Besivance is a drug owned by Bausch And Lomb Inc. It is protected by 7 US drug patents filed from 2013 to 2015. Out of these, 4 drug patents are active and 3 have expired. Besivance's patents have been open to challenges since 28 May, 2013. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 09, 2031. Details of Besivance'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. | |||
| US8481526 | Fluoroquinolone carboxylic acid molecular crystals |
Jan, 2031
(6 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). | |||
| US8415342 | Besifloxacin ophthalmic composition for the treatment or control of infection |
Nov, 2030
(5 years from now) | Active |
| US8604020 | Fluoroquinolone carboxylic acid molecular crystals |
Mar, 2030
(5 years from now) | Active |
| US8937062 | Compositions and methods for treating, reducing, ameliorating, or preventing infections caused by antibacterial drug-resistant bacteria |
Nov, 2029
(4 years from now) | Active |
| US6685958 | Quinolone carboxylic acid compositions and related methods of treatment |
Jun, 2021
(3 years ago) |
Expired
|
| US6699492 | Quinolone carboxylic acid compositions and related methods of treatment |
Mar, 2019
(5 years ago) |
Expired
|
| US5447926 | Quinolone carboxylic acid derivatives |
Apr, 2016
(8 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 Besivance's patents.
Latest Legal Activities on Besivance's Patents
Given below is the list of recent legal activities going on the following patents of Besivance.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Jun, 2022 | US8937062 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 25 May, 2021 | US8604020 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 04 Jan, 2021 | US8481526 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Sep, 2020 | US8415342 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Jun, 2018 | US8937062 |
| Patent Issue Date Used in PTA Calculation Critical | 20 Jan, 2015 | US8937062 |
| Recordation of Patent Grant Mailed Critical | 20 Jan, 2015 | US8937062 |
| Email Notification Critical | 31 Dec, 2014 | US8937062 |
| Issue Notification Mailed Critical | 30 Dec, 2014 | US8937062 |
| Application Is Considered Ready for Issue Critical | 18 Dec, 2014 | US8937062 |
FDA has granted several exclusivities to Besivance. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Besivance, 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 Besivance.
Exclusivity Information
Besivance holds 1 exclusivities. All of its exclusivities have expired in 2014. Details of Besivance's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 28, 2014 |
US patents provide insights into the exclusivity only within the United States, but Besivance 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 Besivance's family patents as well as insights into ongoing legal events on those patents.
Besivance's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Besivance's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 09, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Besivance Generics:
There are no approved generic versions for Besivance as of now.
About Besivance
Besivance is a drug owned by Bausch And Lomb Inc. It is used for treating ocular bacterial infections. Besivance uses Besifloxacin Hydrochloride as an active ingredient. Besivance was launched by Bausch And Lomb in 2009.
Approval Date:
Besivance was approved by FDA for market use on 28 May, 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 Besivance is 28 May, 2009, its NCE-1 date is estimated to be 28 May, 2013.
Active Ingredient:
Besivance uses Besifloxacin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Besifloxacin Hydrochloride ingredient
Treatment:
Besivance is used for treating ocular bacterial infections.
Dosage:
Besivance is available in suspension/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.6% BASE | SUSPENSION/DROPS | Prescription | OPHTHALMIC |