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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.

This drug has one hundred and twenty-seven patent family members in thirty-two countries.

The generic ingredient in ARICEPT is donepezil hydrochloride. There are thirty 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)

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

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

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

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

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

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

A Plan on Investigation and Collection of Aricept Safety Information With a Dose Increase on Alzheimer's Disease Patients
Status: Recruiting Condition: Alzheimer's Disease

Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10
Status: Terminated Condition: Down Syndrome; Cognitive Dysfunction

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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
SOLUTION; ORAL021719-001Oct 18, 2004DISCNNo<disabled><disabled>
Eisai Inc
ARICEPT ODT
donepezil hydrochloride
TABLET, ORALLY DISINTEGRATING; ORAL021720-001Oct 18, 2004RXNo7,727,548<disabled>Y<disabled>
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET; ORAL022568-001Jul 23, 2010RXYes4,895,841<disabled>YY<disabled>
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET; ORAL020690-001Nov 25, 1996RXYes6,245,911<disabled><disabled>
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET; ORAL020690-002Nov 25, 1996RXNo6,140,321<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

International Patent Family for Tradename: ARICEPT

Country Document Number Publication Date
Hungary211144Oct 30, 1995
Germany69913138Jan 08, 2004
Germany69913138Aug 26, 2004
Denmark175717Jan 31, 2005
Finland95572Feb 26, 1996
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2015 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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