Trokendi Xr Patent Expiration

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
US8663683 Sustained-release formulations of topiramate
Nov, 2027

(3 years from now)

Active
US10314790 Sustained-release formulations of topiramate
Nov, 2027

(3 years from now)

Active
US9622983 Sustained-release formulations of topiramate
Nov, 2027

(3 years from now)

Active
US9549940 Sustained-release formulations of topiramate
Nov, 2027

(3 years from now)

Active
US8877248 Sustained-release formulations of topiramate
Nov, 2027

(3 years from now)

Active
US8992989 Sustained-release formulations of topiramate
Nov, 2027

(3 years from now)

Active
US8298580 Sustained-release formulations of topiramate
Nov, 2027

(3 years from now)

Active
US8889191 Sustained-release formulations of topiramate
Nov, 2027

(3 years from now)

Active
US9555004 Sustained-release formulations of topiramate
Nov, 2027

(3 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.

Given below is the list of recent legal activities going on the following patents of Trokendi Xr.

Activity Date Patent Number
Patent litigations
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 11 Jun, 2019 US10314790 (Litigated)
Recordation of Patent Grant Mailed 11 Jun, 2019 US10314790 (Litigated)

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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

Trokendi Xr has patent protection in a total of 8 countries. It has a significant patent presence in the US with 57.1% of its patents being US patents. Click below to unlock the full patent family tree for Trokendi Xr.

Family Patents

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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. 35 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
Depakote Er Used for managing and preventing seizures in epilepsy and sometimes used for treating migraine headaches.
Catalyst Pharms
Fycompa used for controlling seizures in patients with epilepsy.
Eisai Inc
Banzel Used for managing and treating epilepsy.

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
Eprontia
Janssen Pharms
Topamax
Topamax Sprinkle
Upsher Smith Labs
Qudexy Xr
Vivus Llc
Qsymia


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
200MG CAPSULE, EXTENDED RELEASE Prescription ORAL
50MG CAPSULE, EXTENDED RELEASE Prescription ORAL
25MG CAPSULE, EXTENDED RELEASE Prescription ORAL