Donepezil hydrochloride; memantine hydrochloride - Generic Drug Details

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What are the generic drug sources for donepezil hydrochloride; memantine hydrochloride and what is the scope of freedom to operate?

Donepezil hydrochloride; memantine hydrochloride is the generic ingredient in two branded drugs marketed by Amneal Pharms, Ani Pharms, and Abbvie, and is included in three NDAs. There are twelve patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Donepezil hydrochloride; memantine hydrochloride has sixty-seven patent family members in nineteen countries.

Two suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for donepezil hydrochloride; memantine hydrochloride

International Patents:	67
US Patents:	12
Tradenames:	2
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	2
Clinical Trials:	26
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for donepezil hydrochloride; memantine hydrochloride
DailyMed Link:	donepezil hydrochloride; memantine hydrochloride at DailyMed

Recent Clinical Trials for donepezil hydrochloride; memantine hydrochloride

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

Sponsor	Phase
NeuroSense Therapeutics Ltd.	Phase 2
Peking Union Medical College Hospital	Phase 2
Tongji University	Phase 2

See all donepezil hydrochloride; memantine hydrochloride clinical trials

Generic filers with tentative approvals for DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	10MG;21MG	CAPSULE, EXTENDED RELEASE;ORAL
⤷ Sign Up	⤷ Sign Up	10MG;28MG	CAPSULE, EXTENDED RELEASE;ORAL
⤷ Sign Up	⤷ Sign Up	10MG;14MG	CAPSULE, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for donepezil hydrochloride; memantine hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for donepezil hydrochloride; memantine hydrochloride

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 DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

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 donepezil hydrochloride; memantine hydrochloride

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Glossary

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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	206439-001	Dec 23, 2014		RX	Yes	No	⤷ 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	206439-004	Jul 18, 2016	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ 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			Y	⤷ 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			Y	⤷ Sign Up
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-001	Dec 23, 2014		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ 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 donepezil hydrochloride; memantine hydrochloride

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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 donepezil hydrochloride; memantine hydrochloride

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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 donepezil hydrochloride; memantine hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Austria	E481096		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2006058059		⤷ Sign Up
Austria	E481096		⤷ Sign Up
European Patent Office	2243475	Combinaison de mémantine et donépézil pour le traitement de conditions relatives au SNC (Combination of memantine and donepezil for treatment of CNS disorders)	⤷ Sign Up
European Patent Office	1715843	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 GADPH-INHIBITOR FOR THE TREATMENT OF CENTRAL NERVOUS SYSTEM-RELATED CONDITIONS)	⤷ Sign Up
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)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for donepezil hydrochloride; memantine hydrochloride

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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