Viewing data from:

VYTORIN

NDA

EZETIMIBE; SIMVASTATIN | N021687 | ORGANON LLC A SUB OF ORGANON AND CO

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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps, & McNamara P.C. FDA-2026-P-5995 · 7 docket documents Hyman, Phelps & McNamara P.C. filed this suitability petition to request FDA evaluation regarding whether a particular drug product meets regulatory requirements for approval or designation under applicable FDA frameworks, though the specific drug name, therapeutic area, and detailed regulatory mech	Suitability	2026-05-28	Open	Hyman, Phelps, & McNamara P.C.

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

Clinical Trials

67 trials from ClinicalTrials.gov, 56 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED)NCT00092677	Phase 3	Completed	Organon and Co	1,873	2001-01 → 2008-04
Effects of Ezetimibe, Simvastatin, and Vytorin on Reducing L5 a Subfraction of LDL in Patients With Metabolic Syndrome.NCT00988364	Phase 4	Completed	Baylor College of Medicine	30	2007-03 → 2008-02
A Study to Evaluate an Investigational Drug in Patients With Mixed Hyperlipidemia (0653A-071)(COMPLETED)NCT00093899	Phase 3	Completed	Organon and Co	611	2004-11 → 2005-09
MK0653A (Ezetimibe (+) Simvastatin) Compared to an Approved Drug (Atorvastatin) for the Treatment of High Cholesterol (0653A-051)(COMPLETED)NCT00092690	Phase 3	Completed	Organon and Co	1,902	2003-06 → 2004-03
EASEGO Study: Doubling of Atorvastatin/Simvastatin or INEGY in Patients With Hypercholesterolemia and Coronary Artery Disease(CAD)(0653A-089)NCT00166530	Phase 4	Completed	Organon and Co	367	2005-11 → 2007-02
To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)NCT00271817	Phase 3	Completed	Organon and Co	1,220	2005-12 → 2008-02
The Effects of Ezetimibe/Simvastatin 10/20 mg Versus Simvastatin 40 mg in High Cholesterol and Coronary Heart Disease Study (P04039AM2)(COMPLETED)NCT00423579	Phase 4	Completed	Organon and Co	120	2006-07-01 → 2008-03-01
Effects of Vytorin Versus Placebo in Subjects With Primary Hypercholesterolemia (Study P04420)NCT00413972	Phase 3	Completed	Organon and Co	392	2006-04 → 2006-11
Effects of Statin and Ezetimibe Association on Kinetics of Artificial Chilomicrons NCT00481351	Phase 4	Completed	University of Sao Paulo	25	2007-06 → 2010-01
Comprehensive Magnetic Resonance of Peripheral Arterial Disease NCT00587678	N/A	Completed	University of Virginia	85	2006-01 → 2009-10

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 4 NDCs

Highest NADAC/Unit

$13.80

per ea

Lowest NADAC/Unit

$13.62

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
78206017601VYTORIN 10-40 MG TABLET	$13.80	EA	Brand	$0.2368	2026-08-19
78206017602VYTORIN 10-40 MG TABLET	$13.80	EA	Brand	$0.2368	2026-08-19
78206017501VYTORIN 10-20 MG TABLET	$13.62	EA	Brand	$0.2278	2026-08-19
78206017502VYTORIN 10-20 MG TABLET	$13.62	EA	Brand	$0.2278	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 16 NDCs (8 FSS, 8 Big4)

Lowest Price

$294.43

Highest Price

$1219.72

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
78206-0174-01VYTORIN 10-10 TAB	$294.43	Big4	Organon LLC	01/14/2027
78206-0174-01VYTORIN 10-10 TAB	$406.53	FSS	Organon LLC	01/14/2027
78206-0174-02VYTORIN 10-10 TAB	$893.61	Big4	Organon LLC	01/14/2027
78206-0174-02VYTORIN 10-10 TAB	$1219.72	FSS	Organon LLC	01/14/2027
78206-0175-01VYTORIN 10-20 TAB	$296.21	Big4	Organon LLC	01/14/2027
78206-0175-01VYTORIN 10-20 TAB	$406.53	FSS	Organon LLC	01/14/2027

Showing 6 of 16 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Vytorin (2024)

Total Spending

$4.3M

Total Claims

5,246

Beneficiaries

1,203

Avg Cost/Unit

$12.40

Spending Trend

$1.8M(2021)→$5.6M(2022)→$5.0M(2023)→$4.3M(2024)

YoY Change:-3.3%

5yr CAGR:+4.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

41 letters from Drugs@FDA

Date	Submission	Document
Apr 1, 2024	SUPPL -66	View Letter (PDF)
Feb 9, 2024	SUPPL -61	View Letter (PDF)
Feb 9, 2024	SUPPL -65	View Letter (PDF)
Feb 9, 2024	SUPPL -64	View Letter (PDF)
Feb 9, 2024	SUPPL -61	View Letter (PDF)
Sep 28, 2020	SUPPL -63	View Letter (PDF)
Oct 9, 2019	SUPPL -62	View Letter (PDF)
Apr 4, 2019	SUPPL -52	View Letter (PDF)
Mar 1, 2018	SUPPL -60	View Letter (PDF)
Feb 3, 2015	SUPPL -53	View Letter (PDF)
Oct 14, 2014	SUPPL -51	View Letter (PDF)
Feb 28, 2014	SUPPL -50	View Letter (PDF)
Oct 28, 2013	SUPPL -48	View Letter (PDF)
Nov 6, 2012	SUPPL -46	View Letter (PDF)
Nov 6, 2012	SUPPL -47	View Letter (PDF)
Feb 29, 2012	SUPPL -44	View Letter (PDF)
Jan 30, 2012	SUPPL -39	View Letter (PDF)
Dec 5, 2011	SUPPL -42	View Letter (PDF)
Oct 12, 2011	SUPPL -41	View Letter (PDF)
Jun 8, 2011	SUPPL -40	View Letter (PDF)
Jun 8, 2011	SUPPL -33	View Letter (PDF)
Dec 28, 2010	SUPPL -37	View Letter (PDF)
Apr 28, 2010	SUPPL -36	View Letter (PDF)
Mar 18, 2010	SUPPL -34	View Letter (PDF)
Jan 21, 2010	SUPPL -32	View Letter (PDF)
Feb 3, 2009	SUPPL -30	View Letter (PDF)
Jan 12, 2009	SUPPL -29	View Letter (PDF)
Feb 14, 2008	SUPPL -22	View Letter (PDF)
Jan 9, 2008	SUPPL -21	View Letter (PDF)
May 29, 2007	SUPPL -19	View Letter (PDF)
Dec 4, 2006	SUPPL -16	View Letter (PDF)
Oct 26, 2006	SUPPL -10	View Letter (PDF)
Oct 5, 2006	SUPPL -11	View Letter (PDF)
Jul 13, 2006	SUPPL -15	View Letter (PDF)
Mar 23, 2006	SUPPL -6	View Letter (PDF)
Mar 23, 2006	SUPPL -13	View Letter (PDF)
Dec 15, 2005	SUPPL -9	View Letter (PDF)
Jun 7, 2005	SUPPL -3	View Letter (PDF)
Mar 10, 2005	SUPPL -2	View Letter (PDF)
Feb 17, 2005	SUPPL -1	View Letter (PDF)
Jul 28, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 10MG;10MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 23, 2004

No patent or exclusivity listings for this strength.

#002 — 10MG;20MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 23, 2004

#003 — 10MG;40MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 23, 2004

#004 — 10MG;80MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 23, 2004