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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Aricept
A generic version of ARICEPT was approved as donepezil hydrochloride by SANDOZ on May 10th, 2011.
Summary for ARICEPT
International Patents: | 37 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 4 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 247 |
Clinical Trials: | 145 |
Patent Applications: | 4,397 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ARICEPT |
Drug Sales Revenues: | Drug sales revenues for ARICEPT |
What excipients (inactive ingredients) are in ARICEPT? | ARICEPT excipients list |
DailyMed Link: | ARICEPT at DailyMed |



Recent Clinical Trials for ARICEPT
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Assistance Publique - Hôpitaux de Paris | Phase 3 |
France Alzheimer | Phase 3 |
Association France Alzheimer Et Maladies Apparentées | Phase 3 |
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 |