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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, Ajanta Pharma Ltd, Amerigen Pharms Ltd, Apotex Inc, Austarpharma, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Mylan Pharms Inc, Rhodes Pharms, Torrent, Abbvie, Cipher Pharms Inc, Amneal Pharms Llc, Aurobindo Pharma Ltd, Cipla, Graviti Pharms, Hetero Labs Ltd Iii, Lupin Ltd, Mylan, Orit Labs Llc, Prinston Inc, Valeant Pharms North, Santarus Inc, Abbvie Inc, and Skyepharma Ag, and is included in forty 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-five patent family members in forty-six countries.

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

Summary for FENOFIBRATE

International Patents:	325
US Patents:	12
Tradenames:	9
Applicants:	28
NDAs:	40
Drug Master File Entries:	42
Suppliers / Packagers:	56
Bulk Api Vendors:	105
Clinical Trials:	151
Patent Applications:	6,007
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

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-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

Generic filers with tentative approvals for FENOFIBRATE

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

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
Apotex Inc	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	202252-002	Jul 26, 2013	AB	RX	No	No
Graviti Pharms	FENOFIBRATE	fenofibrate	TABLET;ORAL	210606-002	Aug 17, 2018		DISCN	No	No
Impax Labs	FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	075868-002	Oct 27, 2003	AB	RX	No	No
Sun Pharm Inds Ltd	FENOFIBRATE	fenofibrate	TABLET;ORAL	076635-003	Oct 31, 2005	AB	RX	No	No

Expired US Patents for FENOFIBRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie Inc	TRICOR	fenofibrate	TABLET;ORAL	021203-001	Sep 4, 2001
Abbvie Inc	TRICOR	fenofibrate	TABLET;ORAL	021203-001	Sep 4, 2001
Cipher Pharms Inc	LIPOFEN	fenofibrate	CAPSULE;ORAL	021612-003	Jan 11, 2006
Lupin Atlantis	ANTARA (MICRONIZED)	fenofibrate	CAPSULE;ORAL	021695-001	Nov 30, 2004

International Patents for FENOFIBRATE

Country	Patent Number	Estimated Expiration
Hong Kong	1074588
Russian Federation	2343905
South Korea	101300654
Argentina	072134