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Last Updated: October 7, 2024

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NAMZARIC Drug Patent Profile


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

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

This drug has sixty-seven patent family members in nineteen 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.

DrugPatentWatch® Generic Entry Outlook for Namzaric

There have been eighteen 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 three tentative approvals for the generic drug (donepezil hydrochloride; memantine hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for NAMZARIC
Drug Prices for NAMZARIC

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Recent Clinical Trials for NAMZARIC

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

SponsorPhase
Varian Medical SystemsPhase 3
AllerganPhase 3
Duke UniversityPhase 3

See all NAMZARIC clinical trials

Paragraph IV (Patent) Challenges for NAMZARIC
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NAMZARIC Capsules donepezil hydrochloride; memantine hydrochloride 7 mg/10 mg 206439 1 2016-09-26
NAMZARIC Capsules donepezil hydrochloride; memantine hydrochloride 21 mg/10 mg 206439 1 2016-09-23
NAMZARIC Capsules donepezil hydrochloride; memantine hydrochloride 14 mg/10 mg and 28 mg/10 mg 206439 1 2015-05-18

US Patents and Regulatory Information for NAMZARIC

NAMZARIC is protected by five US patents.

Patents protecting NAMZARIC

Methods and compositions for the treatment of CNS-related conditions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE

Methods and compositions for the treatment of CNS-related conditions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compositions for the treatment of CNS-related conditions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods for the treatment of CNS-related conditions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE

Compositions for the treatment of CNS-related conditions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Abbvie NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Abbvie NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-003 Jul 18, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Abbvie NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-001 Dec 23, 2014 ⤷  Sign Up ⤷  Sign Up
Abbvie 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

EU/EMA Drug Approvals for NAMZARIC

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
H. Lundbeck A/S Acrescent memantine hydrochloride, donepezil hydrochloride EMEA/H/C/002424
Treatment of Alzheimers disease
Refused no no no 2013-02-20
Merz Pharmaceuticals GmbH Balaxur memantine hydrochloride, donepezil hydrochloride EMEA/H/C/002708
Refused no no no 2013-02-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for NAMZARIC

When does loss-of-exclusivity occur for NAMZARIC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Austria

Patent: 81096
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering NAMZARIC around the world.

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 200700049 ПРЕПАРАТИВНЫЕ ФОРМЫ ОРАЛЬНЫХ ЛЕКАРСТВЕННЫХ ФОРМ МЕМАНТИНА С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ ⤷  Sign Up
European Patent Office 1874282 PROCEDES ET COMPOSITIONS POUR LE TRAITEMENT DES PATHOLOGIES ASSOCIEES AU SYSTEME NERVEUX CENTRAL (METHODS AND COMPOSITIONS FOR TREATMENT OF CNS DISORDERS) ⤷  Sign Up
Japan 2008535867 ⤷  Sign Up
Switzerland 679208 ⤷  Sign Up
South Korea 101406456 ⤷  Sign Up
European Patent Office 0392059 USE OF ADAMANTANE DERIVATIVES IN THE PREVENTION AND TREATMENT OF CEREBRAL ISCHEMIA ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NAMZARIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0392059 0290025-6 Sweden ⤷  Sign Up PRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515
0392059 90988 Luxembourg ⤷  Sign Up
0392059 2002C/035 Belgium ⤷  Sign Up PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
0392059 SPC/GB02/046 United Kingdom ⤷  Sign Up 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
0296560 SPC/GB97/023 United Kingdom ⤷  Sign Up 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
0296560 2/1998 Austria ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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