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Last Updated: August 8, 2020

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Choline fenofibrate - Generic Drug Details

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What are the generic drug sources for choline fenofibrate and what is the scope of freedom to operate?

Choline fenofibrate is the generic ingredient in two branded drugs marketed by Actavis Elizabeth, Alembic Pharms Ltd, Anchen Pharms, Aurobindo Pharma Ltd, Graviti Pharms, Impax Labs Inc, Lupin Ltd, Mylan Pharms Inc, Twi Pharms, and Abbvie, and is included in ten 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 one hundred and two drug master file entries for choline fenofibrate. Twelve suppliers are listed for this compound.

Recent Clinical Trials for choline fenofibrate

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

SponsorPhase
Daewon Pharmaceutical Co., Ltd.Phase 4
Medpace, Inc.Phase 2
Essentialis, Inc.Phase 2

See all choline fenofibrate clinical trials

Pharmacology for choline fenofibrate
Paragraph IV (Patent) Challenges for CHOLINE FENOFIBRATE
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

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
Impax Labs Inc FENOFIBRIC ACID choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 200264-002 Sep 7, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc FENOFIBRIC ACID choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 200913-001 Mar 25, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Graviti Pharms FENOFIBRIC ACID choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 211626-002 Jul 18, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Anchen Pharms FENOFIBRIC ACID choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 201573-001 Jul 18, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Actavis Elizabeth FENOFIBRIC ACID choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 200920-001 Oct 7, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for choline fenofibrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0050793 94C0009 Belgium   Start Trial PRODUCT NAME: COLFOSCERIL PALMITAS (DIPALMITOYLPHOSPHATIDYLCHOLINE) (DPPC); NAT REG.: 251 IS 142 F 12; FIRST REG.: GB PL 0003/0283 19901214
1746976 LUC00026 Luxembourg   Start 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) (MOLECULAR WEIGHT 2000)-OXYCARBONYL)-1,2-DISTEAROYLPHOSPHATIDYL ETHANOLAMINE, E.G. IN THE MOLAR RATIO 3:2:0.015; AUTHORISATION NUMBER AND DATE: EU/1/16/1130 20161018
1758590 300907 Netherlands   Start Trial PRODUCT NAME: DEOXYCHOLINEZUUR NATRIUMZOUT
1746976 2017C/027 Belgium   Start 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
1746976 CA 2017 00030 Denmark   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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