Trileptal is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 4 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 19, 2021. Details of Trileptal'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). | |||
|
US8119148 (Pediatric) | Suspension comprising oxcarbazepine |
Jun, 2021
(3 years ago) |
Expired
|
| US8119148 | Suspension comprising oxcarbazepine |
Dec, 2020
(4 years ago) |
Expired
|
|
US7037525 (Pediatric) | Oxacarbazepine film-coated tablets |
Aug, 2018
(6 years ago) |
Expired
|
| US7037525 | Oxacarbazepine film-coated tablets |
Feb, 2018
(6 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 Trileptal's patents.
Latest Legal Activities on Trileptal's Patents
Given below is the list of recent legal activities going on the following patents of Trileptal.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 25 Mar, 2024 | US8119148 |
| Maintenance Fee Reminder Mailed Critical | 09 Oct, 2023 | US8119148 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 08 Aug, 2019 | US8119148 |
| Expire Patent Critical | 30 May, 2014 | US7037525 |
| Recordation of Patent Grant Mailed Critical | 21 Feb, 2012 | US8119148 |
| Patent Issue Date Used in PTA Calculation Critical | 21 Feb, 2012 | US8119148 |
| Issue Notification Mailed Critical | 01 Feb, 2012 | US8119148 |
| Dispatch to FDC | 27 Jan, 2012 | US8119148 |
| Dispatch to FDC | 17 Jan, 2012 | US8119148 |
| Application Is Considered Ready for Issue Critical | 17 Jan, 2012 | US8119148 |
US patents provide insights into the exclusivity only within the United States, but Trileptal 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 Trileptal's family patents as well as insights into ongoing legal events on those patents.
Trileptal's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Trileptal's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 19, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Trileptal Generic API suppliers:
Oxcarbazepine is the generic name for the brand Trileptal. 23 different companies have already filed for the generic of Trileptal, with Rubicon having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Trileptal's generic
How can I launch a generic of Trileptal before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Trileptal's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Trileptal'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 Trileptal -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 150 mg, 300 mg and 600 mg | 05 May, 2006 | 1 | 09 Oct, 2007 | 12 Feb, 2018 | Eligible |
| 300 mg/5 mL | 26 Dec, 2006 | 1 | 26 Jun, 2009 | 12 Feb, 2018 | Eligible |
Alternative Brands for Trileptal
Trileptal which is used for managing seizures., has several other brand drugs in the same treatment category and using the same active ingredient (Oxcarbazepine). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Otter Pharms |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Oxcarbazepine. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Supernus Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Oxcarbazepine, Trileptal's active ingredient. Check the complete list of approved generic manufacturers for Trileptal
About Trileptal
Trileptal is a drug owned by Novartis Pharmaceuticals Corp. It is used for managing seizures. Trileptal uses Oxcarbazepine as an active ingredient. Trileptal was launched by Novartis in 2001.
Approval Date:
Trileptal was approved by FDA for market use on 25 May, 2001.
Active Ingredient:
Trileptal uses Oxcarbazepine as the active ingredient. Check out other Drugs and Companies using Oxcarbazepine ingredient
Treatment:
Trileptal is used for managing seizures.
Dosage:
Trileptal is available in the following dosage forms - tablet form for oral use, suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 300MG/5ML | SUSPENSION | Prescription | ORAL |
| 600MG | TABLET | Prescription | ORAL |
| 150MG | TABLET | Prescription | ORAL |
| 300MG | TABLET | Prescription | ORAL |