Briviact is a drug owned by Ucb Inc. It is protected by 4 US drug patents filed from 2016 to 2020. Out of these, 2 drug patents are active and 2 have expired. Briviact's patents have been open to challenges since 12 May, 2020. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 09, 2030. Details of Briviact'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. | |||
| US6911461 | 2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses |
Feb, 2026
(9 months from now) | Active |
| US6784197 | 2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses |
Feb, 2021
(4 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10729653 | Pharmaceutical compositions comprising 2-oxo-1-pyrrolidine derivatives |
Apr, 2030
(4 years from now) | Active |
| US8492416 | 2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses |
Feb, 2021
(4 years ago) |
Expired
|
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 Briviact's patents.
Latest Legal Activities on Briviact's Patents
Given below is the list of recent legal activities going on the following patents of Briviact.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 Jan, 2024 | US10729653 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Jan, 2021 | US8492416 |
| Patent Term Extension Certificate Critical | 27 Oct, 2020 | US6911461 |
| Notice of Final Determination -Eligible | 17 Sep, 2020 | US6911461 |
| Withdrawal of Application for PTE Critical | 11 Sep, 2020 | US8492416 |
| Withdrawal of Application for PTE Critical | 11 Sep, 2020 | US6784197 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 10 Sep, 2020 | US6911461 |
| Patent Issue Date Used in PTA Calculation Critical | 04 Aug, 2020 | US10729653 |
| Recordation of Patent Grant Mailed Critical | 04 Aug, 2020 | US10729653 |
| Requirement for information sent under 37 CFR 1.750 | 03 Aug, 2020 | US6911461 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Briviact and ongoing litigations to help you estimate the early arrival of Briviact generic.
Briviact's Litigations
Briviact been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Nov 27, 2018, against patent number US10729653. The petitioner , challenged the validity of this patent, with Serge Cuypers et al as the respondent. Click below to track the latest information on how companies are challenging Briviact's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10729653 | November, 2018 |
Decision
(27 Jun, 2019) | Serge Cuypers et al | |
FDA has granted some exclusivities to Briviact. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Briviact, 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 Briviact.
Exclusivity Information
Briviact holds 2 exclusivities. All of its exclusivities have expired in 2024. Details of Briviact's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 12, 2021 |
| New Patient Population(NPP) | Aug 27, 2024 |
US patents provide insights into the exclusivity only within the United States, but Briviact 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 Briviact's family patents as well as insights into ongoing legal events on those patents.
Briviact's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Briviact's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 09, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Briviact Generic API suppliers:
Brivaracetam is the generic name for the brand Briviact. 4 different companies have already filed for the generic of Briviact, with Lupin Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Briviact's generic
How can I launch a generic of Briviact before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Briviact's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Briviact'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 Briviact -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 50 mg/5 mL | 12 May, 2020 | 2 | 21 Feb, 2026 | ||
| 10 mg/mL | 12 May, 2020 | 1 | 21 Feb, 2026 | ||
| 10 mg, 25 mg, 50 mg, 75 mg and 100 mg | 12 May, 2020 | 7 | 09 Jun, 2022 | 21 Feb, 2026 | Eligible |
About Briviact
Briviact is a drug owned by Ucb Inc. It is used for managing partial-onset seizures in patients with epilepsy aged 4 years and older. Briviact uses Brivaracetam as an active ingredient. Briviact was launched by Ucb Inc in 2016.
Approval Date:
Briviact was approved by FDA for market use on 12 May, 2016.
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 Briviact is 12 May, 2016, its NCE-1 date is estimated to be 12 May, 2020.
Active Ingredient:
Briviact uses Brivaracetam as the active ingredient. Check out other Drugs and Companies using Brivaracetam ingredient
Treatment:
Briviact is used for managing partial-onset seizures in patients with epilepsy aged 4 years and older.
Dosage:
Briviact is available in the following dosage forms - solution form for oral use, tablet form for oral use, solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG | TABLET | Prescription | ORAL |
| 50MG | TABLET | Prescription | ORAL |
| 100MG | TABLET | Prescription | ORAL |
| 25MG | TABLET | Prescription | ORAL |
| 75MG | TABLET | Prescription | ORAL |
| 10MG/ML | SOLUTION | Prescription | ORAL |
| 50MG/5ML (10MG/ML) | SOLUTION | Prescription | INTRAVENOUS |