Fenofibrate - Generic Drug Details

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What are the generic drug sources for fenofibrate and what is the scope of 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, Austarpharma, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Mylan Pharms Inc, Novast Labs, Rhodes Pharms, Torrent, Abbvie, Cipher Pharms Inc, Alembic Pharms Ltd, Amneal Pharms Llc, Aurobindo Pharma Ltd, Cipla, Graviti Pharms, Hetero Labs Ltd Iii, Lupin Ltd, Mylan, Nuvo Pharm, Orit Labs Llc, Prinston Inc, Sun Pharm, Valeant Pharms North, Salix, Abbvie Inc, and Skyepharma Ag, and is included in forty-three NDAs. There are twelve patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fenofibrate has three hundred and twenty-six patent family members in forty-six countries.

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

Summary for fenofibrate

International Patents:	326
US Patents:	12
Tradenames:	9
Applicants:	32
NDAs:	43
Drug Master File Entries:	42
Suppliers / Packagers:	51
Bulk Api Vendors:	112
Clinical Trials:	151
Patent Applications:	6,115
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for fenofibrate
Drug Sales Revenues:	Drug sales revenues for fenofibrate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fenofibrate
DailyMed Link:	fenofibrate at DailyMed

See drug prices for fenofibrate

Drug Sales Revenue Trends for fenofibrate

See drug sales revenues for fenofibrate

Recent Clinical Trials for fenofibrate

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

Sponsor	Phase
Singapore General Hospital	Phase 3
National Medical Research Council (NMRC), Singapore	Phase 3
Medical University of South Carolina	Phase 4

See all fenofibrate clinical trials

Recent Litigation for fenofibrate

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Arabella Petroleum Company, LLC	2015-07-10
Par Pharmaceutical, Inc. v. Twi Pharmaceuticals, Inc.	2014-04-01
Santarus Inc. v. Mylan Inc.	2013-01-28

See all fenofibrate litigation

Generic filers with tentative approvals for FENOFIBRATE

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	130MG	CAPSULE; ORAL
Start Trial	Start Trial	43MG	CAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for fenofibrate

