Banzel is a drug owned by Eisai Inc. It is protected by 6 US drug patents filed from 2013 to 2014 out of which all have expired. Banzel's patents have been open to challenges since 15 May, 2015. Based on its patents and exclusivities, its generic launch date is estimated to be May 14, 2023. Details of Banzel'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). | |||
|
US6740669 (Pediatric) | Crystal modification of 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxamide and its use as antiepileptic |
May, 2023
(1 year, 11 months ago) |
Expired
|
| US6740669 | Crystal modification of 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxamide and its use as antiepileptic |
Nov, 2022
(2 years ago) |
Expired
|
|
US7750028 (Pediatric) | Crystal modifications of 1-(2,6-difluorobenzyl)-1H-1, 2,3-triazole-4-carboxamide |
Apr, 2019
(6 years ago) |
Expired
|
|
US8076362 (Pediatric) | Crystal modification A of 1-(2,6-difluorobenzyI)-1 H-1,2,3-triazole-4-carboxamide and dosage forms and formulations thereof |
Dec, 2018
(6 years ago) |
Expired
|
| US7750028 | Crystal modifications of 1-(2,6-difluorobenzyl)-1H-1, 2,3-triazole-4-carboxamide |
Oct, 2018
(6 years ago) |
Expired
|
| US8076362 | Crystal modification A of 1-(2,6-difluorobenzyI)-1 H-1,2,3-triazole-4-carboxamide and dosage forms and formulations thereof |
Jun, 2018
(6 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 Banzel's patents.
Latest Legal Activities on Banzel's Patents
Given below is the list of recent legal activities going on the following patents of Banzel.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 08 Aug, 2022 | US7750028 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 21 Feb, 2022 | US7750028 (Litigated) |
| Expire Patent Critical | 20 Jan, 2020 | US8076362 |
| Maintenance Fee Reminder Mailed Critical | 05 Aug, 2019 | US8076362 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Dec, 2017 | US7750028 (Litigated) |
| Post Issue Communication - Certificate of Correction | 15 Sep, 2014 | US7750028 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 13 Dec, 2011 | US8076362 |
| Patent Issue Date Used in PTA Calculation Critical | 13 Dec, 2011 | US8076362 |
| Issue Notification Mailed Critical | 22 Nov, 2011 | US8076362 |
| Application Is Considered Ready for Issue Critical | 10 Nov, 2011 | US8076362 |
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 Banzel and ongoing litigations to help you estimate the early arrival of Banzel generic.
Banzel's Litigations
Banzel been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 22, 2003, against patent number US6740669. The petitioner , challenged the validity of this patent, with ROBERT PORTMANN et al as the respondent. Click below to track the latest information on how companies are challenging Banzel's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6740669 | April, 2003 |
Decision
(17 Nov, 2003) | ROBERT PORTMANN et al | |
FDA has granted some exclusivities to Banzel. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Banzel, 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 Banzel.
Exclusivity Information
Banzel holds 3 exclusivities. All of its exclusivities have expired in 2016. Details of Banzel's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 14, 2013 |
| Orphan Drug Exclusivity(ODE) | Nov 14, 2015 |
| Pediatric Exclusivity(PED) | May 14, 2016 |
US patents provide insights into the exclusivity only within the United States, but Banzel 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 Banzel's family patents as well as insights into ongoing legal events on those patents.
Banzel's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Banzel's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 14, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Banzel Generic API suppliers:
Rufinamide is the generic name for the brand Banzel. 10 different companies have already filed for the generic of Banzel, with Lupin Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Banzel's generic
How can I launch a generic of Banzel before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Banzel's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Banzel'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 Banzel -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 100 mg | 14 Nov, 2012 | 1 | 17 Aug, 2022 | 14 Nov, 2022 | Extinguished Deferred |
| 200 mg and 400 mg | 14 Nov, 2012 | 5 | 16 May, 2016 | 14 Nov, 2022 | Eligible |
| 40 mg/mL | 16 Jun, 2014 | 1 | 14 Nov, 2022 | Extinguished |
Alternative Brands for Banzel
Banzel which is used for managing and treating epilepsy., has several other brand drugs in the same treatment category . 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 | ||
|---|---|---|---|---|
| Abbvie |
| |||
| Catalyst Pharms |
| |||
| Supernus Pharms |
| |||
About Banzel
Banzel is a drug owned by Eisai Inc. It is used for managing and treating epilepsy. Banzel uses Rufinamide as an active ingredient. Banzel was launched by Eisai Inc in 2008.
Approval Date:
Banzel was approved by FDA for market use on 14 November, 2008.
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 Banzel is 14 November, 2008, its NCE-1 date is estimated to be 15 May, 2015.
Active Ingredient:
Banzel uses Rufinamide as the active ingredient. Check out other Drugs and Companies using Rufinamide ingredient
Treatment:
Banzel is used for managing and treating epilepsy.
Dosage:
Banzel is available in the following dosage forms - suspension form for oral use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG | TABLET | Prescription | ORAL |
| 400MG | TABLET | Prescription | ORAL |
| 40MG/ML | SUSPENSION | Prescription | ORAL |
| 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |