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Fenofibrate - Generic Drug Details

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

Fenofibrate is the generic ingredient in nine branded drugs marketed by Lupin Atlantis, Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Amerigen Pharms Ltd, Apotex Inc, Cnty Line Pharms, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Mylan Pharms Inc, Rhodes Pharms, Torrent Pharms Ltd, Abbvie, Cipher Pharms Inc, Amneal Pharms Llc, Aurobindo Pharma Ltd, Cipla, Graviti Pharms, Hetero Labs Ltd Iii, Lupin Ltd, Mylan, Prinston Inc, Valeant Pharms North, Santarus Inc, Abbvie Inc, and Skyepharma Ag, and is included in thirty-nine NDAs. There are eighteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fenofibrate has four hundred and seventeen patent family members in forty-nine countries.

There are forty-two drug master file entries for fenofibrate. Fifty-three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for fenofibrate

International Patents:	417
US Patents:	18
Tradenames:	9
Applicants:	27
NDAs:	39
Drug Master File Entries:	42
Suppliers / Packagers:	53
Bulk Api Vendors:	102
Clinical Trials:	148
Patent Applications:	6,504
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for fenofibrate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fenofibrate
DailyMed Link:	fenofibrate at DailyMed

Pharmacology for fenofibrate

Drug Class	Peroxisome Proliferator Receptor alpha Agonist
Mechanism of Action	Peroxisome Proliferator-activated Receptor alpha Agonists

