Fenofibrate

Sold as Lipidil, Tricor, Triglide, Lipofen, Antara and 1 more. Every FDA application for this active ingredient: 7 branded and 48 generic.

As of Nov 13, 2026, FDA lists 55 applications for Fenofibrate (sold as Lipidil, Tricor, Triglide and others), first approved Dec 31, 1993, with 2 new uses approved and 0 published complete response letters.

First approved: Dec 31, 1993
Applications: 55
New uses approved: 2
Complete response letters: 0
Medicare spending, 2025: $128M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Fenofibrate	Part D	$127M	-2%	1,172,418
Lipofen	Part D	$117K	-30%	58

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Lipidil, new approvalDrugs in new dosage forms and with new dosages indicated for the treatment of hyperlipemia (including familial hyperlipemia). · Abbott Japan Co., Ltd. · Mar 30, 2011

Clinical Trials

25 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney DiseaseDiabetic Kidney Disease (DKD), Type 2 Diabetes · Beijing University of Chinese Medicine	Phase 2	Active, not recruiting	Oct 30, 2026
Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In NeonatesJaundice, Neonatal · Rubab Fatima	Phase 4	Not yet recruiting	Aug 19, 2026
Bacillus Subtilis and Enterococcus Faecium Probiotic Plus Lipid-Lowering Therapy for Hypertriglyceridemic Acute Pancreatitis: A Prospective RCTHypertriglyceridemic Acute Pancreatitis, Acute Pancreatitis, Hypertriglyceridemia-induced · Jianyin Zhou	Phase 4	Recruiting	Jul 22, 2026
Clinical Study Evaluating the Efficacy and Safety of Fenofibrates Versus Silymarin in Adult Patients With SepsisSepsis · Tanta University	Phase 2	Not yet recruiting	May 7, 2026
FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC TherapyPrimary Biliary Cholangitis (PBC) · Xijing Hospital of Digestive Diseases	Phase 3	Recruiting	Dec 22, 2025
Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)Primary Biliary Cholangitis (PBC) · Xijing Hospital of Digestive Diseases	Early phase 1	Active, not recruiting	Aug 5, 2025
Fenofibrate Role in the Prophylaxis From Peripheral Neuropathy Induced by Bortezomib, Lenalidomide and Dexamethasone (VRd) Protocol in the Treatment of Patients With Multiple Myeloma (MM)Peripheral Neuropathy, Multiple Myeloma, Neoplasms · Tanta University	Phase 4	Recruiting	Jun 17, 2025
Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver TransplantationPrimary Sclerosing Cholangitis, Liver Transplant, Complications · Mayo Clinic	Phase 2	Recruiting	Apr 1, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Dec 31, 1993	Lipidil, TricorNDA 19304 · New molecular entity	Abbvie	6	Discontinued
Sep 4, 2001	TricorNDA 21203 · New dosage form	Abbvie	5	Discontinued
Apr 9, 2002	FenofibrateANDA 75753	Rhodes Pharms	8	Discontinued
Oct 27, 2003	FenofibrateANDA 75868	Impax Labs	3	Discontinued
Nov 5, 2004	TricorNDA 21656 · New formulation or manufacturer	Abbvie	14	Discontinued
Nov 30, 2004	AntaraNDA 21695 · New dosage form	Lupin	17	Marketed
May 7, 2005	TriglideNDA 21350 · New dosage form	Jagotec	11	Discontinued
