Keppra is a drug owned by Ucb Inc. It is protected by 2 US drug patents filed in 2014 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 07, 2031. Details of Keppra'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). | |||
| US8802142 | Pharmaceutical compositions comprising levetiracetam and process for their preparation |
Jun, 2031
(6 years from now) | Active |
|
US8802142 (Pediatric) | Pharmaceutical compositions comprising levetiracetam and process for their preparation |
Dec, 2031
(7 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 Keppra's patents.
Latest Legal Activities on Keppra's Patents
Given below is the list of recent legal activities going on the following patents of Keppra.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 26 Jan, 2022 | US8802142 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 01 Feb, 2018 | US8802142 |
| Post Issue Communication - Certificate of Correction | 14 Jul, 2015 | US8802142 |
| Petition Decision - Dismissed | 04 May, 2015 | US8802142 |
| Mail-Petition Decision - Dismissed | 04 May, 2015 | US8802142 |
| Adjustment of PTA Calculation by PTO | 01 May, 2015 | US8802142 |
| Petition Entered | 13 Aug, 2014 | US8802142 |
| Patent Issue Date Used in PTA Calculation | 12 Aug, 2014 | US8802142 |
| Recordation of Patent Grant Mailed | 12 Aug, 2014 | US8802142 |
| Issue Notification Mailed | 23 Jul, 2014 | US8802142 |
FDA has granted several exclusivities to Keppra. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Keppra, 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.
Exclusivity Information
Keppra holds 2 exclusivities. All of its exclusivities have expired in 2015. Details of Keppra's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Dec 16, 2014 |
| Pediatric Exclusivity(PED) | Jun 16, 2015 |
Several oppositions have been filed on Keppra's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Keppra's generic, the next section provides detailed information on ongoing and past EP oppositions related to Keppra patents.
Keppra's oppositions filed in EPO
Keppra has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 09, 2015, by Cooke, Richard. This opposition was filed on patent number EP06776372A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP06776372A | Jun, 2015 | Cooke, Richard | Revoked |
US patents provide insights into the exclusivity only within the United States, but Keppra 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's family patents as well as insights into ongoing legal events on those patents.
Keppra's family patents
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Generic Launch
Generic Release Date:
Keppra's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 07, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Keppra Generics:
Levetiracetam is the generic name for the brand Keppra. 76 different companies have already filed for the generic of Keppra, with Prinston Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Keppra's generic
How can I launch a generic of Keppra before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Keppra's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Keppra'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 -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 250 mg, 500 mg and 750 mg | |||||
| 1000 mg | 24 Jan, 2007 | 1 | 15 Jan, 2009 | 14 Jul, 2008 |
About Keppra
Keppra is a drug owned by Ucb Inc. It is used for treating depression and anxiety. Keppra uses Levetiracetam as an active ingredient. Keppra was launched by Ucb Inc in 1999.
Market Authorisation Date:
Keppra was approved by FDA for market use on 30 November, 1999.
Active Ingredient:
Keppra uses Levetiracetam as the active ingredient. Check out other Drugs and Companies using Levetiracetam ingredient
Treatment:
Keppra is used for treating depression and anxiety.
Dosage:
Keppra is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG | TABLET | Prescription | ORAL |
| 750MG | TABLET | Prescription | ORAL |
| 1GM | TABLET | Prescription | ORAL |
| 250MG | TABLET | Prescription | ORAL |