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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 eight suppliers. 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 drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the donepezil hydrochloride profile page.

Summary for NDA: 022568

Eisai Inc
donepezil hydrochloride
Therapeutic Class:Antidementia Agents

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
donepezil hydrochloride
TABLET;ORAL 022568 NDA Eisai Inc. 62856-247 62856-247-30 30 TABLET, FILM COATED in 1 BOTTLE (62856-247-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength23MG
Approval Date:Jul 23, 2010TE:ABRLD:Yes
Patent:8,481,565Patent Expiration:Oct 4, 2026Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022568

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc
donepezil hydrochloride
TABLET;ORAL022568-001Jul 23, 20104,895,841<disabled>
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