Orange Book product · Brand (NDA)

ZETIA

EZETIMIBE

Brand (NDA)NDA 021445TE ABRX ORGANON

Oct 25, 2002

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 25, 2002
24 yr ago
Patent 7612058 expires
Listed method-of-use patent (U-1173) expiration.
Oct 30, 2025
8 mo ago
Patent 7612058 expires
Listed method-of-use patent (U-1027) expiration.
Oct 30, 2025
8 mo ago
Patent 7612058*PED expires
Listed listed patent expiration.
Apr 30, 2026
2 mo ago
Today

Active ingredient

EZETIMIBE

Strength

10MG

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 021445

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7612058	Oct 30, 2025	8 mo ago	U-1173
7612058	Oct 30, 2025	8 mo ago	U-1027
7612058*PED	Apr 30, 2026	2 mo ago