Medical Subject Heading (MeSH) Categories for fenofibrate

Hypolipidemic Agents

Synonyms for fenofibrate

2-(4-(4-Chlorobenzoyl)phenoxy)-2-methylpropanoic acid 1-methylethyl ester
2-[4-(4-CHLOROBENZOYL)PHENOXY]-2-METHYL-PROPANOIC ACID 1-METHYLETHYL ESTER
2-[4-(4-chlorobenzoyl)phenoxy]-2-methyl-propanoic acid,1-methylethylester
2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropanoic acid 1-methyl-ethyl ester
2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropanoic acid 1-methylethyl ester
2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropanoic acid isopropyl ester
2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoicacidisopropylester
2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropionic Acid Isopropyl Ester
2-[4-[(4-chlorophenyl)-oxomethyl]phenoxy]-2-methylpropanoic acid propan-2-yl ester
2-1-methylethyl 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate
28073-EP2272825A2
28073-EP2272841A1
28073-EP2277565A2
28073-EP2277566A2
28073-EP2277567A1
28073-EP2277568A2
28073-EP2277569A2
28073-EP2277570A2
28073-EP2287163A1
28073-EP2287165A2
28073-EP2287166A2
28073-EP2292280A1
28073-EP2292620A2
28073-EP2295409A1
28073-EP2298742A1
28073-EP2298776A1
28073-EP2301923A1
28073-EP2301936A1
28073-EP2305678A1
28073-EP2314588A1
49562-28-9
562F289
A827746
AB00052196
AB00052196_17
AB00052196_18
AB00052196-15
AB00052196-16
AB0012237
AB03716
AB2000298
Abbott Brand of Procetofen
AbZ Brand of Procetofen
AC-4227
AC1L1FPK
AJ-23609
AK-88651
AKOS005107777
ALBB-028958
Aliud Brand of Procetofen
AN-9654
Ankebin
Antara
Antara (micronized)
Antara (TN)
Antara Micronized Procetofen
Anto Brand of Procetofen
ANW-41658
API0003184
API0025994
API0026002
API0026009
Apo Feno Micro
Apo Fenofibrate
Apo-Feno-Micro
Apo-Fenofibrate
Apotex Brand of Procetofen
AX8021009
AZU, Fenofibrat
Azupharma Brand of Procetofen
BC202978
BDBM50085042
betapharm Brand of Procetofen
BG0483
BIDD:GT0574
Bouchara Brand of Procetofen
BPBio1_000166
BRD-K50388907-001-05-6
BRD-K50388907-001-18-9
BRN 2062462
BSPBio_000150
BSPBio_003162
C-20905
C07586
C20H21ClO4
CAS-49562-28-9
CC-28385
CCG-38996
CCRIS 7282
CHEBI:5001
CHEMBL672
CIP-Fenofibrate
clorofibrate
Controlip
CPD000058299
CS-0892
ct Arzneimittel Brand of Procetofen
ct-Arzneimittel Brand of Procetofen
CTK8B3039
D00565
D07XGR
DB01039
Debat, Fenofibrate
DivK1c_000557
DR001912
DSSTox_CID_9874
DSSTox_GSID_29874
DSSTox_RID_78828
DTXSID2029874
durafenat
EBD45918
EC 256-376-3
EINECS 256-376-3
Elasterate
Elasterin
EU-0100486
F 6020
F0674
Fenobeta
Fenobrate
Fenocor-67 (TN)
Fenofanton
Fenofibrat AbZ
Fenofibrat AL
Fenofibrat AZU
Fenofibrat FPh
Fenofibrat Heumann
Fenofibrat Hexal
Fenofibrat ratiopharm
Fenofibrat Stada
fenofibrat von ct
Fenofibrat-ratiopharm
Fenofibrate (JAN/INN)
FENOFIBRATE (MICRONIZED)
FENOFIBRATE (MICRONIZED) (fenofibrate
Fenofibrate (Tricor, Trilipix)
Fenofibrate [INN:BAN]
Fenofibrate [USAN:USP:INN:BAN]
Fenofibrate Debat
Fenofibrate IDD-P
Fenofibrate MSD
Fenofibrate, >=99%, powder
Fenofibrate, analytical reference material
Fenofibrate, European Pharmacopoeia (EP) Reference Standard
Fenofibrate, pharmaceutical secondary standard; traceable to USP and PhEur
Fenofibrate, United States Pharmacopeia (USP) Reference Standard
fenofibrate;
Fenofibrato
Fenofibrato [INN-Spanish]
Fenofibratum
Fenofibratum [INN-Latin]
FENOFIBRITE
Fenogal
Fenogal (TN)
Fenoglide
Fenomax
Fenotard
Fibricor
Finofibrate
FNF
Fournier Brand of Procetofen
FT-0626400
FT-0654669
Fulcro
Gate Brand of Procetofen
Gen Fenofibrate
Gen-Fenofibrate
Genpharm Brand of Procetofen
GNR Pharma Brand of Procetofen
GNR-Pharma Brand of Procetofen
GP4850
GRS-027
GTPL7186
Heumann Brand of Procetofen
Heumann, Fenofibrat
Hexal Brand of Procetofen
Hexal, Fenofibrat
HMS1568H12
HMS1921B17
HMS2090G20
HMS2092B05
HMS2095H12
HMS2231B14
HMS3259K03
HMS3261B13
HMS3369M13
HMS3649D20
HMS3655K12
HMS501L19
HSDB 7736
HY-17356
I06-0048
IDI1_000557
Isopropyl (4'-(p-chlorobenzoyl)-2-phenoxy-2-methyl)propionate
Isopropyl (4''-(p-chlorobenzoyl)-2-phenoxy-2-methyl)propionate
Isopropyl 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoate
Isopropyl 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropionate
Isopropyl 2-(p-(p-chlorobenzoyl)phenoxy)-2-methylpropionate
isopropyl 2-[4-(4-chlorobenzoyl)phenoxy]-2-methyl-propanoate
isopropyl 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate
Isopropyl 2-[4-(4-Chlorobenzoyl)phenoxy]-2-methylpropionate
Isopropyl 2-[p-(p-chlorobenzoyl)phenoxy]-2-methylpropionate
J10318
K-9221
KBio1_000557
KBio2_001730
KBio2_004298
KBio2_006866
KBio3_002382
KBioGR_000706
KBioSS_001730
Knoll Brand of Procetofen
KS-00000655
LCP-Feno
LCP-FenoChol
LF 178
LF-178
LF178
Lichtenstein Brand of Procetofen
Lipanthyl
Lipanthyl (TN)
Lipantil
Lipantil (TN)
Liparison
Lipidex
Lipidil
Lipidil (TN)
Lipidil Micro
Lipidil Supra
Lipidil Ter
Lipidil-Ter
Lipifen
Lipirex
Lipoclar
Lipofen
Lipofen (TN)
Lipofene
Liposit
Lipsin
Lofibra
Lofibra (TN)
Lopac-F-6020
Lopac0_000486
LP00486
LS-121256
Luxacor
MCULE-9460650238
Merck dura Brand of Procetofen
METHYLETHYL 2-(4-[(4-CHLOROPHENYL)CARBONYL]PHENOXY)-2-METHYLPROPANOATE
methylethyl 2-{4-[(4-chlorophenyl)carbonyl]phenoxy}-2-methylpropanoate
MFCD00133314
Micronized Procetofen, Antara
MLS000028515
MLS001148191
MLS002548878
MolPort-002-887-051
MS-2223
MTW Brand of Procetofen
MTW Fenofibrat
MTW-Fenofibrat
NC00452
NCGC00015437-01
NCGC00015437-02
NCGC00015437-03
NCGC00015437-04
NCGC00015437-05
NCGC00015437-06
NCGC00015437-07
NCGC00015437-08
NCGC00015437-09
NCGC00015437-10
NCGC00015437-11
NCGC00015437-12
NCGC00015437-13
NCGC00015437-14
NCGC00015437-16
NCGC00015437-17
NCGC00021475-03
NCGC00021475-04
NCGC00021475-05
NCGC00021475-06
NCGC00021475-07
NCGC00021475-08
NCGC00253945-01
NCGC00261171-01
NINDS_000557
Nolipax
Novartis Brand of Procetofen
Novo Fenofibrate
Novo-Fenofibrate
Novopharm Brand of Procetofen
NSC 281319
NSC-281319
NSC-757822
NSC281319
NSC757822
Nu Fenofibrate
Nu Pharm Brand of Procetofen
Nu-Fenofibrate
Nu-Pharm Brand of Procetofen
Opera_ID_328
OR108780
OR273579
OR273580
Pharmakon1600-01501010
Pharmascience Brand of Procetofen
Pharmavit
Phenofibrate
PMS Fenofibrate Micro
PMS-Fenofibrate Micro
Prestwick_217
Prestwick0_000275
Prestwick1_000275
Prestwick2_000275
Prestwick3_000275
Procetofen
Procetofen Reliant Brand
Procetofen, Antara Micronized
Procetofene
Procetoken
Proctofene
propan-2-yl 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate
propan-2-yl 2-[4-(4-chlorophenyl)carbonylphenoxy]-2-methyl-propanoate
propan-2-yl 2-{4-[(4-chlorophenyl)carbonyl]phenoxy}-2-methylpropanoate
PROPAN-2-YL-2-(4-[(4-CHLOROPHENYL)CARBONYL]PHENOXY)-2-METHYLPROPANOATE
Propanoic acid, 2-(4-(4-chlorobenzoyl)phenoxy)-2-methyl-, 1-methylethyl ester
Propanoic acid, 2-[4-(4-chlorobenzoyl)phenoxy]-2-methyl-, 1-methylethyl ester
Protolipan
PubChem17489
Q Pharm Brand of Procetofen
Q-201111
Q-Pharm Brand of Procetofen
ratiopharm Brand of Procetofen
Reliant Brand of Procetofen
s1794
SAM002264613
SBB037926
SBI-0050470.P003
SCHEMBL4670
Schering Plough Brand of Procetofen
Schering-Plough Brand of Procetofen
Secalip
Sedufen
SMR000058299
SPBio_001380
SPBio_002369
Spectrum_001250
SPECTRUM1501010
Spectrum2_001390
Spectrum3_001431
Spectrum4_000413
Spectrum5_001479
SR-01000000091
SR-01000000091-16
SR-01000000091-5
ST085313
Stada, Fenofibrat
Stadapharm Brand of Procetofen
Supralip
TC-130403
TL8003296
Tox21_110147
Tox21_110147_1
Tox21_300151
Tox21_500486
Tricor
TRICOR (MICRONIZED)
Tricor (TN)
Triglide
Triglide (TN)
U202363UOS
UNII-U202363UOS
United Drug Brand of Procetofen
YMTINGFKWWXKFG-UHFFFAOYSA-N
Z2768724415
ZB014484
ZINC584092
ZX-AN079771

