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Choline fenofibrate - Generic Drug Details

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Choline fenofibrate is the generic ingredient in two branded drugs marketed by Mylan Pharms Inc, Actavis Elizabeth, Abbvie, Lupin Ltd, Impax Labs Inc, and Anchen Pharms, and is included in six NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has nineteen patent family members in eleven countries.

There are ninety-nine drug master file entries for choline fenofibrate. Nine suppliers are listed for this compound.

Summary for Generic Name: choline fenofibrate

Drug Master File Entries: see list99
Suppliers / Packagers: see list9
Clinical Trials: see list78
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:choline fenofibrate at DailyMed

Pharmacology for Ingredient: choline fenofibrate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Impax Labs Inc
choline fenofibrate
CAPSULE, DELAYED RELEASE;ORAL200264-001Sep 7, 2016RXNoNo► subscribe► subscribe
choline fenofibrate
CAPSULE, DELAYED RELEASE;ORAL022224-002Dec 15, 2008RXYesYes7,259,186► subscribeY ► subscribe
Actavis Elizabeth
choline fenofibrate
CAPSULE, DELAYED RELEASE;ORAL200920-001Oct 7, 2015RXNoNo► subscribe► subscribe
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International Patent Family for Ingredient: choline fenofibrate

Country Document Number Estimated Expiration
Russian Federation2008149770► subscribe
Russian Federation2005122439► subscribe
MexicoPA05005736► 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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Supplementary Protection Certificates for Tradename: CHOLINE FENOFIBRATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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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.