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Last Updated: January 18, 2020

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Details for New Drug Application (NDA): 206439

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NDA 206439 describes NAMZARIC, which is a drug marketed by Allergan 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-two 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:Allergan
Ingredient:donepezil hydrochloride; memantine hydrochloride
Patents:12
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 0456-1207-30 30 CAPSULE in 1 BOTTLE (0456-1207-30)
NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439 NDA Allergan, Inc. 0456-1214 0456-1214-11 10 CAPSULE in 1 BLISTER PACK (0456-1214-11)
Paragraph IV (Patent) Challenges for 206439
Tradename Dosage Ingredient NDA Submissiondate
NAMZARIC CAPSULE, EXTENDED RELEASE;ORAL donepezil hydrochloride; memantine hydrochloride 206439 2016-09-26
NAMZARIC CAPSULE, EXTENDED RELEASE;ORAL donepezil hydrochloride; memantine hydrochloride 206439 2016-09-23
NAMZARIC CAPSULE, EXTENDED RELEASE;ORAL donepezil hydrochloride; memantine hydrochloride 206439 2015-05-18

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG;14MG
Approval Date:Dec 23, 2014TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Sep 24, 2029Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent 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:  Start TrialPatent 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
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-001 Dec 23, 2014   Start Trial   Start Trial
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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