Bepreve is a drug owned by Bausch And Lomb Inc. It is protected by 3 US drug patents filed from 2013 to 2014. Out of these, 1 drug patents are active and 2 have expired. Bepreve's patents have been open to challenges since 08 September, 2013. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 13, 2025. Details of Bepreve'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). | |||
| US8784789 | Aqueous liquid preparations and light-stabilized aqueous liquid preparations |
Jan, 2025
(a month from now) | Active |
| US8877168 | Aqueous liquid preparations and light-stabilized aqueous liquid preparations |
Jul, 2023
(1 year, 3 months ago) |
Expired
|
| US6780877 | Acid addition salt of optically active piperidine compound and process for preparing the same |
Sep, 2019
(5 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 Bepreve's patents.
Latest Legal Activities on Bepreve's Patents
Given below is the list of recent legal activities going on the following patents of Bepreve.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Mar, 2022 | US8877168 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 05 Jan, 2022 | US8784789 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 11 Apr, 2018 | US8877168 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 04 Jan, 2018 | US8784789 (Litigated) |
| Termination or Final Written Decision | 14 Nov, 2016 | US8877168 |
| Termination or Final Written Decision | 31 Aug, 2016 | US8784789 (Litigated) |
| Petition Requesting Trial | 16 Jun, 2016 | US8877168 |
| Petition Requesting Trial | 06 Jun, 2016 | US8877168 |
| Petition Requesting Trial | 25 Feb, 2016 | US8784789 (Litigated) |
| Application ready for PDX access by participating foreign offices Critical | 31 Aug, 2015 | US8877168 |
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 Bepreve and ongoing litigations to help you estimate the early arrival of Bepreve generic.
Bepreve's Litigations
Bepreve been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 25, 2016, against patent number US8784789. The petitioner Mylan Pharmaceuticals, Inc., challenged the validity of this patent, with Senju Pharmaceutical Co. Ltd. as the respondent. Click below to track the latest information on how companies are challenging Bepreve's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8877168 | June, 2016 |
Terminated-Settled
(14 Nov, 2016) | Senju Pharmaceuticals Co., Ltd. | Mylan Pharmaceuticals, Inc. |
| US8784789 | February, 2016 |
Terminated-Settled
(31 Aug, 2016) | Senju Pharmaceutical Co. Ltd. | Mylan Pharmaceuticals, Inc. |
FDA has granted some exclusivities to Bepreve. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Bepreve, 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 Bepreve.
Exclusivity Information
Bepreve holds 1 exclusivities. All of its exclusivities have expired in 2014. Details of Bepreve's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 08, 2014 |
US patents provide insights into the exclusivity only within the United States, but Bepreve 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 Bepreve's family patents as well as insights into ongoing legal events on those patents.
Bepreve's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Bepreve's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 13, 2025 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Bepreve Generic API suppliers:
Bepotastine Besilate is the generic name for the brand Bepreve. 4 different companies have already filed for the generic of Bepreve, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Bepreve's generic
How can I launch a generic of Bepreve before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Bepreve's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Bepreve'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 Bepreve -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.015 | 09 Sep, 2013 | 3 | 05 Mar, 2019 | 19 Sep, 2019 | Extinguished Deferred |
About Bepreve
Bepreve is a drug owned by Bausch And Lomb Inc. Bepreve uses Bepotastine Besilate as an active ingredient. Bepreve was launched by Bausch And Lomb Inc in 2009.
Approval Date:
Bepreve was approved by FDA for market use on 08 September, 2009.
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 Bepreve is 08 September, 2009, its NCE-1 date is estimated to be 08 September, 2013.
Active Ingredient:
Bepreve uses Bepotastine Besilate as the active ingredient. Check out other Drugs and Companies using Bepotastine Besilate ingredient
Dosage:
Bepreve is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.5% | SOLUTION/DROPS | Prescription | OPHTHALMIC |