Nuedexta is a drug owned by Avanir Pharmaceuticals Inc. It is protected by 3 US drug patents filed in 2013. Out of these, 1 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 13, 2026. Details of Nuedexta'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). | |||
| US7659282 | Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders |
Aug, 2026
(1 year, 7 months from now) | Active |
| US8227484 | Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders |
Jul, 2023
(1 year, 5 months ago) |
Expired
|
| USRE38115 | Dextromethorphan and an oxidase inhibitor for treating intractable conditions |
Jan, 2016
(8 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 Nuedexta's patents.
Latest Legal Activities on Nuedexta's Patents
Given below is the list of recent legal activities going on the following patents of Nuedexta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 11 Mar, 2024 | US8227484 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 28 Jul, 2021 | US7659282 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Jan, 2020 | US8227484 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 16 Oct, 2014 | US8227484 |
| Recordation of Patent Grant Mailed Critical | 24 Jul, 2012 | US8227484 |
| Patent Issue Date Used in PTA Calculation Critical | 24 Jul, 2012 | US8227484 |
| Email Notification Critical | 05 Jul, 2012 | US8227484 |
| Issue Notification Mailed Critical | 04 Jul, 2012 | US8227484 |
| Email Notification Critical | 29 Jun, 2012 | US8227484 |
| PG-Pub Issue Notification Critical | 28 Jun, 2012 | US8227484 |
FDA has granted several exclusivities to Nuedexta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Nuedexta, 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 Nuedexta.
Exclusivity Information
Nuedexta holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Nuedexta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Oct 29, 2013 |
US patents provide insights into the exclusivity only within the United States, but Nuedexta 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 Nuedexta's family patents as well as insights into ongoing legal events on those patents.
Nuedexta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nuedexta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 13, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nuedexta Generic API suppliers:
Dextromethorphan Hydrobromide; Quinidine Sulfate is the generic name for the brand Nuedexta. 2 different companies have already filed for the generic of Nuedexta, with Actavis Elizabeth having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Nuedexta's generic
How can I launch a generic of Nuedexta before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Nuedexta's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Nuedexta'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 Nuedexta -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg/10 mg | 07 Mar, 2011 | 1 | 13 Aug, 2026 | Extinguished |
About Nuedexta
Nuedexta is a drug owned by Avanir Pharmaceuticals Inc. It is used for managing symptoms of pseudobulbar affect. Nuedexta uses Dextromethorphan Hydrobromide; Quinidine Sulfate as an active ingredient. Nuedexta was launched by Avanir Pharms in 2010.
Approval Date:
Nuedexta was approved by FDA for market use on 29 October, 2010.
Active Ingredient:
Nuedexta uses Dextromethorphan Hydrobromide; Quinidine Sulfate as the active ingredient. Check out other Drugs and Companies using Dextromethorphan Hydrobromide; Quinidine Sulfate ingredient
Treatment:
Nuedexta is used for managing symptoms of pseudobulbar affect.
Dosage:
Nuedexta is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG;10MG | CAPSULE | Prescription | ORAL |