Bromsite is a drug owned by Sun Pharmaceutical Industries Ltd. It is protected by 2 US drug patents filed from 2016 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 07, 2029. Details of Bromsite'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). | |||
| US8778999 | Non-steroidal anti-inflammatory ophthalmic compositions |
Aug, 2029
(4 years from now) | Active |
| USRE50218 | Non-steroidal anti-inflammatory ophthalmic compositions |
Mar, 2029
(3 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 Bromsite's patents.
Latest Legal Activities on Bromsite's Patents
Given below is the list of recent legal activities going on the following patents of Bromsite.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Jan, 2022 | US8778999 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 19 Dec, 2017 | US8778999 |
| Patent Issue Date Used in PTA Calculation Critical | 15 Jul, 2014 | US8778999 |
| Recordation of Patent Grant Mailed Critical | 15 Jul, 2014 | US8778999 |
| Email Notification Critical | 26 Jun, 2014 | US8778999 |
| Issue Notification Mailed Critical | 25 Jun, 2014 | US8778999 |
| Dispatch to FDC | 10 Jun, 2014 | US8778999 |
| Application Is Considered Ready for Issue Critical | 10 Jun, 2014 | US8778999 |
| Electronic Review Critical | 03 Jun, 2014 | US8778999 |
| Email Notification Critical | 03 Jun, 2014 | US8778999 |
FDA has granted several exclusivities to Bromsite. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Bromsite, 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 Bromsite.
Exclusivity Information
Bromsite holds 1 exclusivities. All of its exclusivities have expired in 2019. Details of Bromsite's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Apr 08, 2019 |
US patents provide insights into the exclusivity only within the United States, but Bromsite 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 Bromsite's family patents as well as insights into ongoing legal events on those patents.
Bromsite's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Bromsite's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 07, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Bromsite Generic API suppliers:
Bromfenac Sodium is the generic name for the brand Bromsite. 11 different companies have already filed for the generic of Bromsite, with Lupin Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Bromsite's generic
How can I launch a generic of Bromsite before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Bromsite's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Bromsite'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 Bromsite -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.00075 | 25 Oct, 2017 | 1 | 07 Aug, 2029 |
Alternative Brands for Bromsite
Bromsite which is used for managing postoperative inflammation and preventing ocular pain in patients undergoing cataract surgery., has several other brand drugs using the same active ingredient (Bromfenac Sodium). 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 | |
|---|---|---|
| Bausch And Lomb |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Bromfenac Sodium, Bromsite's active ingredient. Check the complete list of approved generic manufacturers for Bromsite
About Bromsite
Bromsite is a drug owned by Sun Pharmaceutical Industries Ltd. It is used for managing postoperative inflammation and preventing ocular pain in patients undergoing cataract surgery. Bromsite uses Bromfenac Sodium as an active ingredient. Bromsite was launched by Sun Pharm in 2016.
Can you believe Bromsite received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Bromsite was approved by FDA for market use on 08 April, 2016.
Active Ingredient:
Bromsite uses Bromfenac Sodium as the active ingredient. Check out other Drugs and Companies using Bromfenac Sodium ingredient
Treatment:
Bromsite is used for managing postoperative inflammation and preventing ocular pain in patients undergoing cataract surgery.
Dosage:
Bromsite is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.075% ACID | SOLUTION/DROPS | Prescription | OPHTHALMIC |