You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Merck
McKesson
Moodys
McKinsey
Dow
Harvard Business School

Last Updated: August 14, 2020

DrugPatentWatch Database Preview

NAMZARIC Drug Profile

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

Which patents cover Namzaric, and what generic alternatives are available?

Namzaric is a drug marketed by Allergan and is included in one NDA. There are twelve patents protecting this drug and three Paragraph IV challenges.

This drug has seventy patent family members in twenty countries.

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.

US ANDA Litigation and Generic Entry Outlook for Namzaric

There have been twenty patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (donepezil hydrochloride; memantine hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

< Available with Subscription >

  Start Trial

Drug patent expirations by year for NAMZARIC
Drug Prices for NAMZARIC

See drug prices for NAMZARIC

Recent Clinical Trials for NAMZARIC

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Suven Life Sciences LimitedPhase 2

See all NAMZARIC clinical trials

Paragraph IV (Patent) Challenges for NAMZARIC
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

US Patents and Regulatory Information for NAMZARIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for NAMZARIC

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

Supplementary Protection Certificates for NAMZARIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0296560 SPC/GB97/023 United Kingdom   Start Trial PRODUCT NAME: DONEPEZIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE HYDROCHLORIDE; REGISTERED: UK PL 10555/0006 19970214; UK PL 10555/0007 19970214
0392059 SPC/GB02/046 United Kingdom   Start Trial PRODUCT NAME: MEMANTINE AND ITS PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/02/219/001 20020515; UK EU/1/02/219/002 20020515; UK EU/1/02/219/003 20020515; UK EU/1/02/219/004 20020515; UK EU/1/02/219/005 20020515; UK EU/1/02/219/006 20020515
0392059 2002C/035 Belgium   Start Trial PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
0296560 2/1998 Austria   Start Trial PRODUCT NAME: DONEPEZIL UND SEINE PHARMAKOLOGISCH ANNEHMBAREN SALZE, INSBESONDERE DONEPEZIL HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-22056, 1-22057 19970728; FIRST REGISTRATION: GB PL105550006, PL105550007 19970214
0392059 90988 Luxembourg   Start Trial
0392059 0290025-6 Sweden   Start Trial PRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
McKesson
McKinsey
Mallinckrodt
Johnson and Johnson
Moodys

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 verification 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.