Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020690

« Back to Dashboard
NDA 020690 describes ARICEPT, which is a drug marketed by Eisai Inc and is included in four NDAs. It is available from eight 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 drug master file entries for this compound. Fifty-six 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: 020690

Eisai Inc
donepezil hydrochloride
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020690

Mechanism of ActionCholinesterase Inhibitors

Suppliers and Packaging for NDA: 020690

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
donepezil hydrochloride
TABLET;ORAL 020690 NDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7623 0615-7623-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7623-39)
donepezil hydrochloride
TABLET;ORAL 020690 NDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7624 0615-7624-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7624-39)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 25, 1996TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 25, 1996TE:ABRLD:No

Expired Orange Book Patents for NDA: 020690

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc
donepezil hydrochloride
TABLET;ORAL020690-002Nov 25, 19964,895,841► subscribe
Eisai Inc
donepezil hydrochloride
TABLET;ORAL020690-001Nov 25, 19964,895,841► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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.