Viewing data from:

ZETIA

NDA

EZETIMIBE | N021445 | ORGANON LLC A SUB OF ORGANON AND CO

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Expired (1)TodayPED (+6 mo)

2026

Today

7612058

Apr. 30, 2026

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

262 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 214 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Randomized Controlled Trial of Moderate-Intensity Rosuvastatin With Ezetimibe Combination Therapy Versus High-Intensity Rosuvastatin on Progression of Coronary Atherosclerotic Plaque NCT03169985	Phase 4	Active	Samsung Medical Center	280	2017-07-12 → 2027-01-28
Assessment of the Effects of Long-term Lipid-lowering Therapy in Patients With Primary STEMI or NSTEMI NCT04347434	Phase 4	Recruiting	Penza State University	300	2020-02-12 → 2027-12-30
Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2 NCT01763827	Phase 3	Completed	Amgen	615	2013-01-21 → 2013-10-29
CKD-391 Pharmacokinetic Study Phase I NCT02501200	Phase 1	Completed	Chong Kun Dang Pharmaceutical	46	2015-08 → 2015-12
Randomized Trial Comparing Colesevelam vs. Ezetimibe NCT02682680	Phase 4	Completed	LMC Diabetes & Endocrinology Ltd.	200	2016-01-11 → 2017-05-25
A Controlled-Study of Fenofibrate 145 mg and Ezetimibe 10 mg in Type IIb Dyslipidemic Patients With Features of the Metabolic Syndrome NCT00349284	Phase 3	Completed	Solvay Pharmaceuticals	181	2005-01
Ezetimibe and Atorvastatin vs. Atorvastatin in Patients Age 65 and Older at High Risk for Coronary Heart Disease (CHD)(0653-112)NCT00418834	Phase 3	Completed	Organon and Co	1,053	2007-01 → 2008-10
Treatment of HDL to Reduce the Incidence of Vascular Events HPS2-THRIVE NCT00461630	Phase 3	Completed	University of Oxford	25,673	2007-01 → 2012-10
Plaque REgression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by IntraVascular UltraSound NCT01043380	Phase 4	Completed	Kumamoto University	245	2010-01 → 2014-09
To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 40 mg (0653-090)NCT00276484	Phase 3	Completed	Organon and Co	579	2006-02 → 2008-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$13.98

per ea

Lowest NADAC/Unit

$13.98

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
78206017801ZETIA 10 MG TABLET	$13.98	EA	Brand	$0.0691	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$298.95

Highest Price

$410.46

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
78206-0178-01ZETIA 10MG TAB	$410.46	FSS	Organon LLC	01/14/2027
78206-0178-01ZETIA 10MG TAB	$298.95	Big4	Organon LLC	01/14/2027

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

Medicare Part D Spending

CMS annual spending data for Zetia (2024)

Total Spending

$5.8M

Total Claims

7,124

Beneficiaries

1,813

Avg Cost/Unit

$12.44

Spending Trend

$2.3M(2021)→$7.0M(2022)→$6.7M(2023)→$5.8M(2024)

YoY Change:-4.7%

5yr CAGR:+3.4%

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

API Supply Chain33 active DMFs4 inactive

21 active API suppliers hold Drug Master Files for this ingredient.

ALIVUS LIFE SCIENCES LTDEZETIMIBE (PROCESS I)

DMF 197172006

TAPI NL BVEZETIMIBE

DMF 200392006

MSN LABORATORIES PRIVATE LTDEZETIMIBE USP [ROUTE CODE - EB]

DMF 215542008

CHANGZHOU PHARMACEUTICAL FACTORYEZETIMIBE

DMF 245112010

ALIVUS LIFE SCIENCES LTDEZETIMIBE, USP (PROCESS II)

DMF 248252011

NEULAND LABORATORIES LTDEZETIMIBE USP (FORM-X)

DMF 255432011

MATRIX PHARMACORP PRIVATE LTDEZETIMIBE USP

DMF 256532011

TAPI NL BVEZETIMIBE DRUG SUBSTANCE

DMF 260682012

MSN LABORATORIES PRIVATE LTDEZETIMIBE USP [ROUTE CODE - EZ]

DMF 269722013

ALIVUS LIFE SCIENCES LTDEZETIMIBE USP (PROCESS III)

DMF 273032013

DR REDDYS LABORATORIES LTDEZETIMIBE USP

DMF 278962014

LUPIN LTDEZETIMIBE USP (PROCESS-B)

