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Queensland Health
Deloitte
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Generated: June 26, 2019

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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 choline fenofibrate patent protection?

Choline fenofibrate is the generic ingredient in two branded drugs marketed by Actavis Elizabeth, Alembic Pharms Ltd, Anchen Pharms, Impax Labs Inc, Lupin Ltd, Mylan Pharms Inc, and Abbvie, and is included in seven 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. Eight suppliers are listed for this compound.

Pharmacology for CHOLINE FENOFIBRATE
Synonyms for CHOLINE FENOFIBRATE
1034151-05-7
2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate,2-hydroxyethyl(trimethyl)azanium
2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid choline salt
2-Hydroxy-N,N,N-trimethylethanaminium 2-(-(4-chlorobenzoyl)phenoxy)-2- methylpropanoate
2-Hydroxy-N,N,N-trimethylethanaminium 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoate
2-Hydroxy-N,N,N-trimethylethanaminium 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate
2-Hydroxy-N,N,N-trimethylethanaminium2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoate
3320AC
4BMH7IZT98
856676-23-8
ABT 335
Abt 335;abt-335;abt335
ABT-335
AKOS016010592
API0009427
AS-10210
AX8245113
BCP28592
CHEMBL1201745
Choline fenofibrate (ABT-335)
Choline fenofibrate (USAN/INN)
Choline fenofibrate [USAN:INN]
CS-0893
CTK8E8257
D08890
DTXSID50234939
Ethanaminium, 2-hydroxy-N,N,N-trimethyl-, salt with 2-(4-(4- chlorobenzoyl)phenoxy)-2-methylpropanoic acid (1:1)
Fenofibrate de choline
Fenofibric acid (TN)
FT-0665026
HIP0901
HY-14739
JWAZHODZSADEHB-UHFFFAOYSA-M
KS-00000R22
MolPort-006-393-282
RT-012006
ST24040685
Trilipix
UNII-4BMH7IZT98
Unii-4bmh7izt98 BFenofibrate de choline
W-5743

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
Mylan Pharms Inc FENOFIBRIC ACID choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 200913-001 Mar 25, 2013 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Alembic Pharms Ltd FENOFIBRIC ACID choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 208705-001 May 12, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Actavis Elizabeth FENOFIBRIC ACID choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 200920-001 Oct 7, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for CHOLINE FENOFIBRATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1758590 300907 Netherlands ➤ Try a Free Trial PRODUCT NAME: DEOXYCHOLINEZUUR NATRIUMZOUT
0050793 94C0009 Belgium ➤ Try a Free Trial PRODUCT NAME: COLFOSCERIL PALMITAS (DIPALMITOYLPHOSPHATIDYLCHOLINE) (DPPC); NAT REG.: 251 IS 142 F 12; FIRST REG.: GB PL 0003/0283 19901214
1746976 LUC00026 Luxembourg ➤ Try a Free 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
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
QuintilesIMS
Chinese Patent Office
Covington
Cantor Fitzgerald
Julphar

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