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Details for New Drug Application (NDA): 020690
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NDA 020690 describes ARICEPT, which is a drug marketed by Eisai Inc and is included in four NDAs. It is available from two suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the ARICEPT profile page.
The generic ingredient in ARICEPT is donepezil hydrochloride. There are thirty-two drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.
The generic ingredient in ARICEPT is donepezil hydrochloride. There are thirty-two drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.
Summary for 020690
| Tradename: | ARICEPT |
| Applicant: | Eisai Inc |
| Ingredient: | donepezil hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020690
| Mechanism of Action | Cholinesterase Inhibitors |
Suppliers and Packaging for NDA: 020690
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690 | NDA | PD-Rx Pharmaceuticals, Inc. | 55289-151 | 55289-151-21 | 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-151-21) |
| ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690 | NDA | PD-Rx Pharmaceuticals, Inc. | 55289-151 | 55289-151-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-151-30) |
Paragraph IV (Patent) Challenges for 020690
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ARICEPT | TABLET;ORAL | donepezil hydrochloride | 020690 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Nov 25, 1996 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Nov 25, 1996 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020690
| 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 | 020690-001 | Nov 25, 1996 | Start Trial | Start Trial |
| Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690-001 | Nov 25, 1996 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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