You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 12, 2025

Details for New Drug Application (NDA): 021445

✉ Email this page to a colleague

NDA 021445 describes ZETIA, which is a drug marketed by Organon and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the ZETIA profile page.

The generic ingredient in ZETIA is ezetimibe. There are twenty-four drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ezetimibe profile page.

Summary for 021445

Tradename:	ZETIA
Applicant:	Organon
Ingredient:	ezetimibe
Patents:	1

Pharmacology for NDA: 021445

Physiological Effect	Decreased Cholesterol Absorption

Medical Subject Heading (MeSH) Categories for 021445

Anticholesteremic Agents

Suppliers and Packaging for NDA: 021445

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZETIA	ezetimibe	TABLET;ORAL	021445	NDA	Organon LLC	78206-178	78206-178-01	30 TABLET in 1 BOTTLE (78206-178-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Oct 25, 2002	TE:	AB	RLD:	Yes
Patent:	7,612,058*PED	Patent Expiration:	Apr 30, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 021445

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	5,767,115	⤷ Get Started Free
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	RE37721*PED	⤷ Get Started Free
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	RE42461*PED	⤷ Get Started Free
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	7,030,106*PED	⤷ Get Started Free
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	5,846,966*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.