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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
QuintilesIMS
Fish and Richardson
Daiichi Sankyo
Merck
Chubb
Julphar
US Army
Dow

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021350

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NDA 021350 describes TRIGLIDE, which is a drug marketed by Skyepharma Ag and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug. Additional details are available on the TRIGLIDE profile page.

The generic ingredient in TRIGLIDE is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 021350
Tradename:TRIGLIDE
Applicant:Skyepharma Ag
Ingredient:fenofibrate
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 021350
Medical Subject Heading (MeSH) Categories for 021350
Suppliers and Packaging for NDA: 021350
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRIGLIDE fenofibrate TABLET;ORAL 021350 NDA Shionogi Inc. 59630-485 E 59630-485-30
TRIGLIDE fenofibrate TABLET;ORAL 021350 NDA Casper Pharma LLC 70199-013 N 70199-013-30

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:May 7, 2005TE:RLD:No
Patent:➤ Sign UpPatent Expiration:Sep 11, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:A METHOD OF TREATING DYSLIPIDEMIA AND DYSLIPOPROTEINEMIA USING A DOSAGE FORM THAT CAN PROVIDE AN EFFECTIVE AMOUNT OF FENOFIBRATE TO A PATIENT IN A FASTED STATE WHICH IS AT LEAST 90% OF THE AUC AMOUNT PROVIDED BY THE DOSAGE FORM

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:May 7, 2005TE:BXRLD:Yes
Patent:➤ Sign UpPatent Expiration:Sep 11, 2021Product Flag?YSubstance Flag?YDelist Request?
Patented Use:A METHOD OF TREATING DYSLIPIDEMIA AND DYSLIPOPROTEINEMIA USING A DOSAGE FORM THAT CAN PROVIDE AN EFFECTIVE AMOUNT OF FENOFIBRATE TO A PATIENT IN A FASTED STATE WHICH IS AT LEAST 90% OF THE AUC AMOUNT PROVIDED BY THE DOSAGE FORM

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Accenture
Federal Trade Commission
Baxter
Chubb
Citi
Dow
Boehringer Ingelheim
Medtronic

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