office1948613► Subscribe
World Intellectual Property Organization (WIPO)2006115626► Subscribe
Japan5378788► Subscribe
Japan2008538560► Subscribe
China101163679► Subscribe
South Korea20080000660► Subscribe
Australia2006240490► 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:

Cantor Fitzgerald
Johnson and Johnson
Express Scripts
Fish and Richardson

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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