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Last Updated: November 2, 2024

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.

Recent Clinical Trials for donepezil hydrochloride; memantine hydrochloride

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

SponsorPhase
NeuroSense Therapeutics Ltd.Phase 2
Tongji UniversityPhase 2
Peking Union Medical College HospitalPhase 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 Up10MG;21MGCAPSULE, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up10MG;28MGCAPSULE, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up10MG;14MGCAPSULE, 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
Anatomical Therapeutic Chemical (ATC) Classes for donepezil hydrochloride; memantine hydrochloride
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

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 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
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 206439-004 Jul 18, 2016 AB 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

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

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

Country Patent Number Title Estimated Expiration
Australia 2005215767 Combination of an NMDA receptor antagonist and an anti-epileptic drug for the treatment of epilepsy and other CNS disorders ⤷  Sign Up
China 101686945 Composition comprising a sustained release coating or matrix and an nmda receptor antagonist, method for administration such nmda antagonist to a subject ⤷  Sign Up
Denmark 1874282 ⤷  Sign Up
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) ⤷  Sign Up
European Patent Office 1734920 COMBINAISON D'UN ANTAGONISTE DU RECEPTEUR NMDA ET D'UN INHIBITEUR MAO OU GADPF POUR LE TRAITEMENT DES TROUBLES PSYCHIATRIQUES (COMBINATION OF A NMDA RECEPTOR ANTAGONIST AND AN MAO-INHIBITOR OR A GADPH-INHIBITOR FOR THE TREATMENT OF PSYCHIATRIC CONDITIONS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for donepezil hydrochloride; memantine hydrochloride

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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