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 |
Tongji University | Phase 2 |
Peking Union Medical College Hospital | 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
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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