You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

~ Buy the NAMZARIC (donepezil hydrochloride; memantine hydrochloride) Drug Profile, 2024 PDF Report in the Report Store ~

NAMZARIC Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

< Available with Subscription >

  Try a 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
AllerganPhase 3
Duke UniversityPhase 3
Varian Medical SystemsPhase 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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compositions for the treatment of CNS-related conditions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods for the treatment of CNS-related conditions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Abbvie NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Abbvie NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Abbvie NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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
Abbvie NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-001 Dec 23, 2014 ⤷  Try a Trial ⤷  Try a Trial
Abbvie NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 ⤷  Try a Trial ⤷  Try a Trial
>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: ⤷  Try a Trial

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
China 1929830 Combination of an NMDA receptor antagonist and an anti-epileptic drug for the treatment of epilepsy and other CNA disorders, and method therefor ⤷  Try a Trial
Russian Federation 2007122410 КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ОСНОВУ ИЛИ ПОКРЫТИЕ ДЛЯ ЗАМЕДЛЕННОГО ВЫСВОБОЖДЕНИЯ И АНТАГОНИСТ NMDA-РЕЦЕПТОРА, СПОСОБ ВВЕДЕНИЯ ТАКОГО NMDA-АНТАГОНИСТА СУБЪЕКТУ ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2005072705 ⤷  Try a Trial
Australia 2005209310 Combination of a NMDA receptor antagonist and a MAO-inhibitor or a GADPH-inhibitor for the treatment of central nervous system-related conditions ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NAMZARIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0392059 SPC/GB02/046 United Kingdom ⤷  Try a 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 90988 Luxembourg ⤷  Try a Trial
0296560 SPC/GB97/023 United Kingdom ⤷  Try a 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 0290025-6 Sweden ⤷  Try a 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

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.