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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
AstraZeneca
QuintilesIMS
Medtronic
Moodys
Chinese Patent Office
Queensland Health
McKesson
Cantor Fitzgerald

Generated: July 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022118

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NDA 022118 describes FENOGLIDE, which is a drug marketed by Santarus Inc and is included in one NDA. It is available from four suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FENOGLIDE profile page.

The generic ingredient in FENOGLIDE is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 022118
Tradename:FENOGLIDE
Applicant:Santarus Inc
Ingredient:fenofibrate
Patents:4
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 022118
Medical Subject Heading (MeSH) Categories for 022118
Suppliers and Packaging for NDA: 022118
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOGLIDE fenofibrate TABLET;ORAL 022118 NDA AUTHORIZED GENERIC Impax Generics 0115-1522 N 0115-1522-10
FENOGLIDE fenofibrate TABLET;ORAL 022118 NDA AUTHORIZED GENERIC Impax Generics 0115-1523 N 0115-1523-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Aug 10, 2007TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Dec 9, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Oct 1, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:FOR REDUCING TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-LIPOPROTEIN B, OR TOTAL TRIGLYCERIDES, AND TREATING HYPERTRIGLYCERIDEMIA
Patent:➤ Try a Free TrialPatent Expiration:Oct 1, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF FENOFIBRATE FOR REDUCING ELEVATED TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-LIPOPROTEIN B, OR TOTAL TRIGLYCERIDES

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
US Army
Fish and Richardson
Mallinckrodt
Accenture
Julphar
Daiichi Sankyo
Dow
McKinsey

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