ARICEPT ODT Drug Patent 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. 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 Odt
A generic version of ARICEPT ODT was approved as donepezil hydrochloride by AUROBINDO on May 31st, 2011.
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Questions you can ask:
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Summary for ARICEPT ODT
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 285 |
Clinical Trials: | 150 |
Patent Applications: | 4,015 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ARICEPT ODT |
DailyMed Link: | ARICEPT ODT at DailyMed |
Recent Clinical Trials for ARICEPT ODT
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 |
Paragraph IV (Patent) Challenges for ARICEPT ODT
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ARICEPT ODT | Orally Disintegrating Tablets | donepezil hydrochloride | 5 mg and 10 mg | 021720 | 1 | 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 | ⤷ 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 | ||||
>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 | 021720-002 | Oct 18, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Eisai Inc | ARICEPT ODT | donepezil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021720-001 | Oct 18, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Eisai Inc | ARICEPT ODT | donepezil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021720-001 | Oct 18, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Eisai Inc | ARICEPT ODT | donepezil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021720-002 | Oct 18, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Eisai Inc | ARICEPT ODT | donepezil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021720-001 | Oct 18, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Eisai Inc | ARICEPT ODT | donepezil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021720-002 | Oct 18, 2004 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ARICEPT ODT
See the table below for patents covering ARICEPT ODT around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 1071417 | ⤷ Sign Up | |
Cyprus | 1940 | 1,4-substituted piperidines as acetylcholinesterase inhibitors and their use for the treatment of Alzheimer's disease | ⤷ Sign Up |
Denmark | 175717 | ⤷ Sign Up | |
Germany | 3856251 | ⤷ Sign Up | |
Spain | 2164720 | ⤷ Sign Up | |
Hungary | 211165 | ⤷ Sign Up | |
Japan | 3770518 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ARICEPT ODT
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 |