DMF 281732014

MSN LABORATORIES PRIVATE LTDEZETIMIBE USP [ROUTE CODE "EE"]

DMF 291322015

HETERO LABS LTDEZETIMIBE

DMF 291582015

WUHAN ZY PHARMACEUTICAL CO LTDEZETIMIBE

DMF 296222015

HETERO LABS LTDEZETIMIBE (FORM-B)

DMF 298822015

LUPIN LTDEZETIMIBE USP (PROCESS-C)

DMF 303782016

APITORIA PHARMA PRIVATE LTDEZETIMIBE USP

DMF 308012016

MACLEODS PHARMACEUTICALS LTDEZETIMIBE

DMF 309812016

RAKS PHARMA PVT LTDEZETIMIBE USP

DMF 310822016

ZHEJIANG TIANYU PHARMACEUTICAL CO LTDEZETIMIBE

DMF 327162021

CHANGZHOU PHARMACEUTICAL FACTORYEZETIMIBE (ROUTE CODE: ZT)

DMF 359632021

APITORIA PHARMA PRIVATE LTDEZETIMIBE USP (PROCESS-II)

DMF 373682022

SAPTAGIR LABORATORIES PRIVATE LTDEZETIMIBE USP

DMF 375222022

MICRO LABS LTDEZETIMIBE USP

DMF 377282022

SAPTAGIR LABORATORIES PRIVATE LTDEZETIMIBE SILYLATED DIOL INTERMEDIATE (INTERMEDIATE OF EZETIMIBE)

DMF 380142023

DR REDDYS LABORATORIES LTDEZETIMIBE

DMF 392752023

SYMED LABS LTDEZETIMIBE USP

DMF 393392024

ZHEJIANG JINGSHENG PHARMACEUTICAL CO LTDEZETIMIBE

DMF 394102024

ALKEM LABORATORIES LTDEZETIMIBE USP

DMF 399342024

SYNTHIMED LABS PRIVATE LTDEZETIMIBE USP

DMF 408852025

SHOBHA LIFE SCIENCES PRIVATE LIMITEDEZETIMIBE USP

DMF 419142025

SYMED LABS LTDEZETIMIBE USP

DMF 433672026

NEULAND LABORATORIES LTDInactiveEZETIMIBE (FORM-X)

DMF 225732009

LUPIN LTDInactiveEZETIMIBE

DMF 235412010

SIGNA SA DE CVInactiveEZETIMIBE USP

DMF 266372012

WATERSTONE PHARMACEUTICALS (HUBEI) CO LTDInactiveEZETIMIBE

DMF 289422014

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

25 letters from Drugs@FDA

Date	Submission	Document
Feb 22, 2024	SUPPL -43	View Letter (PDF)
Jul 21, 2023	SUPPL -42	View Letter (PDF)
Aug 9, 2021	SUPPL -40	View Letter (PDF)
Oct 14, 2014	SUPPL -37	View Letter (PDF)
Jan 30, 2012	SUPPL -33	View Letter (PDF)
Aug 12, 2011	SUPPL -30	View Letter (PDF)
Nov 25, 2009	SUPPL -26	View Letter (PDF)
Nov 25, 2009	SUPPL -27	View Letter (PDF)
Feb 4, 2009	SUPPL -25	View Letter (PDF)
Jun 9, 2008	SUPPL -20	View Letter (PDF)
Jun 9, 2008	SUPPL -21	View Letter (PDF)
Feb 13, 2008	SUPPL -19	View Letter (PDF)
Jan 9, 2008	SUPPL -18	View Letter (PDF)
Nov 6, 2006	SUPPL -16	View Letter (PDF)
May 25, 2006	SUPPL -13	View Letter (PDF)
Mar 23, 2006	SUPPL -15	View Letter (PDF)
Mar 23, 2006	SUPPL -12	View Letter (PDF)
Jan 30, 2006	SUPPL -14	View Letter (PDF)
Mar 29, 2005	SUPPL -11	View Letter (PDF)
Mar 10, 2005	SUPPL -7	View Letter (PDF)
Sep 27, 2004	SUPPL -6	View Letter (PDF)
Jul 28, 2004	SUPPL -4	View Letter (PDF)
Jul 28, 2004	SUPPL -1	View Letter (PDF)
Jul 28, 2004	SUPPL -3	View Letter (PDF)
Oct 25, 2002	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG

RLDAB

1 patent0 exclusivities▴

TABLET;ORAL | Approved: Oct 25, 2002

Patents (1) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7612058	Oct 30, 2025PED: Apr 30, 2026	PED	—	—		—