Qudexy Xr is a drug owned by Upsher Smith Laboratories Llc. It is protected by 5 US drug patents filed from 2014 to 2019 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 19, 2033. Details of Qudexy 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). | |||
| US10363224 | Extended-release topiramate capsules |
Mar, 2033
(8 years from now) | Active |
| US9555005 | Extended-release topiramate capsules |
Mar, 2033
(8 years from now) | Active |
| US9101545 | Extended-release topiramate capsules |
Mar, 2033
(8 years from now) | Active |
| US8889190 | Extended-release topiramate capsules |
Mar, 2033
(8 years from now) | Active |
| US8652527 | Extended-release topiramate capsules |
Mar, 2033
(8 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 Qudexy Xr's patents.
Latest Legal Activities on Qudexy Xr's Patents
Given below is the list of recent legal activities going on the following patents of Qudexy Xr.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Feb, 2023 | US9101545 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 Jan, 2023 | US10363224 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 May, 2022 | US8889190 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Aug, 2021 | US8652527 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 31 Jul, 2020 | US9555005 |
| Recordation of Patent Grant Mailed | 30 Jul, 2019 | US10363224 |
| Patent Issue Date Used in PTA Calculation | 30 Jul, 2019 | US10363224 |
| Email Notification | 11 Jul, 2019 | US10363224 |
| Issue Notification Mailed | 10 Jul, 2019 | US10363224 |
| Dispatch to FDC | 26 Jun, 2019 | US10363224 |
US patents provide insights into the exclusivity only within the United States, but Qudexy 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 Qudexy Xr's family patents as well as insights into ongoing legal events on those patents.
Qudexy Xr's family patents
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Generic Launch
Generic Release Date:
Qudexy Xr's generic launch date based on the expiry of its last outstanding patent is estimated to be Mar 19, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Qudexy Xr Generics:
Topiramate is the generic name for the brand Qudexy Xr. 34 different companies have already filed for the generic of Qudexy 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 Qudexy Xr's generic
How can I launch a generic of Qudexy Xr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Qudexy Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Qudexy 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 Qudexy Xr -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg | 24 Dec, 2015 | 1 | 19 Mar, 2033 | Extinguished Non-Forfeiture |
About Qudexy Xr
Qudexy Xr is a drug owned by Upsher Smith Laboratories Llc. It is used for managing and controlling seizures. Qudexy Xr uses Topiramate as an active ingredient. Qudexy Xr was launched by Upsher Smith Labs in 2014.
Market Authorisation Date:
Qudexy Xr was approved by FDA for market use on 11 March, 2014.
Active Ingredient:
Qudexy Xr uses Topiramate as the active ingredient. Check out other Drugs and Companies using Topiramate ingredient
Treatment:
Qudexy Xr is used for managing and controlling seizures.
Dosage:
Qudexy Xr is available in capsule, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 200MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 50MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 150MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |
| 100MG | CAPSULE, EXTENDED RELEASE | Prescription | ORAL |