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Baxter
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US Department of Justice
Accenture
Colorcon
Teva
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Generated: May 24, 2018

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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 freedom to operate?

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. Eleven suppliers are listed for this compound.
Pharmacology for choline fenofibrate
Synonyms for choline fenofibrate
1034151-05-7
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
AK119697
AKOS016010592
API0009427
AS-10210
AX8245113
CHEMBL1201745
Choline fenofibrate (ABT-335)
Choline fenofibrate (USAN/INN)
Choline fenofibrate [USAN:INN]
CS-0893
CTK8E8257
D01HKL
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
OR352514
RT-012006
ST24040685
Trilipix
UNII-4BMH7IZT98
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
Impax Labs Inc FENOFIBRIC ACID choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 200264-002 Sep 7, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Anchen Pharms FENOFIBRIC ACID choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 201573-001 Jul 18, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Pharms Inc FENOFIBRIC ACID choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 200913-001 Mar 25, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Abbvie TRILIPIX choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 022224-002 Dec 15, 2008 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2017 00030 Denmark ➤ Sign Up 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
0907 Netherlands ➤ Sign Up PRODUCT NAME: DEOXYCHOLINEZUUR NATRIUMZOUT
C0009 Belgium ➤ Sign Up PRODUCT NAME: COLFOSCERIL PALMITAS (DIPALMITOYLPHOSPHATIDYLCHOLINE) (DPPC); NAT REG.: 251 IS 142 F 12; FIRST REG.: GB PL 0003/0283 19901214
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
McKinsey
Federal Trade Commission
Fish and Richardson
Mallinckrodt
Chubb
Merck
Moodys
UBS

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