NAMZARIC Drug Patent Profile
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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-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
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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 |
| 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 |
|---|---|
| Allergan | Phase 3 |
| Duke University | Phase 3 |
| Varian Medical Systems | Phase 3 |
Pharmacology for NAMZARIC
| Drug Class | Cholinesterase Inhibitor N-methyl-D-aspartate Receptor Antagonist |
| Mechanism of Action | Cholinesterase Inhibitors NMDA Receptor Antagonists |
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compositions for the treatment of CNS-related conditions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods for the treatment of CNS-related conditions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ 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 | 206439-002 | Dec 23, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abbvie | NAMZARIC | donepezil hydrochloride; memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 206439-003 | Jul 18, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 | ⤷ 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 NAMZARIC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | NAMZARIC | donepezil hydrochloride; memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 206439-002 | Dec 23, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | NAMZARIC | donepezil hydrochloride; memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 206439-001 | Dec 23, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| >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: ⤷ Sign Up
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 |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2005079773 | ⤷ Sign Up | |
| Japan | 2008520736 | ⤷ Sign Up | |
| Canada | 2604052 | PROCEDES ET COMPOSITIONS POUR LE TRAITEMENT DES PATHOLOGIES ASSOCIEES AU SYSTEME NERVEUX CENTRAL (METHODS AND COMPOSITIONS FOR TREATMENT OF CNS DISORDERS) | ⤷ Sign Up |
| Hungary | T58200 | ⤷ Sign Up | |
| China | 101247795 | Methods and compositions for treatment of CNS disorders | ⤷ Sign Up |
| Germany | 10299048 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NAMZARIC
| 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 |
| 0392059 | SPC/GB02/046 | United Kingdom | ⤷ Sign Up | 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 | 2002C/035 | Belgium | ⤷ Sign Up | PRODUCT NAME: MEMANTINE; REGISTRATION NO/DATE: EU/1/02/219/001 20020517 |
| 0392059 | 90988 | Luxembourg | ⤷ Sign Up | |
| 0392059 | 0290025-6 | Sweden | ⤷ Sign Up | PRODUCT NAME: MEMANTIN, 1-AMINO-3,5-DIMETYLADAMANTAN; REGISTRATION NO/DATE: EU/1/02/219/001 20020515 |
| 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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