NAMZARIC Drug Patent Profile
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Which patents cover Namzaric, and when can generic versions of Namzaric launch?
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-seven 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 eighteen 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 three 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: | 67 |
US Patents: | 12 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 2 |
Clinical Trials: | 2 |
Patent Applications: | 34 |
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 |
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 |
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
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compositions for the treatment of CNS-related conditions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods for the treatment of CNS-related conditions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbvie | NAMZARIC | donepezil hydrochloride; memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 206439-002 | Dec 23, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Abbvie | NAMZARIC | donepezil hydrochloride; memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 206439-002 | Dec 23, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Abbvie | NAMZARIC | donepezil hydrochloride; memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 206439-002 | Dec 23, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 |
---|---|---|---|---|---|---|---|
Abbvie | NAMZARIC | donepezil hydrochloride; memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 206439-001 | Dec 23, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | NAMZARIC | donepezil hydrochloride; memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 206439-002 | Dec 23, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
>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:
Austria
Patent: 81096
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Denmark | 1874282 | ⤷ Try a Trial | |
European Patent Office | 0392059 | USE OF ADAMANTANE DERIVATIVES IN THE PREVENTION AND TREATMENT OF CEREBRAL ISCHEMIA | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2005079773 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NAMZARIC
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0296560 | SPC/GB97/023 | United Kingdom | ⤷ Try a Trial | 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 | ⤷ Try a Trial | |
0392059 | 2002C/035 | Belgium | ⤷ Try a Trial | PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |