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Last Updated: August 11, 2020

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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-seven 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-four suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.

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

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SponsorPhase
Mayo ClinicPhase 1/Phase 2
The University of Texas Health Science Center at San AntonioPhase 1/Phase 2
Dong-A ST Co., Ltd.Phase 1

See all ARICEPT clinical trials

Pharmacology for ARICEPT
Paragraph IV (Patent) Challenges for ARICEPT
Tradename Dosage Ingredient NDA Submissiondate
ARICEPT TABLET;ORAL donepezil hydrochloride 022568 2013-07-09
ARICEPT TABLET;ORAL donepezil hydrochloride 020690

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

Supplementary Protection Certificates for ARICEPT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0296560 98C0015 Belgium   Start Trial PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21 303 19980415; FIRST REGISTRATION: GB - 10592/0078 19960228
0296560 2/1998 Austria   Start 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   Start 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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Serving leading biopharmaceutical companies globally:

Colorcon
Baxter
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Express Scripts
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Moodys

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