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Last Updated: April 13, 2024

ARICEPT Drug Patent 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 one Paragraph IV challenge.

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

The generic ingredient in ARICEPT is donepezil hydrochloride. There are thirty-two drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.

Summary for ARICEPT
Drug patent expirations by year for ARICEPT
Drug Prices for ARICEPT

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Drug Sales Revenue Trends for ARICEPT

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Recent Clinical Trials for ARICEPT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Vanderbilt University Medical CenterEarly Phase 1
G2GBio, Inc.Phase 1
Inventage Lab., Inc.Phase 1/Phase 2

See all ARICEPT clinical trials

Pharmacology for ARICEPT
Anatomical Therapeutic Chemical (ATC) Classes for ARICEPT
Paragraph IV (Patent) Challenges for ARICEPT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ARICEPT Tablets donepezil hydrochloride 23 mg 022568 2013-07-09

US Patents and Regulatory Information for ARICEPT

ARICEPT is protected by one US patents.

Patents protecting ARICEPT

Method for stabilizing anti-dementia drug
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 022568-001 Jul 23, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-001 Nov 25, 1996 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ARICEPT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996 ⤷  Try a Trial ⤷  Try a Trial
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 022568-001 Jul 23, 2010 ⤷  Try a Trial ⤷  Try a Trial
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-001 Nov 25, 1996 ⤷  Try a Trial ⤷  Try a Trial
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ARICEPT

See the table below for patents covering ARICEPT around the world.

Country Patent Number Title Estimated Expiration
South Korea 20070089207 MATRIX-TYPE CONTROLLED RELEASE PREPARATION COMPRISING BASIC SUBSTANCE OR SALT THEREOF, AND PROCESS FOR PRODUCTION OF THE SAME ⤷  Try a Trial
Japan H1053576 POLYMORPHIC CRYSTAL OF DONEPEZIL HYDROCHLORIDE AND ITS PRODUCTION ⤷  Try a Trial
Luxembourg 90221 ⤷  Try a Trial
Australia 2005320547 Method for stabilizing anti-dementia drug ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ARICEPT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0296560 98C0015 Belgium ⤷  Try a Trial PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21 303 19980415; FIRST REGISTRATION: GB - 10592/0078 19960228
0296560 2/1998 Austria ⤷  Try a Trial 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
0296560 SPC/GB97/023 United Kingdom ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.