Oxtellar Xr Patent Expiration

Oxtellar Xr is a drug owned by Supernus Pharmaceuticals Inc. It is protected by 11 US drug patents filed from 2013 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 13, 2027. Details of Oxtellar 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).
US10220042 Modified release preparations containing oxcarbazepine and derivatives thereof
Apr, 2027

(2 years from now)

Active
US7910131 Method of treating seizures using modified release formulations of oxcarbazepine
Apr, 2027

(2 years from now)

Active
US9119791 Modified release preparations containing oxcarbazepine and derivatives thereof
Apr, 2027

(2 years from now)

Active
US11896599 Modified release preparations containing oxcarbazepine and derivatives thereof
Apr, 2027

(2 years from now)

Active
US11166960 Modified release preparations containing oxcarbazepine and derivatives thereof
Apr, 2027

(2 years from now)

Active
US9855278 Modified release preparations containing oxcarbazepine and derivatives thereof
Apr, 2027

(2 years from now)

Active
US7722898 Modified-release preparations containing oxcarbazepine and derivatives thereof
Apr, 2027

(2 years from now)

Active
US9370525 Modified release preparations containing oxcarbazepine and derivatives thereof
Apr, 2027

(2 years from now)

Active
US8821930 Modified release preparations containing oxcarbazepine and derivatives thereof
Apr, 2027

(2 years from now)

Active
US8617600 Modified release preparations containing oxcarbazepine and derivatives thereof
Apr, 2027

(2 years from now)

Active
US9351975 Modified release preparations containing oxcarbazepine and derivatives thereof
Apr, 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 Oxtellar Xr's patents.

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

Activity Date Patent Number
Patent litigations
Patent eGrant Notification 13 Feb, 2024 US11896599
Patent Issue Date Used in PTA Calculation 13 Feb, 2024 US11896599
Recordation of Patent Grant Mailed 13 Feb, 2024 US11896599
Recordation of Patent eGrant 13 Feb, 2024 US11896599
Mail Patent eGrant Notification 13 Feb, 2024 US11896599
Email Notification 13 Feb, 2024 US11896599
Email Notification 25 Jan, 2024 US11896599
Issue Notification Mailed 24 Jan, 2024 US11896599
Application Is Considered Ready for Issue 16 Jan, 2024 US11896599
Dispatch to FDC 16 Jan, 2024 US11896599


FDA has granted several exclusivities to Oxtellar Xr. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Oxtellar Xr, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Oxtellar Xr.

Exclusivity Information

Oxtellar Xr holds 1 exclusivities. All of its exclusivities have expired in 2015. Details of Oxtellar Xr's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Dosage Form(NDF) Oct 19, 2015

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US patents provide insights into the exclusivity only within the United States, but Oxtellar 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 Oxtellar Xr's family patents as well as insights into ongoing legal events on those patents.

Oxtellar Xr's Family Patents

Oxtellar Xr has patent protection in a total of 10 countries. It has a significant patent presence in the US with 60.0% of its patents being US patents. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Oxtellar Xr.

Family Patents

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Generic Launch

Generic Release Date:

Oxtellar Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 13, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Oxtellar Xr Generic API suppliers:

Oxcarbazepine is the generic name for the brand Oxtellar Xr. 22 different companies have already filed for the generic of Oxtellar Xr, with Rubicon having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Oxtellar Xr's generic

How can I launch a generic of Oxtellar Xr before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Oxtellar Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Oxtellar 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 Oxtellar Xr -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
600 mg 20 Mar, 2013 1 13 Apr, 2027 Extinguished
150 mg and 300 mg 12 Apr, 2013 1 13 Apr, 2027 Extinguished

Alternative Brands for Oxtellar Xr

Oxtellar Xr which is used for managing partial-onset 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
Sumitomo Pharma Am
Aptiom Used for managing partial-onset seizures and absence seizures in patients with 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. Oxcarbazepine. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Novartis
Trileptal


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





About Oxtellar Xr

Oxtellar Xr is a drug owned by Supernus Pharmaceuticals Inc. It is used for managing partial-onset seizures. Oxtellar Xr uses Oxcarbazepine as an active ingredient. Oxtellar Xr was launched by Supernus Pharms in 2012.

Approval Date:

Oxtellar Xr was approved by FDA for market use on 19 October, 2012.

Active Ingredient:

Oxtellar Xr uses Oxcarbazepine as the active ingredient. Check out other Drugs and Companies using Oxcarbazepine ingredient

Treatment:

Oxtellar Xr is used for managing partial-onset seizures.

Dosage:

Oxtellar Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
150MG TABLET, EXTENDED RELEASE Prescription ORAL
600MG TABLET, EXTENDED RELEASE Prescription ORAL
300MG TABLET, EXTENDED RELEASE Prescription ORAL