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UBS
US Department of Justice
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QuintilesIMS
Express Scripts
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Generated: November 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021656

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NDA 021656 describes TRICOR, which is a drug marketed by Abbvie and Abbvie Inc and is included in three NDAs. It is available from eleven suppliers. There are nine patents protecting this drug and two Paragraph IV challenges. Additional details are available on the TRICOR profile page.

The generic ingredient in TRICOR 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 021656
Tradename:TRICOR
Applicant:Abbvie
Ingredient:fenofibrate
Patents:7
Formulation / Manufacturing:see details
Pharmacology for NDA: 021656
Medical Subject Heading (MeSH) Categories for 021656
Suppliers and Packaging for NDA: 021656
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRICOR fenofibrate TABLET;ORAL 021656 NDA AbbVie Inc. 0074-3173 0074-3173-90 90 TABLET in 1 BOTTLE (0074-3173-90)
TRICOR fenofibrate TABLET;ORAL 021656 NDA AbbVie Inc. 0074-3189 0074-3189-90 90 TABLET in 1 BOTTLE (0074-3189-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength48MG
Approval Date:Nov 5, 2004TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 9, 2018Product Flag?Substance Flag?YDelist Request?
Patent:➤ Try a Free TrialPatent Expiration:Sep 21, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:ADJUNCTIVE THERAPY TO DIET IN ADULTS TO REDUCE LDL-C, TOTAL-C, TRIGLYCERIDES AND APO B, AND INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED DYSLIPIDEMIA (TYPES IIA, IIB) AND TO TREAT HYPERTRIGLYCERIDEMIA (TYPES IV, V)
Patent:➤ Try a Free TrialPatent Expiration:Jan 9, 2018Product Flag?Substance Flag?YDelist Request?

Expired US Patents for NDA 021656

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie TRICOR fenofibrate TABLET;ORAL 021656-002 Nov 5, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie TRICOR fenofibrate TABLET;ORAL 021656-002 Nov 5, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie TRICOR fenofibrate TABLET;ORAL 021656-001 Nov 5, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie TRICOR fenofibrate TABLET;ORAL 021656-001 Nov 5, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
QuintilesIMS
Colorcon
Farmers Insurance
Fish and Richardson
Julphar
Teva
Citi
AstraZeneca

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