Details for New Drug Application (NDA): 022568

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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

Tradename:	ARICEPT
Applicant:	Eisai Inc
Ingredient:	donepezil hydrochloride
Patents:	1

Pharmacology for NDA: 022568

Mechanism of Action	Cholinesterase 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:	RX	Dosage:	TABLET;ORAL			Strength	23MG
Approval Date:	Jul 23, 2010	TE:	AB	RLD:	Yes
Patent:	8,481,565	Patent Expiration:	Oct 4, 2026	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022568

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	022568-001	Jul 23, 2010	4,895,841	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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