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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022118


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NDA 022118 describes FENOGLIDE, which is a drug marketed by Salix and is included in one NDA. It is available from two 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-five suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 022118
Tradename:FENOGLIDE
Applicant:Salix
Ingredient:fenofibrate
Patents:4
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 Amneal Pharmaceuticals of New York LLC 0115-1522 0115-1522-10 90 TABLET in 1 BOTTLE (0115-1522-10)
FENOGLIDE fenofibrate TABLET;ORAL 022118 NDA AUTHORIZED GENERIC Amneal Pharmaceuticals of New York LLC 0115-1523 0115-1523-10 90 TABLET in 1 BOTTLE (0115-1523-10)
Paragraph IV (Patent) Challenges for 022118
Tradename Dosage Ingredient NDA Submissiondate
FENOGLIDE TABLET;ORAL fenofibrate 022118 2010-03-17

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Aug 10, 2007TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Dec 9, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:  Start 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:  Start 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 leading biopharmaceutical companies globally:

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