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FENOGLIDE

NDA

FENOFIBRATE | N022118 | SALIX PHARMACEUTICALS INC

2 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Foley & Lardner, LLP FDA-2026-P-0655 · 4 docket documents Foley & Lardner LLP filed this citizen petition under 21 C.F.R. § 10.25(a), 10.30, and 314.161 requesting that the FDA determine whether the reference listed drug FENOGLIDE® (fenofibrate) Tablets 40 mg and 120 mg, NDA# 022118, held by Salix Pharmaceuticals Inc., was discontinued for safety or effect	505(q)	2026-01-21	Granted	Foley & Lardner, LLP

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

9 letters from Drugs@FDA

Date	Submission	Document
Jun 9, 2025	SUPPL -14	View Letter (PDF)
Jun 7, 2021	SUPPL -13	View Letter (PDF)
May 16, 2019	SUPPL -10	View Letter (PDF)
Mar 14, 2019	SUPPL -9	View Letter (PDF)
May 21, 2018	SUPPL -7	View Letter (PDF)
Nov 6, 2012	SUPPL -5	View Letter (PDF)
Mar 14, 2012	SUPPL -3	View Letter (PDF)
Mar 5, 2008	SUPPL -1	View Letter (PDF)
Aug 14, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 10, 2007

No patent or exclusivity listings for this strength.

#002 — 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 10, 2007