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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

Suppliers: see list8

Pharmacology for Tradename: ARICEPT

Clinical Trials for: ARICEPT

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eisai Inc
donepezil hydrochloride
TABLET, ORALLY DISINTEGRATING; ORAL021720Oct 18, 2004RXYes7,727,548<disabled>Y<disabled>
Eisai Inc
donepezil hydrochloride
TABLET; ORAL020690Nov 25, 1996RXNo6,140,321<disabled><disabled>
Eisai Inc
donepezil hydrochloride
TABLET; ORAL020690Nov 25, 1996RXNo6,372,760<disabled>Y<disabled>
Eisai Inc
donepezil hydrochloride
SOLUTION; ORAL021719Oct 18, 2004DISCNNo<disabled><disabled>
Eisai Inc
donepezil hydrochloride
TABLET; ORAL020690Nov 25, 1996RXNo6,245,911<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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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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