Tentative approvals for FENOFIBRATE

Applicant	Application No.	Strength	Dosage Form
➤ Try a Free Trial	➤ Try a Free Trial	130MG	CAPSULE; ORAL
➤ Try a Free Trial	➤ Try a Free Trial	43MG	CAPSULE; ORAL

US Patents and Regulatory Information for fenofibrate

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin Ltd	FENOFIBRATE	fenofibrate	TABLET;ORAL	090856-001	Dec 23, 2011	AB	RX	No	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Valeant Pharms North	FENOFIBRATE	fenofibrate	TABLET;ORAL	090715-001	Apr 5, 2012	AB	RX	No	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Torrent Pharms Ltd	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	210782-001	Jun 26, 2018	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

Expired US Patents for fenofibrate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie Inc	TRICOR	fenofibrate	TABLET;ORAL	021203-003	Sep 4, 2001	➤ Try a Free Trial	➤ Try a Free Trial
Abbvie Inc	TRICOR	fenofibrate	TABLET;ORAL	021203-003	Sep 4, 2001	➤ Try a Free Trial	➤ Try a Free Trial
Abbvie Inc	TRICOR	fenofibrate	TABLET;ORAL	021203-001	Sep 4, 2001	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

International Patents for fenofibrate

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Country	Document Number	Estimated Expiration
Japan	2007507486	➤ Try a Free Trial
Iceland	2157	➤ Try a Free Trial
India	187906	➤ Try a Free Trial
Country	Document Number	Estimated Expiration