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Last Updated: May 24, 2022

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-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. Thirty-nine 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

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

SponsorPhase
Assistance Publique - Hôpitaux de ParisPhase 3
France AlzheimerPhase 3
Association France Alzheimer Et Maladies ApparentéesPhase 3

See all ARICEPT clinical trials

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 022568-001 Jul 23, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-001 Nov 25, 1996 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-002 Oct 18, 2004 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996 See Plans and Pricing See Plans and Pricing
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996 See Plans and Pricing See Plans and Pricing
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-001 Nov 25, 1996 See Plans and Pricing See Plans and Pricing
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996 See Plans and Pricing See Plans and Pricing
>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
Czech Republic 296619 Modifikace donepezilhydrochloridu, zpusob její výroby a pouzití (Modification of donepezil hydrochloride, process for its preparation and use) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006070781 See Plans and Pricing
Germany 69739622 See Plans and Pricing
Brazil PI0519407 preparaÇço de liberaÇço sustentada do tipo matriz contendo droga bÁsica ou seu sal e mÉtodo para a fabricaÇço da mesma See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006070930 See Plans and Pricing
>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 See Plans and Pricing PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21 303 19980415; FIRST REGISTRATION: GB - 10592/0078 19960228
0296560 2/1998 Austria See Plans and Pricing 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 See Plans and Pricing 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
McKesson
Express Scripts
AstraZeneca
Moodys

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