Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Harvard Business School

Last Updated: June 9, 2023

Details for New Drug Application (NDA): 022568

✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions

NDA 022568 describes ARICEPT, which is a drug marketed by Eisai Inc and is included in four NDAs. It is available from one supplier. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the ARICEPT profile page.

The generic ingredient in ARICEPT is donepezil hydrochloride. There are thirty-two drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.
Summary for 022568
Applicant:Eisai Inc
Ingredient:donepezil hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 022568
Mechanism of ActionCholinesterase Inhibitors
Suppliers and Packaging for NDA: 022568
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARICEPT donepezil hydrochloride TABLET;ORAL 022568 NDA Eisai Inc. 62856-247 62856-247-30 30 TABLET, FILM COATED in 1 BOTTLE (62856-247-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength23MG
Approval Date:Jul 23, 2010TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Oct 4, 2026Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
Harvard Business School

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. 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.