Trokendi Xr is a drug owned by Supernus Pharmaceuticals Inc. It is protected by 10 US drug patents filed from 2013 to 2019 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 04, 2028. Details of Trokendi 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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8298576 | Sustained-release formulations of topiramate |
Apr, 2028
(3 years from now) | Active |
| US8298580 | Sustained-release formulations of topiramate |
Nov, 2027
(2 years from now) | Active |
| US8992989 | Sustained-release formulations of topiramate |
Nov, 2027
(2 years from now) | Active |
| US8663683 | Sustained-release formulations of topiramate |
Nov, 2027
(2 years from now) | Active |
| US8889191 | Sustained-release formulations of topiramate |
Nov, 2027
(2 years from now) | Active |
| US9549940 | Sustained-release formulations of topiramate |
Nov, 2027
(2 years from now) | Active |
| US9622983 | Sustained-release formulations of topiramate |
Nov, 2027
(2 years from now) | Active |
| US9555004 | Sustained-release formulations of topiramate |
Nov, 2027
(2 years from now) | Active |
| US10314790 | Sustained-release formulations of topiramate |
Nov, 2027
(2 years from now) | Active |
| US8877248 | Sustained-release formulations of topiramate |
Nov, 2027
(2 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 Trokendi Xr's patents.
Latest Legal Activities on Trokendi Xr's Patents
Given below is the list of recent legal activities going on the following patents of Trokendi Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 30 Apr, 2024 | US8298580 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Dec, 2022 | US10314790 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 May, 2022 | US8889191 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 04 May, 2022 | US8877248 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 19 Oct, 2020 | US9622983 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 31 Jul, 2020 | US9555004 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 24 Jul, 2020 | US9549940 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Apr, 2020 | US8298580 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 11 Jun, 2019 | US10314790 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 11 Jun, 2019 | US10314790 (Litigated) |
US patents provide insights into the exclusivity only within the United States, but Trokendi 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 Trokendi Xr's family patents as well as insights into ongoing legal events on those patents.
Trokendi Xr's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Trokendi Xr's generic launch date based on the expiry of its last outstanding patent is estimated to be Apr 04, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Trokendi Xr Generic API suppliers:
Topiramate is the generic name for the brand Trokendi Xr. 38 different companies have already filed for the generic of Trokendi Xr, with Glenmark Pharms Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Trokendi Xr's generic
How can I launch a generic of Trokendi Xr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Trokendi Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Trokendi 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 Trokendi Xr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 200 mg | 03 Apr, 2014 | 1 | 18 Mar, 2029 | Extinguished | |
| 25 mg, 50 mg, and 100 mg | 12 May, 2014 | 1 | 24 Nov, 2017 | 18 Mar, 2029 | Extinguished Non-Forfeiture Deferred |
Alternative Brands for Trokendi Xr
Trokendi Xr which is used for managing epilepsy and preventing migraines., has several other brand drugs in the same treatment category and using the same active ingredient (Topiramate). 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 | ||
|---|---|---|---|---|
| Abbvie |
| |||
| Catalyst Pharms |
| |||
| Eisai Inc |
| |||
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. Topiramate. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Azurity |
| ||
| Janssen Pharms |
| ||
| Upsher Smith Labs |
| ||
| Vivus Llc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Topiramate, Trokendi Xr's active ingredient. Check the complete list of approved generic manufacturers for Trokendi Xr
About Trokendi Xr
Trokendi Xr is a drug owned by Supernus Pharmaceuticals Inc. It is used for managing epilepsy and preventing migraines. Trokendi Xr uses Topiramate as an active ingredient. Trokendi Xr was launched by Supernus Pharms in 2013.
Approval Date:
Trokendi Xr was approved by FDA for market use on 16 August, 2013.
Active Ingredient:
Trokendi Xr uses Topiramate as the active ingredient. Check out other Drugs and Companies using Topiramate ingredient
Treatment:
Trokendi Xr is used for managing epilepsy and preventing migraines.
Dosage:
Trokendi Xr is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 50MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 200MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 25MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |