NAMZARIC Drug Patent Profile

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-eight 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 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

Summary for NAMZARIC

International Patents:	68
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	2
Patent Applications:	45
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for NAMZARIC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NAMZARIC
What excipients (inactive ingredients) are in NAMZARIC?	NAMZARIC excipients list
DailyMed Link:	NAMZARIC at DailyMed

See drug prices for NAMZARIC

Recent Clinical Trials for NAMZARIC

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

Sponsor	Phase
Varian Medical Systems	Phase 3
Allergan	Phase 3
Duke University	Phase 3

See all NAMZARIC clinical trials

Pharmacology for NAMZARIC

Drug Class	Cholinesterase Inhibitor N-methyl-D-aspartate Receptor Antagonist
Mechanism of Action	Cholinesterase Inhibitors NMDA Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for NAMZARIC

N06DA	Anticholinesterases
N06D	ANTI-DEMENTIA DRUGS
N06	PSYCHOANALEPTICS
N	Nervous system

N06DX	Other anti-dementia drugs
N06D	ANTI-DEMENTIA DRUGS
N06	PSYCHOANALEPTICS
N	Nervous system

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

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			Y
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-004	Jul 18, 2016		RX	Yes	No					Y
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-002	Dec 23, 2014		RX	Yes	Yes					Y
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-004	Jul 18, 2016		RX	Yes	No			Y
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-004	Jul 18, 2016		RX	Yes	No					Y
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-004	Jul 18, 2016		RX	Yes	No			Y
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-003	Jul 18, 2016		RX	Yes	No

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
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-002	Dec 23, 2014

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

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

Austria

Brazil

Canada

China

Denmark

European Patent Office

Germany

Hong Kong

Japan

Mexico

Poland

Russian Federation

Singapore

South Africa

South Korea

Spain

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
Russian Federation	2007122410	КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ОСНОВУ ИЛИ ПОКРЫТИЕ ДЛЯ ЗАМЕДЛЕННОГО ВЫСВОБОЖДЕНИЯ И АНТАГОНИСТ NMDA-РЕЦЕПТОРА, СПОСОБ ВВЕДЕНИЯ ТАКОГО NMDA-АНТАГОНИСТА СУБЪЕКТУ
Hong Kong	1103517	PHARMACEUTICAL COMPOSITION COMPRISING MEMANTINE IN AN EXTENDED DOSAGE RELEASE FORM FOR USE IN THE TREATMENT OF DEMENTIAS
Canada	2556214	METHODES ET COMPOSITIONS DESTINEES AU TRAITEMENT DE L'EPILEPSIE, DES TROUBLES EPILEPTIQUES ET D'AUTRES TROUBLES DU SYSTEME NERVEUX CENTRAL (COMBINATION OF AN NMDA RECEPTOR ANTAGONIST AND AN ANTI-EPILEPTIC DRUG FOR THE TREATMENT OF EPILEPSY AND OTHER CNS DISORDERS)
Canada	2556216	METHODES ET COMPOSITIONS DE TRAITEMENT DE TROUBLES PSYCHIATRIQUES (COMBINATION OF A NMDA RECEPTOR ANTAGONIST AND AN ANTI-DEPRESSIVE DRUG MAO-INHIBITOR OR A GADPH-INHIBITOR FOR THE TREATMENT OF PSYCHIATRIC CONDITIONS)
Canada	2554959	COMBINAISON D'ANTAGONISTE DE RECEPTEUR NMDA ET D'INHIBITEUR MAO OU GADPF POUR LE TRAITEMENT D'AFFECTIONS LIEES AU SYSTEME NERVEUX CENTRAL (COMBINATION OF A NMDA RECEPTOR ANTAGONIST AND A MAO-INHIBITOR OR A GADPF-INHIBITOR FOR THE TREATMENT OF CENTRAL NERVOUS SYSTEM-RELATED CONDITIONS)
Canada	2588295	PROCEDE ET COMPOSITION POUR ADMINISTRER UN ANTAGONISTE DU RECEPTEUR DE NMDA A UN SUJET (COMPOSITION COMPRISING A SUSTAINED RELEASE COATING OR MATRIXAND AN NMDA RECEPTOR ANTAGONIST, METHOD FOR ADMINISTRATION SUCH NMDA ANTAGONIST TO A SUBJECT)
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)

Supplementary Protection Certificates for NAMZARIC

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