Namenda Xr is a drug owned by Abbvie Inc. It is protected by 16 US drug patents filed from 2013 to 2014. Out of these, 14 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 24, 2029. Details of Namenda Xr'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5061703 | Adamantane derivatives in the prevention and treatment of cerebral ischemia |
Apr, 2015
(9 years ago) |
Expired
|
|
US5061703 (Pediatric) | Adamantane derivatives in the prevention and treatment of cerebral ischemia |
Oct, 2015
(8 years ago) |
Expired
|
| US8362085 | Method for administering an NMDA receptor antagonist to a subject |
Nov, 2025
(1 year, 3 months from now) | Active |
| US8173708 | Method and composition for administering an NMDA receptor antagonist to a subject |
Nov, 2025
(1 year, 3 months from now) | Active |
| US8168209 | Method and composition for administering an NMDA receptor antagonist to a subject |
Nov, 2025
(1 year, 3 months from now) | Active |
| US8329752 | Composition for administering an NMDA receptor antagonist to a subject |
Nov, 2025
(1 year, 3 months from now) | Active |
| US8598233 | Method for administering an NMDA receptor antagonist to a subject |
Nov, 2025
(1 year, 3 months from now) | Active |
| US8283379 | Methods and compositions for the treatment of CNS-related conditions |
Nov, 2025
(1 year, 3 months from now) | Active |
|
US8168209 (Pediatric) | Method and composition for administering an NMDA receptor antagonist to a subject |
May, 2026
(1 year, 9 months from now) | Active |
|
US8283379 (Pediatric) | Methods and compositions for the treatment of CNS-related conditions |
May, 2026
(1 year, 9 months from now) | Active |
|
US8329752 (Pediatric) | Composition for administering an NMDA receptor antagonist to a subject |
May, 2026
(1 year, 9 months from now) | Active |
|
US8362085 (Pediatric) | Method for administering an NMDA receptor antagonist to a subject |
May, 2026
(1 year, 9 months from now) | Active |
|
US8173708 (Pediatric) | Method and composition for administering an NMDA receptor antagonist to a subject |
May, 2026
(1 year, 9 months from now) | Active |
|
US8598233 (Pediatric) | Method for administering an NMDA receptor antagonist to a subject |
May, 2026
(1 year, 9 months from now) | Active |
| US8039009 | Modified release formulations of memantine oral dosage forms |
Mar, 2029
(4 years from now) | Active |
|
US8039009 (Pediatric) | Modified release formulations of memantine oral dosage forms |
Sep, 2029
(5 years from now) | Active |
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 Namenda Xr's patents.
Latest Legal Activities on Namenda Xr's Patents
Given below is the list of recent legal activities going on the following patents of Namenda Xr.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Jun, 2024 | US8362085 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 May, 2024 | US8329752 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Mar, 2024 | US8283379 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Oct, 2023 | US8168209 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 12 Oct, 2023 | US8173708 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 09 Mar, 2023 | US8039009 (Litigated) |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 04 Mar, 2022 | US8173708 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 01 Mar, 2022 | US8168209 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 01 Mar, 2022 | US8283379 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Jun, 2021 | US8598233 |
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 Namenda Xr and ongoing litigations to help you estimate the early arrival of Namenda Xr generic.
Namenda Xr's Litigations
Namenda Xr has 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 or infringement of this patent, with Adamas Pharmaceuticals, Inc. as the respondent. Click below to track the latest information on how companies are challenging Namenda Xr's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8362085 | December, 2014 | Terminated-Denied | Adamas Pharmaceuticals, Inc. | Ranbaxy, Inc. |
FDA has granted some exclusivities to Namenda Xr. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Namenda Xr, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Namenda Xr.
Exclusivity Information
Namenda Xr holds 3 exclusivities. All of its exclusivities have expired in 2018. Details of Namenda Xr's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Jun 21, 2013 |
| M(M-138) | Jul 03, 2017 |
| Pediatric Exclusivity(PED) | Jan 03, 2018 |
Several oppositions have been filed on Namenda Xr'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 Namenda Xr's generic, the next section provides detailed information on ongoing and past EP oppositions related to Namenda Xr patents.
Namenda Xr's oppositions filed in EPO
Namenda Xr 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 Namenda Xr 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 Namenda Xr's family patents as well as insights into ongoing legal events on those patents.
Namenda Xr's family patents
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Generic Launch
Generic Release Date:
Namenda Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 24, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Namenda Xr Generics:
Memantine Hydrochloride is the generic name for the brand Namenda Xr. 35 different companies have already filed for the generic of Namenda Xr, with Aurobindo Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Namenda Xr's generic
How can I launch a generic of Namenda Xr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Namenda Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Namenda Xr'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 Namenda Xr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 7 mg, 14 mg, 21 mg, and 28 mg | 10 Jun, 2013 | 1 | 12 Oct, 2016 | Extinguished |
About Namenda Xr
Namenda Xr is a drug owned by Abbvie Inc. It is used for managing moderate to severe dementia in Alzheimer's disease. Namenda Xr uses Memantine Hydrochloride as an active ingredient. Namenda Xr was launched by Abbvie in 2010.
Market Authorisation Date:
Namenda Xr was approved by FDA for market use on 21 June, 2010.
Active Ingredient:
Namenda Xr uses Memantine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Memantine Hydrochloride ingredient
Treatment:
Namenda Xr is used for managing moderate to severe dementia in Alzheimer's disease.
Dosage:
Namenda Xr is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 21MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 7MG | CAPSULE, EXTENDED RELEASE | Discontinued | ORAL |
| 28MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 14MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |