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Profile for Tradename: ARICEPT

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Aricept is a drug marketed by Eisai Inc and is included in four NDAs. It is available from eight suppliers. There are three patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in ARICEPT is donepezil hydrochloride. There are twenty-nine drug master file entries for this compound. Eight suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the donepezil hydrochloride profile page.

Summary for Tradename: ARICEPT

Patents:7
Applicants:1
NDAs:4
Suppliers: see list8

Pharmacology for Tradename: ARICEPT

Clinical Trials for: ARICEPT

Aricept to Improve Functional Tasks in Vascular Dementia
Status: Active, not recruiting Condition: Stroke; Vascular Dementia; Memory Deficits

A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)
Status: Completed Condition: Dementia With Lewy Bodies (DLB)

Computerized Cognition Testing in Participants With Mild Alzheimer's Disease (AD) Treated With Donepezil (MK-0000-318)
Status: Recruiting Condition: Alzheimer's Disease

Pharmacokinetic Comparisons of Two Donepezil Formulations
Status: Completed Condition: Alzheimer Disease

Donepezil 10 mg Tablets Under Fed Conditions
Status: Completed Condition: Healthy

Donepezil 10 mg Tablets Under Fasting Conditions
Status: Completed Condition: Healthy

A Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia
Status: Completed Condition: Alzheimer's Type Dementia

A Bioequivalence Study Comparing Improved Versus Current Orally Disintegrating E2020 10 mg Tablet in Healthy Japanese Adult Males
Status: Completed Condition: Healthy Adult

Bioequivalence Study for Donepezil Hydrochloride Tablets 10 mg Under Fed Condition
Status: Completed Condition: Healthy

Bioequivalence Study for Donepezil Hydrochloride 10 mg Tablets Under Fasting Condition
Status: Completed Condition: Healthy

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET; ORAL020690Nov 25, 1996RXNo6,372,760<disabled>Y<disabled>
Eisai Inc
ARICEPT ODT
donepezil hydrochloride
TABLET, ORALLY DISINTEGRATING; ORAL021720Oct 18, 2004RXNo4,895,841<disabled>YY<disabled>
Eisai Inc
ARICEPT ODT
donepezil hydrochloride
TABLET, ORALLY DISINTEGRATING; ORAL021720Oct 18, 2004RXYes4,895,841<disabled>YY<disabled>
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET; ORAL020690Nov 25, 1996RXYes6,372,760<disabled>Y<disabled>
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET; ORAL020690Nov 25, 1996RXNo4,895,841<disabled><disabled>
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Paragraph IV activity for: ARICEPT

Drugname Dosage Strength RLD Submissiondate
donepezil hydrochlorideTablets23 mgAricept7/9/2013
donepezil hydrochlorideOrally Disintegrating Tablets5 mg and 10 mgAricept ODT6/30/2010
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