Qudexy Xr Patent Expiration

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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10363224 Extended-release topiramate capsules
Mar, 2033

(8 years from now)

Active
US8889190 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
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.

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

Activity Date Patent Number
Patent litigations
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

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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

Qudexy Xr has patent protection in a total of 6 countries. It has a significant patent presence in the US with 63.2% of its patents being US patents. 3 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Qudexy Xr.

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 Generic API suppliers:

Topiramate is the generic name for the brand Qudexy Xr. 35 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

Alternative Brands for Qudexy Xr

Qudexy Xr which is used for managing and controlling seizures., 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
Janssen Pharms
Topamax

(uses Topiramate)

Used for preventing migraines and treating seizures.
Topamax Sprinkle

(uses Topiramate)

Used for preventing migraines and treating seizures.

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
Supernus Pharms
Trokendi Xr
Vivus Llc
Qsymia


Apart from brand drugs containing the same ingredient, some generics have also been filed for Topiramate, Qudexy Xr's active ingredient. Check the complete list of approved generic manufacturers for Qudexy Xr





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.

Approval 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
50MG CAPSULE, EXTENDED RELEASE Prescription ORAL
100MG CAPSULE, EXTENDED RELEASE Prescription ORAL
150MG CAPSULE, EXTENDED RELEASE Prescription ORAL
25MG CAPSULE, EXTENDED RELEASE Prescription ORAL
200MG CAPSULE, EXTENDED RELEASE Prescription ORAL