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Last Updated: March 28, 2024

Choline fenofibrate - Generic Drug Details


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What are the generic drug sources for choline fenofibrate and what is the scope of patent protection?

Choline fenofibrate is the generic ingredient in two branded drugs marketed by Actavis Elizabeth, Alembic, Anchen Pharms, Aurobindo Pharma Ltd, Graviti Pharms, Impax Labs Inc, Lupin Ltd, Micro Labs, Mylan Pharms Inc, Scinopharm Taiwan, Yichang Humanwell, and Abbvie, and is included in twelve NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Choline fenofibrate has nineteen patent family members in eleven countries.

There are ten drug master file entries for choline fenofibrate. Eleven suppliers are listed for this compound.

Recent Clinical Trials for choline fenofibrate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Seoul National University Bundang HospitalPhase 4
Daewon Pharmaceutical Co., Ltd.Phase 4
Essentialis, Inc.Phase 2

See all choline fenofibrate clinical trials

Pharmacology for choline fenofibrate
Paragraph IV (Patent) Challenges for CHOLINE FENOFIBRATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TRILIPIX Delayed-release Capsules choline fenofibrate 45 mg 022224 1 2009-09-02
TRILIPIX Delayed-release Capsules choline fenofibrate 135 mg 022224 1 2009-09-01

US Patents and Regulatory Information for choline fenofibrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Scinopharm Taiwan FENOFIBRIC ACID choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 210469-002 Jul 5, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie TRILIPIX choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 022224-001 Dec 15, 2008 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Anchen Pharms FENOFIBRIC ACID choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 201573-001 Jul 18, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for choline fenofibrate

Country Patent Number Title Estimated Expiration
Russian Federation 2500398 КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ ФЕНОФИБРИНОВУЮ КИСЛОТУ ИЛИ ЕЕ ФИЗИОЛОГИЧЕСКИ ПРИЕМЛЕМУЮ СОЛЬ, И КАПСУЛА, ВКЛЮЧАЮЩАЯ КОМПОЗИЦИЮ (COMPOSITION CONTAINING FENOFIBRIC ACID OR PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, AND CAPSULE CONTAINING COMPOSITION) ⤷  Try a Trial
China 101480384 Formulation comprising fenofibric acid, a physiologically acceptable salt or derivative thereof ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2004054568 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for choline fenofibrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1758590 300907 Netherlands ⤷  Try a Trial PRODUCT NAME: DEOXYCHOLINEZUUR NATRIUMZOUT; REGISTRATION NO/DATE: RVG120593 20170804
1746976 CA 2017 00030 Denmark ⤷  Try a Trial PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL)...; REG. NO/DATE: EU/1 /16/1130 20161018
1746976 2017C/027 Belgium ⤷  Try a Trial PRODUCT NAME: LE SEL DE SUCROSOFATE D'IRINOTECAN, PAR EXEMPLE LE SEL DE SUCROSOFATE D'IRINOTECAN INCORPORE DANS UN LIPOSOME MODIFIE PAR PEGYLATION, TEL QU'UN LIPOSOME COMPRENANT DE LA 1,2-DISTEAROYL-SN- PHOSPHATIDYLCHOLINE, DU CHOLESTEROL ET DU N- (OMEGA-METHOXY POLY (ETHYLENE GLYCOL) (POIDS MOLECULAIRE 2000) -OXYCARBONYL)-1,2-DISEEAROYLPHOSPHATIDYLETHANOLAMINE, PAR EXEMPLE DANS DES RAPPORTS MOLAIRES 3: 2: 0,015; OU COMME DEMANDE AUXILIAIRE, IRINOTECAN; AUTHORISATION NUMBER AND DATE: EU/1/16/1130 20161018
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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