Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 11, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022224

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NDA 022224 describes TRILIPIX, which is a drug marketed by Abbvie and is included in one NDA. It is available from four suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the TRILIPIX profile page.

The generic ingredient in TRILIPIX is choline fenofibrate. There are one hundred and two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the choline fenofibrate profile page.
Summary for 022224
Tradename:TRILIPIX
Applicant:Abbvie
Ingredient:choline fenofibrate
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 022224
Suppliers and Packaging for NDA: 022224
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRILIPIX choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 022224 NDA AbbVie Inc. 0074-3161 0074-3161-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0074-3161-90)
TRILIPIX choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 022224 NDA AbbVie Inc. 0074-3162 0074-3162-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0074-3162-90)
Paragraph IV (Patent) Challenges for 022224
Tradename Dosage Ingredient NDA Submissiondate
TRILIPIX CAPSULE, DELAYED RELEASE;ORAL choline fenofibrate 022224 2009-09-02
TRILIPIX CAPSULE, DELAYED RELEASE;ORAL choline fenofibrate 022224 2009-09-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 45MG FENOFIBRIC ACID
Approval Date:Dec 15, 2008TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jan 7, 2025Product Flag?Substance Flag?YDelist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 135MG FENOFIBRIC ACID
Approval Date:Dec 15, 2008TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jan 7, 2025Product Flag?Substance Flag?YDelist Request?

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