Xcopri is a drug owned by Sk Life Science Inc. It is protected by 2 US drug patents filed from 2020 to 2023 out of which none have expired yet. Xcopri's patents have been open to challenges since 10 March, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 16, 2039. Details of Xcopri's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7598279 | Neurotherapeutic azole compounds |
Oct, 2032
(7 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11654133 | Use of [(1R)-1-(2-chlorophenyl)-2-(tetrazol-2-yl)ethyl] carbamate in combination therapy |
Jun, 2039
(14 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 Xcopri's patents.
Latest Legal Activities on Xcopri's Patents
Given below is the list of recent legal activities going on the following patents of Xcopri.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Electronic Review Critical | 07 Jun, 2024 | US7598279 |
| Mail Pub Notice re 312 amendment | 20 Mar, 2024 | US7598279 |
| Email Notification Critical | 20 Mar, 2024 | US7598279 |
| Post Issue Communication - Certificate of Correction Denied | 15 Mar, 2024 | US7598279 |
| POST ISSUE OTHER COMMUNICATION TO APPLICANT- CERTIFICATE OF CORRECTION | 14 Mar, 2024 | US7598279 |
| Patent Term Extension Certificate Critical | 09 Nov, 2023 | US7598279 |
| Notice of Final Determination -Eligible | 09 Aug, 2023 | US7598279 |
| FDA Final Eligibility Letter Critical | 13 Jul, 2023 | US7598279 |
| Patent Issue Date Used in PTA Calculation Critical | 23 May, 2023 | US11654133 |
| Recordation of Patent eGrant | 23 May, 2023 | US11654133 |
FDA has granted several exclusivities to Xcopri. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xcopri, 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 Xcopri.
Exclusivity Information
Xcopri holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Xcopri's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 10, 2025 |
US patents provide insights into the exclusivity only within the United States, but Xcopri 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 Xcopri's family patents as well as insights into ongoing legal events on those patents.
Xcopri's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xcopri's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 16, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xcopri Generics:
There are no approved generic versions for Xcopri as of now.
About Xcopri
Xcopri is a drug owned by Sk Life Science Inc. It is used for treating partial onset seizures through co-administration with phenobarbital and/or phenytoin. Xcopri uses Cenobamate as an active ingredient. Xcopri was launched by Sk Life in 2020.
Approval Date:
Xcopri was approved by FDA for market use on 10 March, 2020.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Xcopri is 10 March, 2020, its NCE-1 date is estimated to be 10 March, 2024.
Active Ingredient:
Xcopri uses Cenobamate as the active ingredient. Check out other Drugs and Companies using Cenobamate ingredient
Treatment:
Xcopri is used for treating partial onset seizures through co-administration with phenobarbital and/or phenytoin.
Dosage:
Xcopri is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25MG | TABLET | Prescription | ORAL |
| 12.5MG | TABLET | Prescription | ORAL |
| 200MG | TABLET | Prescription | ORAL |
| 150MG | TABLET | Prescription | ORAL |
| 100MG | TABLET | Prescription | ORAL |
| 50MG | TABLET | Prescription | ORAL |