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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.
US ANDA 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 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 215 |
| Clinical Trials: | 130 |
| Patent Applications: | 4,259 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ARICEPT |
| DailyMed Link: | ARICEPT at DailyMed |
Recent Clinical Trials for ARICEPT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mayo Clinic | Phase 1/Phase 2 |
| The University of Texas Health Science Center at San Antonio | Phase 1/Phase 2 |
| Dong-A ST Co., Ltd. | Phase 1 |
Pharmacology for ARICEPT
| Drug Class | Cholinesterase Inhibitor |
| Mechanism of Action | Cholinesterase Inhibitors |
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 |
International Patents for ARICEPT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 1038839 | Start Trial |
| Mexico | 2007007835 | Start Trial |
| Greece | 3036553 | Start Trial |
| Canada | 1340192 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
