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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Novartis
McKinsey
Chinese Patent Office
Cerilliant
Teva
QuintilesIMS
Daiichi Sankyo
Healthtrust
Baxter

Generated: February 17, 2018

DrugPatentWatch Database Preview

ARICEPT Drug Profile

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When do Aricept patents expire, and what generic alternatives are available?

Aricept is a drug marketed by Eisai Inc and is included in four NDAs. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has thirty-six patent family members in fifteen countries.

The generic ingredient in ARICEPT is donepezil hydrochloride. There are thirty-one drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.
Drug patent expirations by year for ARICEPT
Pharmacology for ARICEPT

US Patents and Regulatory Information for ARICEPT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eisai Inc ARICEPT donepezil hydrochloride SOLUTION;ORAL 021719-001 Oct 18, 2004 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 022568-001 Jul 23, 2010 AB RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-001 Nov 25, 1996 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-002 Oct 18, 2004 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-001 Oct 18, 2004 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for ARICEPT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 020690-001 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 022568-001 Jul 23, 2010 ➤ 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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Paragraph IV (Patent) Challenges for ARICEPT
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 23 mg ➤ Subscribe 7/9/2013
➤ Subscribe Orally Disintegrating Tablets 5 mg and 10 mg ➤ Subscribe 6/30/2010

Non-Orange Book US Patents for ARICEPT

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,507,527 Method for stabilizing anti-dementia drug ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for ARICEPT

Supplementary Protection Certificates for ARICEPT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1998 Austria ➤ Sign Up PRODUCT NAME: DONEPEZIL UND SEINE PHARMAKOLOGISCH ANNEHMBAREN SALZE, INSBESONDERE DONEPEZIL HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-22056, 1-22057 19970728; FIRST REGISTRATION: GB PL105550006, PL105550007 19970214
C/GB97/023 United Kingdom ➤ Sign Up PRODUCT NAME: DONEPEZIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE HYDROCHLORIDE; REGISTERED: UK PL 10555/0006 19970214; UK PL 10555/0007 19970214
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Cipla
Express Scripts
Daiichi Sankyo
McKesson
Teva
Dow
US Department of Justice
Argus Health

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