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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Colorcon
QuintilesIMS
Boehringer Ingelheim
Chubb
Healthtrust
US Army
Mallinckrodt
Fuji

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206439

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NDA 206439 describes NAMZARIC, which is a drug marketed by Forest Labs Llc and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug and three Paragraph IV challenges. Additional details are available on the NAMZARIC profile page.

The generic ingredient in NAMZARIC is donepezil hydrochloride; memantine hydrochloride. There are thirty-one drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride; memantine hydrochloride profile page.
Summary for 206439
Tradename:NAMZARIC
Applicant:Forest Labs Llc
Ingredient:donepezil hydrochloride; memantine hydrochloride
Patents:12
Formulation / Manufacturing:see details
Pharmacology for NDA: 206439
Suppliers and Packaging for NDA: 206439
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439 NDA Allergan, Inc. 0456-1207 N 0456-1207-30
NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439 NDA Allergan, Inc. 0456-1214 N 0456-1214-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG;14MG
Approval Date:Dec 23, 2014TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Sep 24, 2029Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Dec 5, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
Patent:➤ Sign UpPatent Expiration:May 22, 2026Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 206439

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-001 Dec 23, 2014 ➤ Sign Up ➤ Sign Up
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Department of Justice
Chubb
Daiichi Sankyo
US Army
Merck
Fish and Richardson
Accenture
Cipla

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