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-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. Thirty-eight 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 AUROBINDO on May 31st, 2011.
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Questions you can ask:
- What is the 5 year forecast for ARICEPT?
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- What is Average Wholesale Price for ARICEPT?
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: | 150 |
| Patent Applications: | 4,468 |
| Drug Prices: | Drug price information 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 |
|---|---|
| Vanderbilt University Medical Center | Early Phase 1 |
| Inventage Lab., Inc. | Phase 1/Phase 2 |
| G2GBio, Inc. | Phase 1 |
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
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 022568-001 | Jul 23, 2010 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690-002 | Nov 25, 1996 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690-001 | Nov 25, 1996 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Eisai Inc | ARICEPT ODT | donepezil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021720-002 | Oct 18, 2004 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Eisai Inc | ARICEPT ODT | donepezil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021720-001 | Oct 18, 2004 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | 020690-002 | Nov 25, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690-002 | Nov 25, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690-002 | Nov 25, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690-001 | Nov 25, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690-001 | Nov 25, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690-001 | Nov 25, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Singapore | 50439 | Cyclic amine compound its use and pharmaceutical compositions comprising it | ⤷ Sign Up |
| Canada | 2592605 | METHODE DE STABILISATION D'UN MEDICAMENT CONTRE LA DEMENCE (METHOD FOR STABILIZING ANTI-DEMENTIA DRUG) | ⤷ Sign Up |
| South Korea | 100866720 | ⤷ Sign Up | |
| Australia | 1153097 | ⤷ Sign Up | |
| Norway | 882696 | ⤷ Sign Up | |
| Denmark | 1019374 | ⤷ Sign Up | |
| >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 | ⤷ Sign Up | PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21 303 19980415; FIRST REGISTRATION: GB - 10592/0078 19960228 |
| 0296560 | 2/1998 | Austria | ⤷ Sign Up | 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 | ⤷ Sign Up | 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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