Gemfibrozil

Sold as Lopid. Every FDA application for this active ingredient: 1 branded and 20 generic.

As of Nov 13, 2026, FDA lists 21 applications for Gemfibrozil (sold as Lopid), first approved Dec 21, 1981, with 1 new use approved and 0 published complete response letters.

First approved: Dec 21, 1981
Applications: 21
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $13.4M

Medicare Spending

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


Gemfibrozil	Part D	$13.4M	-5%	170,520
Lopid	Part D	$5K	+98%	0

Orphan Designations (FDA)

3 designations, 0 approved for the designated use; see all orphan designations

Treatment of Krabbe DiseasePolaryx Therapeutics, Inc. · designated Aug 30, 2021
Treatment of GM2 gangliosidosesPolaryx Therapeutics, Inc. · designated Aug 27, 2021
Treatment of neuronal ceroid lipofuscinosesPolaryx Therapeutics, Inc. · designated Aug 2, 2017

Clinical Trials

2 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
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of PLX-200 in Pediatric Patients (Master Protocol)Lysosomal Storage Disorders, Sandhoff Disease · Polaryx Therapeutics, Inc.	Phase 2	Not yet recruiting	Jul 31, 2026

Applications

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


Dec 21, 1981	LopidNDA 18422 · New molecular entity	Pfizer Pharms	43	Marketed
Jan 25, 1993	GemfibrozilANDA 73466	Natco	1	Discontinued
Sep 27, 1993	GemfibrozilANDA 74270	Chartwell Molecules	9	Marketed
Oct 31, 1993	GemfibrozilANDA 74256	Teva	21	Discontinued
Feb 16, 1995	GemfibrozilANDA 74452	Pharmobedient	2	Discontinued
Apr 28, 1995	GemfibrozilANDA 74442	Watson Labs	9	Discontinued
Sep 29, 1995	GemfibrozilANDA 74615	Chartwell Rx	5	Discontinued
Jul 20, 1998	GemfibrozilANDA 75034	Apotex	14	Discontinued
Jul 27, 2006	GemfibrozilANDA 77836	Invagen Pharms	7	Marketed
Mar 26, 2007	GemfibrozilANDA 78012	Epic Pharma LLC	7	Marketed
Jun 1, 2007	GemfibrozilANDA 78207	Impax Pharms	3	Marketed
Dec 29, 2008	GemfibrozilANDA 79239	Sun Pharm Inds Inc	4	Discontinued
Aug 16, 2010	GemfibrozilANDA 78599	Hikma Pharms	3	Discontinued
Sep 13, 2010	GemfibrozilANDA 79072	Northstar Hlthcare	8	Marketed
Sep 16, 2015	GemfibrozilANDA 202726	Aurobindo Pharma Ltd	4	Marketed
Jun 17, 2016	GemfibrozilANDA 203266	Cadila Pharms Ltd	3	Marketed
Aug 28, 2018	GemfibrozilANDA 204189	Cadila	1	Discontinued
Jan 13, 2021	GemfibrozilANDA 214603	Ascent Pharms Inc	0	Marketed
—	GemfibrozilANDA 72929	Purepac Pharm	0	Discontinued
—	GemfibrozilANDA 74156	Watson Labs	0	Discontinued
—	GemfibrozilANDA 74360	Purepac Pharm	0	Discontinued

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