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FENOFIBRATE - Generic Drug Details

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What are the generic 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, Amerigen Pharms Ltd, Apotex Inc, Cnty Line Pharms, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Mylan Pharms Inc, Rhodes Pharms, Abbvie, Cipher Pharms Inc, Amneal Pharms Llc, Aurobindo Pharma Ltd, Cipla Ltd, Hetero Labs Ltd Iii, Lupin Ltd, Mylan, Valeant Pharms North, Santarus Inc, Abbvie Inc, and Skyepharma Ag, and is included in thirty-four 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-five 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:	23
NDAs:	34
Drug Master File Entries:	42
Suppliers / Packagers:	55
Bulk Api Vendors:	96
Clinical Trials:	140
Patent Applications:	6,482
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FENOFIBRATE
DailyMed Link:	FENOFIBRATE at DailyMed

Pharmacology for FENOFIBRATE

Ingredient-type	PPAR alpha
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
		43MG	CAPSULE; ORAL
		130MG	CAPSULE; ORAL

US Patents and Regulatory Information for FENOFIBRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Skyepharma Ag	TRIGLIDE	fenofibrate	TABLET;ORAL	021350-001	May 7, 2005		DISCN	No	No			Y	Y
Lupin Ltd	FENOFIBRATE	fenofibrate	TABLET;ORAL	204019-001	Aug 17, 2015	AB	RX	No	No
Amneal Pharms Llc	FENOFIBRATE	fenofibrate	TABLET;ORAL	209950-002	Mar 19, 2018	AB	RX	No	No
Lupin Atlantis	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-001	Nov 30, 2004	AB	RX	Yes	No			Y	Y

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Expired US Patents for FENOFIBRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lupin Atlantis	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-002	Nov 30, 2004
Abbvie Inc	TRICOR	fenofibrate	TABLET;ORAL	021203-001	Sep 4, 2001
Abbvie	TRICOR	fenofibrate	TABLET;ORAL	021656-001	Nov 5, 2004
Abbvie Inc	TRICOR	fenofibrate	TABLET;ORAL	021203-003	Sep 4, 2001

Non-Orange Book US Patents for FENOFIBRATE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,529,952	Pharmaceutical composition containing fenofibrate and method for the preparation thereof
8,563,042	Pharmaceutical composition containing fenofibrate and method for the preparation thereof
8,658,212	Pharmaceutical composition containing fenofibrate and method for the preparation thereof
7,772,273	Stabilized atorvastatin

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International Patents for FENOFIBRATE

Country	Document Number	Estimated Expiration
Japan	2004523552
Taiwan	I347198
Hong Kong	1131051
Canada	2540984