Flexible Subscriptions to Match your Budget and Timeline See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Merck
McKesson
Moodys
McKinsey
Dow
Harvard Business School

Last Updated: June 29, 2022

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 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.

DrugPatentWatch® 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 >

  Try it Free

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions for the treatment of CNS-related conditions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for the treatment of CNS-related conditions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Allergan NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 See Plans and Pricing See Plans and Pricing
>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:

Australia

Patent: 05209310
Estimated Expiration: See Plans and Pricing

Patent: 05215767
Estimated Expiration: See Plans and Pricing

Patent: 05215775
Estimated Expiration: See Plans and Pricing

Patent: 05309601
Estimated Expiration: See Plans and Pricing

Patent: 06244297
Estimated Expiration: See Plans and Pricing

Austria

Patent: 1096
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0518483
Estimated Expiration: See Plans and Pricing

Patent: 0607017
Estimated Expiration: See Plans and Pricing

Canada

Patent: 54959
Estimated Expiration: See Plans and Pricing

Patent: 56214
Estimated Expiration: See Plans and Pricing

Patent: 56216
Estimated Expiration: See Plans and Pricing

Patent: 88295
Estimated Expiration: See Plans and Pricing

Patent: 04052
Estimated Expiration: See Plans and Pricing

China

Patent: 29830
Estimated Expiration: See Plans and Pricing

Patent: 1060830
Estimated Expiration: See Plans and Pricing

Patent: 1247795
Estimated Expiration: See Plans and Pricing

Patent: 1686945
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 74282
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 15843
Estimated Expiration: See Plans and Pricing

Patent: 27538
Estimated Expiration: See Plans and Pricing

Patent: 34920
Estimated Expiration: See Plans and Pricing

Patent: 89028
Estimated Expiration: See Plans and Pricing

Patent: 27385
Estimated Expiration: See Plans and Pricing

Patent: 74282
Estimated Expiration: See Plans and Pricing

Patent: 43475
Estimated Expiration: See Plans and Pricing

Patent: 43057
Estimated Expiration: See Plans and Pricing

Germany

Patent: 852057
Estimated Expiration: See Plans and Pricing

Patent: 2006016934
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 03517
Estimated Expiration: See Plans and Pricing

Patent: 06711
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3384
Estimated Expiration: See Plans and Pricing

Patent: 6504
Estimated Expiration: See Plans and Pricing

Japan

Patent: 66087
Estimated Expiration: See Plans and Pricing

Patent: 07522248
Estimated Expiration: See Plans and Pricing

Patent: 07522249
Estimated Expiration: See Plans and Pricing

Patent: 08520736
Estimated Expiration: See Plans and Pricing

Patent: 08535867
Estimated Expiration: See Plans and Pricing

Patent: 09173669
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 07006120
Estimated Expiration: See Plans and Pricing

Patent: 07012374
Estimated Expiration: See Plans and Pricing

Poland

Patent: 74282
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 04750
Estimated Expiration: See Plans and Pricing

Patent: 07122410
Estimated Expiration: See Plans and Pricing

Patent: 07140348
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 7415
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0704233
Estimated Expiration: See Plans and Pricing

Patent: 0709535
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1301429
Estimated Expiration: See Plans and Pricing

Patent: 1406456
Estimated Expiration: See Plans and Pricing

Patent: 060124731
Estimated Expiration: See Plans and Pricing

Patent: 070112763
Estimated Expiration: See Plans and Pricing

Patent: 070116996
Estimated Expiration: See Plans and Pricing

Spain

Patent: 51709
Estimated Expiration: See Plans and Pricing

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
South Africa 200709535 Methods and compositions for the treatment of CNS-related conditions See Plans and Pricing
Japan 2821233 See Plans and Pricing
Russian Federation 2404750 КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ОСНОВУ ИЛИ ПОКРЫТИЕ ДЛЯ ЗАМЕДЛЕННОГО ВЫСВОБОЖДЕНИЯ И АНТАГОНИСТ NMDA РЕЦЕПТОРА, СПОСОБ ВВЕДЕНИЯ ТАКОГО NMDA АНТАГОНИСТА СУБЪЕКТУ (COMPOSITION CONTAINING BASE OR COAT FOR MODERATED RELEASE AND ANTAGONIST OF NMDA RECEPTOR, METHOD FOR INTRODUCTION OF SUCH NMDA ANTAGONIST TO INDIVIDUAL) See Plans and Pricing
Eurasian Patent Organization 200700049 ПРЕПАРАТИВНЫЕ ФОРМЫ ОРАЛЬНЫХ ЛЕКАРСТВЕННЫХ ФОРМ МЕМАНТИНА С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ See Plans and Pricing
Brazil PI0512177 formulação de liberação modificada de memantina See Plans and Pricing
South Africa 200704233 Composition comprising a sustained release coating or matrix and an NMDA receptor antagonist, method for administration such NMDA antagonist to a subject See Plans and Pricing
>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 See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517
0296560 SPC/GB97/023 United Kingdom See Plans and Pricing 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 90988 Luxembourg See Plans and Pricing
0392059 0290025-6 Sweden See Plans and Pricing PRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515
0296560 2/1998 Austria See Plans and Pricing 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

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.