Drug Class	Peroxisome Proliferator Receptor alpha Agonist

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-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
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
AC-4227
AC1L1FPK
AJ-23609
AKOS005107777
ALBB-028958
AN-9654
Ankebin
Antara
Antara (micronized)
Antara (TN)
ANW-41658
API0003184
API0025994
API0026002
API0026009
AX8021009
BC202978
BCP21243
BDBM50085042
BG0483
BIDD:GT0574
BPBio1_000166
BRD-K50388907-001-05-6
BRD-K50388907-001-18-9
BRD-K50388907-001-20-5
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
CPD000058299
CS-0892
CTK8B3039
D00565
DB01039
DivK1c_000557
DSSTox_CID_9874
DSSTox_GSID_29874
DSSTox_RID_78828
DTXSID2029874
EBD45918
EC 256-376-3
EINECS 256-376-3
Elasterate
Elasterin
EU-0100486
F 6020
F0674
Fenobrate
Fenofibrate (JAN/INN)
FENOFIBRATE (MICRONIZED)
FENOFIBRATE (MICRONIZED) (fenofibrate
Fenofibrate (Tricor, Trilipix)
Fenofibrate [INN:BAN]
Fenofibrate [USAN:USP:INN:BAN]
Fenofibrate IDD-P
Fenofibrate, >=99%, powder
Fenofibrate, 98%
Fenofibrate, analytical reference material
Fenofibrate, European Pharmacopoeia (EP) Reference Standard
Fenofibrate, Pharmaceutical Secondary Standard; Certified Reference Material
Fenofibrate, United States Pharmacopeia (USP) Reference Standard
Fenofibrate,(S)
fenofibrate;
Fenofibrato
Fenofibrato [INN-Spanish]
Fenofibratum
Fenofibratum [INN-Latin]
Fenogal
Fenoglide
Fenomax
Fenotard
Fibricor
Finofibrate
FNF
FT-0626400
FT-0654669
Fulcro
GP4850
GRS-027
GTPL7186
HMS1568H12
HMS1921B17
HMS2090G20
HMS2092B05
HMS2095H12
HMS2231B14
HMS3259K03
HMS3261B13
HMS3369M13
HMS3649D20
HMS3655K12
HMS3712H12
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
KS-00000655
LCP-Feno
LCP-FenoChol
LF 178
LF-178
Lipanthyl
Lipantil
Lipantil (TN)
Lipidex
Lipidil
Lipidil Micro
Lipidil Supra
Lipifen
Lipirex
Lipoclar
Lipofen
Lipofen (TN)
Lipofene
Liposit
Lipsin
Lofibra
Lopac-F-6020
Lopac0_000486
LP00486
LS-121256
Luxacor
MCULE-9460650238
methylethyl 2-{4-[(4-chlorophenyl)carbonyl]phenoxy}-2-methylpropanoate
MFCD00133314
MLS000028515
MLS001148191
MLS002548878
MolPort-002-887-051
MS-2223
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
NSC 281319
NSC-281319
NSC-757822
NSC281319
NSC757822
Opera_ID_328
Pharmakon1600-01501010
Pharmavit
Phenofibrate
Prestwick_217
Prestwick0_000275
Prestwick1_000275
Prestwick2_000275
Prestwick3_000275
Procetofen
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
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-201111
s1794
SAM002264613
SBB037926
SBI-0050470.P003
SCHEMBL4670
Secalip
Sedufen
SMR000058299
SPBio_001380
SPBio_002369
Spectrum_001250
SPECTRUM1501010
Spectrum2_001390
Spectrum3_001431
Spectrum4_000413
Spectrum5_001479
SR-01000000091
SR-01000000091-16
SR-01000000091-2
SR-01000000091-5
SR-01000000091-6
SR-01000000091-8
ST085313
Supralip
SW196525-4
TC-130403
TL8003296
Tox21_110147
Tox21_110147_1
Tox21_300151
Tox21_500486
Tricor
TRICOR (MICRONIZED)
Tricor (TN)
Triglide
Triglide (TN)
U202363UOS
UNII-U202363UOS
YMTINGFKWWXKFG-UHFFFAOYSA-N
Z2768724415
ZB014484
ZINC584092
ZX-AN079771

Paragraph IV (Patent) Challenges for FENOFIBRATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
FENOGLIDE	TABLET;ORAL	fenofibrate	022118	2010-03-17
ANTARA (MICRONIZED)	CAPSULE;ORAL	fenofibrate	021695	2008-09-15
TRICOR	TABLET;ORAL	fenofibrate	021656	2008-07-01
TRICOR	TABLET;ORAL	fenofibrate	021656	2007-10-19
LIPIDIL	CAPSULE;ORAL	fenofibrate	019304
TRICOR (MICRONIZED)	CAPSULE;ORAL	fenofibrate	019304
TRICOR	TABLET;ORAL	fenofibrate	021203

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
Hetero Labs Ltd Iii	FENOFIBRATE	fenofibrate	TABLET;ORAL	204598-002	Jul 12, 2016	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Novast Labs	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	207564-001	Apr 19, 2019	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Nuvo Pharm	FENOFIBRATE	fenofibrate	TABLET;ORAL	210670-001	Sep 6, 2019	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Mylan Pharms Inc	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	202676-003	Oct 23, 2012	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-002	Jan 11, 2006		DISCN	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

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	Start Trial	Start Trial
Abbvie Inc	TRICOR	fenofibrate	TABLET;ORAL	021203-001	Sep 4, 2001	Start Trial	Start Trial
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-001	Nov 5, 2004	Start Trial	Start Trial
Abbvie	TRICOR (MICRONIZED)	fenofibrate	CAPSULE;ORAL	019304-003	Jun 30, 1999	Start Trial	Start Trial
Abbvie Inc	TRICOR	fenofibrate	TABLET;ORAL	021203-001	Sep 4, 2001	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for fenofibrate

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Country	Patent Number	Estimated Expiration
France	2795961	Start Trial
Japan	2004513886	Start Trial
South Korea	20060085686	Start Trial
Japan	4758548	Start Trial
Spain	2372746	Start Trial
>Country	>Patent Number	>Estimated Expiration

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