Ezetimibe; Simvastatin

Lowers the risk of total mortality. Sold as Vytorin. Every FDA application for this active ingredient: 1 branded and 9 generic.

As of Nov 14, 2026, FDA lists 10 applications for Ezetimibe; Simvastatin (sold as Vytorin), first approved Jul 23, 2004, with 4 new uses approved and 0 published complete response letters.

First approved: Jul 23, 2004
Applications: 10
New uses approved: 4
Complete response letters: 0
Medicare spending, 2025: $21.2M

Medicare Spending

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


Ezetimibe-Simvastatin	Part D	$17.5M	-26%	70,087
Vytorin	Part D	$3.7M	-13%	1,010

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

EZETIMIBE-SIMVASTATIN 10-10 MG: $0.265 per unitGeneric · -17% in a year
EZETIMIBE-SIMVASTATIN 10-20 MG: $0.185 per unitGeneric · -48% in a year
EZETIMIBE-SIMVASTATIN 10-40 MG: $0.190 per unitGeneric · -58% in a year
EZETIMIBE-SIMVASTATIN 10-80 MG: $0.273 per unitGeneric · -39% in a year
VYTORIN 10-20 MG TABLET: $13.62 per unitBrand · +3% in a year
VYTORIN 10-40 MG TABLET: $13.79 per unitBrand · +5% in a year

Clinical Trials

6 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
Aggressive Lipid Lowering Therapy in ICI-Treated MelanomaMelanoma · University of Colorado, Denver	Not applicable	Recruiting	Jul 15, 2026
Early Statin-Ezetimibe Combination vs. Statin Monotherapy in Stroke With AtherosclerosisIschemic Stroke, Hypercholesteremia · Chang Gung Memorial Hospital	Phase 2	Recruiting	Dec 29, 2025
Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in RussiaAtherosclerotic Cardiovascular Disease · Novartis Pharmaceuticals	—	Recruiting	Mar 5, 2025
LATAM LOWERS LDL-CHypercholesterolaemia · Novartis Pharmaceuticals	Phase 4	Recruiting	Jul 15, 2024
Intensive Cholesterol-Lowering and CD8+ T Cells in Prostate CancerProstate Cancer · Cedars-Sinai Medical Center	Phase 2	Recruiting	May 31, 2024

Applications

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


Jul 23, 2004	VytorinNDA 21687 · New combination	Organon	43	Marketed
Apr 26, 2017	Ezetimibe And SimvastatinANDA 200909	Dr Reddys Labs SA	2	Marketed
Apr 26, 2017	Ezetimibe And SimvastatinANDA 201890	Ani Pharms	6	Discontinued
Apr 26, 2017	Ezetimibe And SimvastatinANDA 202968	Watson Labs Inc	5	Discontinued
Nov 21, 2017	Ezetimibe And SimvastatinANDA 208831	Amneal Pharms Co	6	Discontinued
Dec 22, 2017	Ezetimibe And SimvastatinANDA 209222	Alkem Labs Ltd	6	Marketed
Jun 27, 2019	Ezetimibe And SimvastatinANDA 208699	Glenmark Pharms Ltd	4	Marketed
Dec 17, 2020	Ezetimibe And SimvastatinANDA 200082	Aurobindo Pharma USA	1	Marketed
Dec 10, 2024	Ezetimibe And SimvastatinANDA 211663	Sciegen Pharms	0	Discontinued
Jan 27, 2025	Ezetimibe And SimvastatinANDA 209461	Torrent	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