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

88 trials from ClinicalTrials.gov — 6 recruiting, 1 active, 64 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Evaluate the Effect of Obicetrapib/Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome NCT07219602	Phase 3	Active	NewAmsterdam Pharma	300	2025-12-11 → 2028-06
Ezetimibe for Arrhythmia Recurrence After AF Ablation NCT07752758	Phase 4	Not Yet Recruiting	Second Affiliated Hospital, Zhejiang University, School of Medicine	120	2026-08-15 → 2028-06-30
LDL Cholesterol Reduction Following Ezetimibe Initiation NCT07839741	Phase 4	Recruiting	Universidade do Porto	100	2025-06-01 → 2027-04
Early Triple Lipid-Lowering Therapy With Bempedoic Acid After Acute Coronary Syndrome NCT07824323	Phase 4	Recruiting	Taipei Medical University Hospital	400	2026-08-26 → 2028-12
Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma NCT07704918	N/A	Recruiting	University of Colorado, Denver	40	2026-10-19 → 2028-12
Optimal Target Low-density Lipoprotein Cholesterol Level for Small Vessel Occlusion Stroke NCT06649240	N/A	Recruiting	Seoul National University Hospital	4,016	2024-10-04 → 2030-09
Ezetimibe Utilization Early After Acute Myocardial Infarction, "EzAMI Trial"NCT04701242	N/A	Recruiting	Cairo University	500	2021-03-24 → 2026-12
Ezetimibe Added to Statin Therapy (EASY) Study (0653-087)(COMPLETED)NCT00395473	Phase 3	Completed	Organon and Co	141	2005-03 → 2005-11
Ezetimibe Plus Atorvastatin Versus Atorvastatin Alone in Subjects With Primary Hypercholesterolemia (Study P03406)NCT00651404	Phase 3	Completed	Organon and Co	137	2004-01 → 2004-12
MD Ezetimibe Cyclosporine Interaction (0653-057)NCT00653276	Phase 1	Completed	Organon and Co	13	2003-11 → 2004-01

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 1 NDC

Highest NADAC/Unit

$13.94

per ea

Lowest NADAC/Unit

$13.94

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
78206017801ZETIA 10 MG TABLET	$13.94	EA	Brand	$0.0704	2026-10-21

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	$298.95	Big4	Organon LLC	01/14/2027
78206-0178-01ZETIA 10MG TAB	$410.46	FSS	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 Chain32 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

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

2 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 25, 2002

Patents (2)

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