Drug facts

Molecule

Donepezil (Aricept)

Generics already compete: 19 makers on the market. 39 A-rated products from 19 makers substitute at the counter.

Aricept was first approved by the FDA on 11/25/1996 under NDA 020690; the application holder is Eisai Inc.

The latest NADAC for DONEPEZIL HCL 10 MG TABLET is $0.05 per unit (as of 10/28/2026).

Holder Eisai IncApplication NDA 020690Approved 11/25/1996

01Patents and exclusivity

When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.

Latest patent
No NDA 020690 patent listed in the Orange Book
Orange Book
Later patents, other products
Adlarity 08/11/2038; Aricept (NDA 022568) 10/04/2026
Orange Book

02Competition

Generics
19 generic makers
Orange Book
First generic approved
12/11/2009
Orange Book
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Donepezil profile.See what is included

03Supply and price

FDA drug shortage
ClearNot on the current shortage list
FDA shortages
NADAC
$0.05 per unitDONEPEZIL HCL 10 MG TABLET, mid-priced of 3 strengths, as of 10/28/2026
CMS NADAC
Latest recall
01/26/2022Class II, Donepezil Hydrochloride, Cardinal Healthcare
FDA enforcement

04Product

Application holder
Eisai Inc
Orange Book
Application
NDA 020690
Orange Book
First approved
11/25/1996
Orange Book
Dosage forms
tablet; tablet, orally disintegrating
Routes
oral

Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.