Prolensa is a drug owned by Bausch And Lomb Inc. It is protected by 9 US drug patents filed from 2013 to 2018. Out of these, 3 drug patents are active and 6 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 11, 2033. Details of Prolensa'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. | |||
| US8129431 | Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid |
Sep, 2025
(9 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9517220 | Bromfenac bioavailability |
Nov, 2033
(8 years from now) | Active |
| US10085958 | Bromfenac bioavailability |
Nov, 2032
(8 years from now) | Active |
| US8871813 | Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid |
Jan, 2024
(9 months ago) |
Expired
|
| US9144609 | Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid |
Jan, 2024
(9 months ago) |
Expired
|
| US9561277 | Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid |
Jan, 2024
(9 months ago) |
Expired
|
| US8669290 | Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid |
Jan, 2024
(9 months ago) |
Expired
|
| US8927606 | Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid |
Jan, 2024
(9 months ago) |
Expired
|
| US8754131 | Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid |
Jan, 2024
(9 months 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 Prolensa's patents.
Latest Legal Activities on Prolensa's Patents
Given below is the list of recent legal activities going on the following patents of Prolensa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 May, 2024 | US9517220 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Mar, 2023 | US9144609 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Jun, 2022 | US8927606 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 Mar, 2022 | US10085958 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 14 Mar, 2022 | US8871813 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Dec, 2021 | US8754131 (Litigated) |
| Correspondence Address Change Critical | 30 Aug, 2021 | US10085958 |
| Correspondence Address Change Critical | 30 Aug, 2021 | US9517220 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Aug, 2021 | US8669290 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 04 Jun, 2020 | US9517220 |
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 Prolensa and ongoing litigations to help you estimate the early arrival of Prolensa generic.
Prolensa's Litigations
Prolensa been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 26, 2014, against patent number US8669290. The petitioner Metrics, 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 Prolensa's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8669290 | April, 2015 |
FWD Entered
(12 Sep, 2016) | SENJU PHARMACEUTICAL CO., LTD. | Lupin Ltd. |
| US8754131 | April, 2015 |
FWD Entered
(12 Sep, 2016) | SENJU PHARMACEUTICAL CO., LTD. | Lupin Ltd. |
| US8754131 | November, 2015 |
FWD Entered
(12 Sep, 2016) | SENJU PHARMACEUTICAL CO., LTD. | InnoPharma Licensing, Inc. |
| US8871813 | April, 2015 |
FWD Entered
(12 Sep, 2016) | SENJU PHARMACEUTICAL CO., LTD. | Lupin Ltd. |
| US8871813 | November, 2015 |
FWD Entered
(12 Sep, 2016) | SENJU PHARMACEUTICAL CO., LTD. | InnoPharma Licensing, Inc. |
| US8927606 | April, 2015 |
FWD Entered
(12 Sep, 2016) | Senju Pharmaceutical Co., Ltd. | Lupin Ltd. |
| US8927606 | November, 2015 |
FWD Entered
(12 Sep, 2016) | SENJU PHARMACEUTICAL CO., LTD. | InnoPharma Licensing, Inc. |
| US8129431 | September, 2015 |
FWD Entered
(05 Aug, 2016) | SENJU PHARMACEUTICAL CO., LTD. | Lupin Ltd. |
| US8129431 | March, 2015 |
FWD Entered
(28 Jul, 2016) | Senju Pharmaceutical Co., Ltd. | InnoPharma, Licensing, Inc. |
| US8669290 | March, 2015 |
FWD Entered
(28 Jul, 2016) | SENJU PHARMACEUTICAL CO., LTD. | InnoPharma Licensing, Inc. |
| US8129431 | June, 2014 |
Terminated-Settled
(08 Jul, 2015) | Senju Pharmaceutical Co., Ltd. | Metrics, Inc. c/o Duane Morris LLP |
| US8669290 | June, 2014 |
Terminated-Settled
(08 Jul, 2015) | SENJU PHARMACEUTICAL CO., LTD. | Metrics, Inc. |
FDA has granted some exclusivities to Prolensa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Prolensa, 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 Prolensa.
Exclusivity Information
Prolensa holds 1 exclusivities. All of its exclusivities have expired in 2016. Details of Prolensa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Apr 05, 2016 |
Several oppositions have been filed on Prolensa's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Prolensa's generic, the next section provides detailed information on ongoing and past EP oppositions related to Prolensa patents.
Prolensa's Oppositions Filed in EPO
Prolensa has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 30, 2009, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP04702854A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP04702854A | Jan, 2009 | Teva Pharmaceutical Industries Ltd. | Opposition procedure closed |
US patents provide insights into the exclusivity only within the United States, but Prolensa 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 Prolensa's family patents as well as insights into ongoing legal events on those patents.
Prolensa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Prolensa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 11, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Prolensa Generic API suppliers:
Bromfenac Sodium is the generic name for the brand Prolensa. 11 different companies have already filed for the generic of Prolensa, with Lupin Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Prolensa's generic
How can I launch a generic of Prolensa before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Prolensa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Prolensa'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 Prolensa -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0007 | 26 Jul, 2013 | 1 | 11 Sep, 2025 | Non-Forfeiture |
Alternative Brands for Prolensa
Prolensa which is used for managing ocular inflammation, postoperative inflammation, and reducing ocular pain in patients after cataract surgery., has several other brand drugs in the same treatment category and 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 | Treatment Area | ||
|---|---|---|---|---|
| Harrow Eye |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Bromfenac Sodium. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Sun Pharm |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Bromfenac Sodium, Prolensa's active ingredient. Check the complete list of approved generic manufacturers for Prolensa
About Prolensa
Prolensa is a drug owned by Bausch And Lomb Inc. It is used for managing ocular inflammation, postoperative inflammation, and reducing ocular pain in patients after cataract surgery. Prolensa uses Bromfenac Sodium as an active ingredient. Prolensa was launched by Bausch And Lomb in 2013.
Approval Date:
Prolensa was approved by FDA for market use on 05 April, 2013.
Active Ingredient:
Prolensa uses Bromfenac Sodium as the active ingredient. Check out other Drugs and Companies using Bromfenac Sodium ingredient
Treatment:
Prolensa is used for managing ocular inflammation, postoperative inflammation, and reducing ocular pain in patients after cataract surgery.
Dosage:
Prolensa is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.07% ACID | SOLUTION/DROPS | Prescription | OPHTHALMIC |