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Generated: November 14, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020690

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NDA 020690 describes ARICEPT, which is a drug marketed by Eisai Inc and is included in four NDAs. It is available from four 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-two drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.
Summary for 020690
Tradename:ARICEPT
Applicant:Eisai Inc
Ingredient:donepezil hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020690
Mechanism of ActionCholinesterase Inhibitors
Suppliers and Packaging for NDA: 020690
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARICEPT donepezil hydrochloride TABLET;ORAL 020690 NDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7623 0615-7623-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7623-39)
ARICEPT donepezil hydrochloride TABLET;ORAL 020690 NDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7624 0615-7624-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7624-39)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 25, 1996TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 25, 1996TE:ABRLD:Yes

Expired US Patents for NDA 020690

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996 ➤ Sign Up ➤ Sign Up
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-001 Nov 25, 1996 ➤ Sign Up ➤ Sign Up
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-001 Nov 25, 1996 ➤ Sign Up ➤ Sign Up
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996 ➤ Sign Up ➤ Sign Up
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996 ➤ Sign Up ➤ Sign Up
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-001 Nov 25, 1996 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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