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Generated: April 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022568

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NDA 022568 describes ARICEPT, which is a drug marketed by Eisai Inc and is included in four NDAs. It is available from nine 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-one drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the donepezil hydrochloride profile page.

Summary for NDA: 022568

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022568

Mechanism of ActionCholinesterase Inhibitors

Suppliers and Packaging for NDA: 022568

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARICEPT
donepezil hydrochloride
TABLET;ORAL 022568 NDA Eisai Inc. 62856-247 62856-247-30 30 TABLET, FILM COATED in 1 BOTTLE (62856-247-30)
ARICEPT
donepezil hydrochloride
TABLET;ORAL 022568 NDA Avera McKennan Hospital 69189-0247 69189-0247-1 1 TABLET, FILM COATED in 1 DOSE PACK (69189-0247-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength23MG
Approval Date:Jul 23, 2010TE:ABRLD:Yes
Patent:8,481,565Patent Expiration:Oct 4, 2026Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022568

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL022568-001Jul 23, 20104,895,841► Subscribe
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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 verifification 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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