May 13, 2005	FenofibrateANDA 76433	Rhodes Pharms	4	Marketed
Oct 31, 2005	FenofibrateANDA 76635	Sun Pharm Inds Ltd	5	Marketed
Dec 29, 2005	FenofibrateANDA 76520	Mylan	12	Discontinued
Jan 11, 2006	LipofenNDA 21612 · New dosage form	Cipher Pharms Inc	12	Marketed
Aug 10, 2007	FenoglideNDA 22118 · New formulation or manufacturer	Salix	8	Discontinued
Mar 26, 2008	FenofibrateANDA 76509	Impax Labs	7	Marketed
Dec 23, 2011	FenofibrateANDA 90856	Lupin Ltd	5	Marketed
Mar 1, 2012	FenofibrateANDA 90859	Chartwell Rx	1	Marketed
Apr 5, 2012	FenofibrateANDA 90715	Bausch	3	Discontinued
Oct 23, 2012	FenofibrateANDA 202676	Rising	3	Discontinued
Dec 7, 2012	FenofibrateANDA 202856	Mylan Pharms Inc	3	Marketed
Jan 10, 2013	FenofibrateANDA 202579	Pharmobedient	4	Discontinued
Jul 26, 2013	FenofibrateANDA 202252	Apotex	6	Marketed
Oct 31, 2014	FenofibrateANDA 201748	Sun Pharm Inds Ltd	7	Discontinued
Aug 17, 2015	FenofibrateANDA 204019	Lupin	4	Marketed
May 5, 2016	FenofibrateANDA 205118	Aurobindo Pharma	4	Marketed
Jun 23, 2016	FenofibrateANDA 204475	Mylan Pharms Inc	4	Marketed
Jul 12, 2016	FenofibrateANDA 204598	Hetero Labs Ltd Iii	2	Marketed
Dec 15, 2016	FenofibrateANDA 208709	Cipla	5	Marketed
Mar 28, 2017	FenofibrateANDA 207378	Invagen Pharms	3	Discontinued
Apr 7, 2017	FenofibrateANDA 205566	Glenmark Pharms Ltd	3	Marketed
Sep 7, 2017	FenofibrateANDA 200884	Sun Pharm	0	Discontinued
Nov 16, 2017	FenofibrateANDA 207805	Reyoung	3	Marketed
Dec 19, 2017	FenofibrateANDA 207803	Bostal	1	Marketed
Feb 9, 2018	FenofibrateANDA 209951	Amneal	5	Marketed
Mar 19, 2018	FenofibrateANDA 209950	Amneal	4	Marketed
Apr 30, 2018	FenofibrateANDA 209504	Ani Pharms	3	Marketed
Jun 26, 2018	FenofibrateANDA 210782	Torrent	2	Marketed
Jul 20, 2018	FenofibrateANDA 210138	Ajanta Pharma Ltd	3	Marketed
Aug 17, 2018	FenofibrateANDA 210606	Rising	4	Marketed
Aug 28, 2018	FenofibrateANDA 211080	Prinston	2	Marketed
Sep 10, 2018	FenofibrateANDA 210705	Ajanta Pharma Ltd	2	Marketed
Feb 11, 2019	FenofibrateANDA 209660	Chartwell Rx	1	Marketed
Apr 19, 2019	FenofibrateANDA 207564	Ingenus Pharms LLC	2	Discontinued
Aug 9, 2019	FenofibrateANDA 210476	Alembic	2	Marketed
Sep 6, 2019	FenofibrateANDA 210670	Dr Reddys	1	Marketed
Jan 17, 2020	FenofibrateANDA 213252	Alembic	1	Discontinued
Mar 18, 2020	FenofibrateANDA 211122	Rising	2	Marketed
Jun 12, 2020	FenofibrateANDA 213864	Mankind Pharma	1	Marketed
Oct 19, 2020	FenofibrateANDA 213842	Alembic	1	Marketed
Feb 10, 2021	FenofibrateANDA 208476	Bostal	2	Marketed
Sep 20, 2021	FenofibrateANDA 212232	Aurobindo Pharma Ltd	0	Marketed
Sep 27, 2022	FenofibrateANDA 216798	Aurobindo Pharma	0	Marketed
Sep 7, 2023	FenofibrateANDA 217732	Creekwood Pharms	1	Marketed
Jan 31, 2024	FenofibrateANDA 211407	Chartwell	0	Marketed
Apr 24, 2024	FenofibrateANDA 218548	Yichang Humanwell	0	Marketed
Nov 13, 2024	FenofibrateANDA 210248	Macleods Pharms	0	Marketed
Jan 21, 2026	FenofibrateANDA 210379	Macleods Pharms	0	Marketed

Show all 55

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA