Orange Book product · Brand (NDA)

ARICEPT

DONEPEZIL HYDROCHLORIDE

Brand (NDA)NDA 022568TE ABRX EISAI INC

Jul 23, 2010

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 23, 2010
16 yr 2 mo ago
Today
Patent 8481565 expires
Listed drug product patent expiration.
Oct 04, 2026
in 4 mo

Active ingredient

DONEPEZIL HYDROCHLORIDE

Strength

23MG

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 022568

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
8481565	Oct 04, 2026	in 4 mo	Product