Namzaric is a drug owned by Abbvie Inc. It is protected by 21 US drug patents filed from 2015 to 2016. Out of these, 19 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 05, 2029. Details of Namzaric's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8058291 | Methods and compositions for the treatment of CNS-related conditions |
Dec, 2029
(4 years from now) | Active |
|
US8039009 (Pediatric) | Modified release formulations of memantine oral dosage forms |
Sep, 2029
(4 years from now) | Active |
| US8039009 | Modified release formulations of memantine oral dosage forms |
Mar, 2029
(4 years from now) | Active |
|
US8283379 (Pediatric) | Methods and compositions for the treatment of CNS-related conditions |
May, 2026
(1 year, 5 months from now) | Active |
|
US8362085 (Pediatric) | Method for administering an NMDA receptor antagonist to a subject |
May, 2026
(1 year, 5 months from now) | Active |
|
US8329752 (Pediatric) | Composition for administering an NMDA receptor antagonist to a subject |
May, 2026
(1 year, 5 months from now) | Active |
|
US8598233 (Pediatric) | Method for administering an NMDA receptor antagonist to a subject |
May, 2026
(1 year, 5 months from now) | Active |
|
US8173708 (Pediatric) | Method and composition for administering an NMDA receptor antagonist to a subject |
May, 2026
(1 year, 5 months from now) | Active |
|
US8168209 (Pediatric) | Method and composition for administering an NMDA receptor antagonist to a subject |
May, 2026
(1 year, 5 months from now) | Active |
| US8329752 | Composition for administering an NMDA receptor antagonist to a subject |
Nov, 2025
(11 months from now) | Active |
| US8168209 | Method and composition for administering an NMDA receptor antagonist to a subject |
Nov, 2025
(11 months from now) | Active |
| US8293794 | Methods and compositions for the treatment of CNS-related conditions |
Nov, 2025
(11 months from now) | Active |
| US8173708 | Method and composition for administering an NMDA receptor antagonist to a subject |
Nov, 2025
(11 months from now) | Active |
| US8283379 | Methods and compositions for the treatment of CNS-related conditions |
Nov, 2025
(11 months from now) | Active |
| US8338486 | Methods for the treatment of CNS-related conditions |
Nov, 2025
(11 months from now) | Active |
| US8362085 | Method for administering an NMDA receptor antagonist to a subject |
Nov, 2025
(11 months from now) | Active |
| US8580858 | Compositions for the treatment of CNS-related conditions |
Nov, 2025
(11 months from now) | Active |
| US8598233 | Method for administering an NMDA receptor antagonist to a subject |
Nov, 2025
(11 months from now) | Active |
| US8338485 | Compositions for the treatment of CNS-related conditions |
Nov, 2025
(11 months from now) | Active |
|
US5061703 (Pediatric) | Adamantane derivatives in the prevention and treatment of cerebral ischemia |
Oct, 2015
(9 years ago) |
Expired
|
| US5061703 | Adamantane derivatives in the prevention and treatment of cerebral ischemia |
Apr, 2015
(9 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Namzaric's patents.
Latest Legal Activities on Namzaric's Patents
Given below is the list of recent legal activities going on the following patents of Namzaric.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Jun, 2024 | US8362085 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 May, 2024 | US8338486 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 May, 2024 | US8329752 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 May, 2024 | US8338485 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Mar, 2024 | US8283379 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Mar, 2024 | US8293794 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Oct, 2023 | US8173708 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Oct, 2023 | US8168209 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Apr, 2023 | US8058291 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 09 Mar, 2023 | US8039009 (Litigated) |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Namzaric and ongoing litigations to help you estimate the early arrival of Namzaric generic.
Namzaric's Litigations
Namzaric been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Dec 18, 2014, against patent number US8362085. The petitioner Ranbaxy, Inc., challenged the validity of this patent, with Adamas Pharmaceuticals, Inc. as the respondent. Click below to track the latest information on how companies are challenging Namzaric's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8362085 | December, 2014 |
Terminated-Denied
(15 May, 2015) | Adamas Pharmaceuticals, Inc. | Ranbaxy, Inc. |
Several oppositions have been filed on Namzaric's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Namzaric's generic, the next section provides detailed information on ongoing and past EP oppositions related to Namzaric patents.
Namzaric's Oppositions Filed in EPO
Namzaric has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 10, 2011, by Merz Pharma Gmbh & Co. Kgaa. This opposition was filed on patent number EP06749777A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP05852057A | Dec, 2013 | Elend, Almut Susanne | Revoked |
| EP06749777A | Jun, 2011 | Merz Pharma GmbH & Co. KGaA | Revoked |
US patents provide insights into the exclusivity only within the United States, but Namzaric is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Namzaric's family patents as well as insights into ongoing legal events on those patents.
Namzaric's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Namzaric's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 05, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Namzaric Generic API suppliers:
Donepezil Hydrochloride; Memantine Hydrochloride is the generic name for the brand Namzaric. 2 different companies have already filed for the generic of Namzaric, with Amneal Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Namzaric's generic
How can I launch a generic of Namzaric before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Namzaric's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Namzaric's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Namzaric -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 14 mg/10 mg and 28 mg/10 mg | 18 May, 2015 | 1 | 27 Jan, 2017 | 05 Dec, 2029 | Eligible |
| 21 mg/10 mg | 23 Sep, 2016 | 1 | 05 Dec, 2029 | ||
| 7 mg/10 mg | 26 Sep, 2016 | 1 | 05 Dec, 2029 | Extinguished |
About Namzaric
Namzaric is a drug owned by Abbvie Inc. It is used for managing moderate to severe dementia in Alzheimer's disease. Namzaric uses Donepezil Hydrochloride; Memantine Hydrochloride as an active ingredient. Namzaric was launched by Abbvie in 2016.
Approval Date:
Namzaric was approved by FDA for market use on 18 July, 2016.
Active Ingredient:
Namzaric uses Donepezil Hydrochloride; Memantine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Donepezil Hydrochloride; Memantine Hydrochloride ingredient
Treatment:
Namzaric is used for managing moderate to severe dementia in Alzheimer's disease.
Dosage:
Namzaric is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG;28MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 10MG;7MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 10MG;14MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 10MG;21MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |