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LIPIDIL

NDA

FENOFIBRATE | N019304 | ABBVIE INC

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from HealthyWomen FDA-2024-P-1988 · 4 docket documents HealthyWomen filed this citizen petition under 21 C.F.R. § 10.30 requesting that the FDA revise labeling for all approved fenofibrate drugs to remedy healthcare professionals' misunderstanding that fenofibrates reduce cardiovascular risk and to incorporate results from the PROMINENT Study, and that	Other	2024-04-23	Granted	HealthyWomen
Citizen Petition from EAS Consulting Group (Jubilant Generics) FDA-2017-P-4245 · 4 docket documents Jubilant Generics Ltd., represented by EAS Consulting Group, filed this citizen petition on July 13, 2017, requesting that the FDA amend the Orange Book to designate "Reference Standard" (RS) status to a fenofibrate capsule product currently available in the market in strengths of 67 mg, 134 mg, and	505(q)	2017-07-14	Withdrawn	EAS Consulting Group (Jubilant Generics)
Lupin Atlantis Holdings, S.A., (Leydig, Voit & Mayer, Ltd.) - Citizen Petition FDA-2010-P-0092 · 4 docket documents Lupin Atlantis Holdings, S.A., through its legal counsel Leydig, Voit & Mayer, Ltd., filed this citizen petition on February 16, 2010, requesting that the FDA refrain from approving ANDA 91-362 submitted by Paddock Laboratories, Inc. for a generic version of Antara (fenofibrate) Capsules in 43 mg an	505(q) Stay Request	2010-02-23	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

135 trials from ClinicalTrials.gov, 1 active, 96 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Fenofibrate And Microvascular Events in Type 1 Diabetes Eye.NCT01320345	Phase 3	Active	University of Sydney	412	2016-11-03 → 2026-12
Effect of Genes on Rosuvastatin Therapy for Hyperlipidemia NCT00934258	—	AVAILABLE	National Taiwan University Hospital	—	—
A Multicenter Randomized Parallel-group Study to Investigate the Efficacy of a Combination of Rosuvastatin and Fenofibrate in the Patients With Diabetes or Atherosclerotic Vascular Diseases With Metabolic Syndrome NCT00965315	—	AVAILABLE	National Taiwan University Hospital	—	—
Bioequivalency Study of Fenofibrate 160mg Tablets Under Fasting Conditions NCT00775827	N/A	Completed	Ranbaxy Laboratories Limited	40	2002-11 → 2002-12
Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood NCT00616772	Phase 3	Completed	AbbVie (prior sponsor, Abbott)	682	2008-02 → 2012-09
12-Month, Open-Label, Extension Study of LCP-AtorFen in Dyslipidemia NCT00664859	Phase 2/3	Completed	Veloxis Pharmaceuticals	140	2007-10 → 2009-02
Differential Metabolic Effects of Fenofibrate and Fatty Acid NCT01003847	Phase 4	Completed	Gachon University Gil Medical Center	150	2009-11 → 2010-09
Diet, Exercise, Niacin, and Fenofibrate to Reduce Heart Disease Risk Factors in Individuals With HIV Lipodystrophy or Dyslipidemia NCT00246376	N/A	Completed	Baylor College of Medicine	221	2004-01 → 2012-02
Action to Control Cardiovascular Risk in Diabetes (ACCORD)NCT00000620	Phase 3	Completed	National Heart, Lung, and Blood Institute (NHLBI)	10,251	1999-09 → 2012-12
Assess HDL-C Increase And Non-HDL Lowering Effect Of Torcetrapib/Atorvastatin Vs. Fenofibrate NCT00139061	Phase 3	Completed	Pfizer	128	2005-03 → 2006-05

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain16 active DMFs16 inactive

14 active API suppliers hold Drug Master Files for this ingredient.

VANAMALI ORGANICS PVT LTDFENOFIBRATE

DMF 111941994

CORDEN PHARMA CHENOVEFENOFIBRATE

DMF 120781996

OLON SPAFENOFIBRATE

DMF 138011998

OLON SPAFENOFIBRATE

DMF 154382001

ALEMBIC PHARMACEUTICALS LTDFENOFIBRATE USP

DMF 162082002

CORDEN PHARMA CHENOVEFENOFIBRATE INTERMEDIATE DRUG SUBSTANCE

DMF 207252007

LUPIN LTDFENOFIBRATE USP

DMF 215512008

HARMAN FINOCHEM LTDFENOFIBRATE USP

DMF 232812009

TEVA PHARMACEUTICAL INDUSTRIES LTDFENOFIBRATE CHOLINE

DMF 235402010

DERIVADOS QUIMICOS SAUFENOFIBRATE

DMF 240322010

UNICHEM LABORATORIES LTDFENOFIBRATE USP

DMF 243932010

JIANGSU NHWA PHARMACEUTICAL CO LTDFENOFIBRATE

DMF 244532010

HETERO DRUGS LTDFENOFIBRATE, USP

DMF 260802012

ZHEJIANG YONGTAI PHARMACEUTICAL CO LTDFENOFIBRATE USP

DMF 289992015

IOL CHEMICALS AND PHARMACEUTICALS LTDFENOFIBRATE USP

DMF 365352022

SURAJ LABORATORIES PRIVATE LTDFENOFIBRATE USP

DMF 409382024

EPROVA AGInactiveFENOFIBRATE (PROCETOFEN)

DMF 64561986

LABORATOIRES FOURNIER SAInactiveFENOFIBRATE CAPSULES

DMF 69521987

PLAISTOW LTDInactiveFENOFIBRATE

DMF 72741987

CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTDInactiveFENOFIBRATE

DMF 106741993

ORGAPHARMInactiveFENOFIBRATE DRUG SUBSTANCE

DMF 141571999

COPRIMA SAInactiveFENOFIBRATE

DMF 154692001

PCASInactiveFENOFIBRATE

DMF 160652002

ABBOTT LABORATORIESInactiveFENOFIBRATE SPRAY GRANULATION INTERMEDIATE

DMF 168982003

ANONIMA MATERIE SINTETICHE AND AFFINI (AMSA) SPAInactiveFENOFIBRATE

DMF 169712003

LABORATOIRES FOURNIER SAInactiveFENOFIBRATE SPRAY GRANULATION INTERMEDIATE

DMF 190182005

IPCA LABORATORIES LTDInactiveFENOFIBRATE USP

DMF 216772008

MOEHS IBERICA SLInactiveFENOFIBRATE

DMF 232502009

SMRUTHI ORGANICS LTDInactiveFENOFIBRATE USP

DMF 239402010

DK PHARMA CHEM PVT LTDInactiveFENOFIBRATE USP

DMF 250342011

FINORGA SASInactiveFENOFIBRATE

DMF 254742011

D K PHARMACHEM PVT LTDInactiveFENOFIBRATE USP (PROCESS B)

DMF 279772014

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 24, 2000	SUPPL -5	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 100MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 31, 1993

No patent or exclusivity listings for this strength.

#002 — 67MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Feb 9, 1998

#003 — 134MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jun 30, 1999

#004 — 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jun 30, 1999