ARICEPT Drug Patent Profile

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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aricept

A generic version of ARICEPT was approved as donepezil hydrochloride by ACI on May 31^st, 2011.

Summary for ARICEPT

International Patents:	36
US Patents:	1
Applicants:	1
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	285
Clinical Trials:	149
Patent Applications:	4,467
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ARICEPT
What excipients (inactive ingredients) are in ARICEPT?	ARICEPT excipients list
DailyMed Link:	ARICEPT at DailyMed

See drug prices for ARICEPT

See drug sales revenues for ARICEPT

Recent Clinical Trials for ARICEPT

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

Sponsor	Phase
Vanderbilt University Medical Center	Early Phase 1
Inventage Lab., Inc.	Phase 1/Phase 2
G2GBio, Inc.	Phase 1

See all ARICEPT clinical trials

Pharmacology for ARICEPT

Drug Class	Cholinesterase Inhibitor
Mechanism of Action	Cholinesterase Inhibitors

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

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
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	022568-001	Jul 23, 2010	AB	RX	Yes	Yes			Y
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-002	Nov 25, 1996	AB	RX	Yes	No

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
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-002	Nov 25, 1996

International Patents for ARICEPT

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

Country	Patent Number	Title	Estimated Expiration
Japan	2005015486	POLYMORPHIC CRYSTAL OF DONEPEZIL HYDROCHLORIDE AND MANUFACTURE METHOD THEREOF
Finland	103969
Russian Federation	2390354	ПРЕПАРАТ МАТРИЧНОГО ТИПА С ЗАМЕДЛЕННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЙ ОСНОВНОЕ ЛЕКАРСТВЕННОЕ СРЕДСТВО ИЛИ ЕГО СОЛЬ, И СПОСОБ ЕГО ПОЛУЧЕНИЯ (SLOW-RELEASE MATRIX PREPARATION CONTAINING BASE AGENT OR ITS SALT AND METHOD FOR MAKING THEREOF)

Supplementary Protection Certificates for ARICEPT

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