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Last Updated: August 9, 2020

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ARICEPT ODT Drug Profile

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When do Aricept Odt patents expire, and what generic alternatives are available?

Aricept Odt is a drug marketed by Eisai Inc and is included in one NDA.

The generic ingredient in ARICEPT ODT 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.

Summary for ARICEPT ODT
Drug patent expirations by year for ARICEPT ODT
Recent Clinical Trials for ARICEPT ODT

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

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

See all ARICEPT ODT clinical trials

Pharmacology for ARICEPT ODT
Paragraph IV (Patent) Challenges for ARICEPT ODT
Tradename Dosage Ingredient NDA Submissiondate
ARICEPT ODT TABLET, ORALLY DISINTEGRATING;ORAL donepezil hydrochloride 021720 2010-06-30

US Patents and Regulatory Information for ARICEPT ODT

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 ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-001 Oct 18, 2004 DISCN Yes No   Start Trial   Start Trial   Start Trial
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-002 Oct 18, 2004 DISCN Yes No   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 ODT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-001 Oct 18, 2004   Start Trial   Start Trial
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-002 Oct 18, 2004   Start Trial   Start Trial
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-002 Oct 18, 2004   Start Trial   Start Trial
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-001 Oct 18, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ARICEPT ODT

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 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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