Keppra Xr is a drug owned by Ucb Inc. It is protected by 1 US drug patent filed in 2013 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 17, 2028. Details of Keppra 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). | |||
| US7858122 | Extended release formulation of levetiracetam |
Sep, 2028
(1 year, 11 months 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 Keppra Xr's patents.
Latest Legal Activities on Keppra Xr's Patents
Given below is the list of recent legal activities going on the following patents of Keppra Xr.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 15 Jun, 2022 | US7858122 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Jun, 2018 | US7858122 |
| Post Issue Communication - Certificate of Correction | 14 Jan, 2011 | US7858122 |
| Patent Issue Date Used in PTA Calculation
Critical | 28 Dec, 2010 | US7858122 |
| Recordation of Patent Grant Mailed
Critical | 28 Dec, 2010 | US7858122 |
| Issue Notification Mailed
Critical | 08 Dec, 2010 | US7858122 |
| Dispatch to FDC | 29 Nov, 2010 | US7858122 |
| Application Is Considered Ready for Issue
Critical | 15 Nov, 2010 | US7858122 |
| Issue Fee Payment Received
Critical | 09 Nov, 2010 | US7858122 |
| Issue Fee Payment Verified
Critical | 09 Nov, 2010 | US7858122 |
FDA has granted several exclusivities to Keppra Xr. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Keppra 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
Keppra Xr.
Exclusivity Information
Keppra Xr holds 1 exclusivities. All of its exclusivities have expired in 2011. Details of Keppra Xr's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Sep 12, 2011 |
US patents provide insights into the exclusivity only within the United States, but
Keppra 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 Keppra Xr's family patents as well as insights into
ongoing legal events
on those patents.
Keppra Xr's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Keppra Xr:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Keppra Xr's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 17, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Keppra Xr Generic API suppliers:
Levetiracetam is the generic name for the brand Keppra Xr. 78 different companies have already filed for the generic of Keppra Xr, with Prinston Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Keppra Xr's generic
How can I launch a generic of Keppra Xr before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Keppra Xr's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Keppra 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 Keppra Xr -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 07 Jan, 2011 | 17 Sep, 2028 | Eligible | 12 Sep, 2011 | Moderate | |
| 07 Jan, 2011 | 17 Sep, 2028 | Extinguished | Less |
Alternative Brands for Keppra Xr
There are several other brand drugs using the same active ingredient (Levetiracetam) as Keppra Xr. 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 | |
|---|---|---|
| Aprecia Pharms |
| |
| Tripoint |
| |
| Ucb Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Levetiracetam, Keppra Xr's active ingredient. Check the complete list of approved generic manufacturers for Keppra Xr
About Keppra Xr
Keppra Xr is a drug owned by Ucb Inc. Keppra Xr uses Levetiracetam as an active ingredient. Keppra Xr was launched by Ucb in 2008.
Approval Date:
Keppra Xr was approved by FDA for market use on 12 September, 2008.
Active Ingredient:
Keppra Xr uses Levetiracetam as the active ingredient. Check out other Drugs and Companies using Levetiracetam ingredient
Dosage:
Keppra Xr is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |
| 750MG | TABLET, EXTENDED RELEASE | Prescription | ORAL |