Simbrinza is a drug owned by Alcon Laboratories Inc. It is protected by 3 US drug patents filed from 2013 to 2016. Out of these, 2 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 30, 2030. Details of Simbrinza'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). | |||
| US9044484 | Aqueous pharmaceutical compositions containing borate-polyol complexes |
Oct, 2030
(5 years from now) | Active |
| US9421265 | Aqueous pharmaceutical compositions containing borate-polyol complexes |
Jun, 2030
(5 years from now) | Active |
| US6316441 | Brinzolamide and brimonidine for treating glaucoma |
Dec, 2019
(4 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 Simbrinza's patents.
Latest Legal Activities on Simbrinza's Patents
Given below is the list of recent legal activities going on the following patents of Simbrinza.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Feb, 2024 | US9421265 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Nov, 2022 | US9044484 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 06 Feb, 2020 | US9421265 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Nov, 2018 | US9044484 |
| Recordation of Patent Grant Mailed Critical | 23 Aug, 2016 | US9421265 |
| Patent Issue Date Used in PTA Calculation Critical | 23 Aug, 2016 | US9421265 |
| Email Notification Critical | 04 Aug, 2016 | US9421265 |
| Issue Notification Mailed Critical | 03 Aug, 2016 | US9421265 |
| Email Notification Critical | 01 Aug, 2016 | US9421265 |
| Mail Interview Summary - Examiner Initiated - Telephonic | 01 Aug, 2016 | US9421265 |
FDA has granted several exclusivities to Simbrinza. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Simbrinza, 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 Simbrinza.
Exclusivity Information
Simbrinza holds 1 exclusivities. All of its exclusivities have expired in 2016. Details of Simbrinza's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Apr 19, 2016 |
Several oppositions have been filed on Simbrinza'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 Simbrinza's generic, the next section provides detailed information on ongoing and past EP oppositions related to Simbrinza patents.
Simbrinza's Oppositions Filed in EPO
Simbrinza has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 22, 2014, by Teva Pharmaceutical Industries Ltd.. This opposition was filed on patent number EP10727317A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP16159225A | Jan, 2021 | Generics [UK] Limited | Granted and Under Opposition |
| EP14150805A | Jan, 2017 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP14150805A | Jan, 2017 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP10727317A | Jan, 2015 | Generics [UK] Ltd (trading as Mylan) | Revoked |
| EP10727317A | Dec, 2014 | Teva Pharmaceutical Industries LTD. | Revoked |
US patents provide insights into the exclusivity only within the United States, but Simbrinza 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 Simbrinza's family patents as well as insights into ongoing legal events on those patents.
Simbrinza's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Simbrinza's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 30, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Simbrinza Generics:
There are no approved generic versions for Simbrinza as of now.
How can I launch a generic of Simbrinza before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Simbrinza's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Simbrinza'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 Simbrinza -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1%/0.2% | 01 Aug, 2022 | 1 | 30 Oct, 2030 |
Alternative Brands for Simbrinza
Simbrinza which is used for reducing elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension., 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 | ||
|---|---|---|---|---|
| Thea Pharma |
| |||
About Simbrinza
Simbrinza is a drug owned by Alcon Laboratories Inc. It is used for reducing elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Simbrinza uses Brimonidine Tartrate; Brinzolamide as an active ingredient. Simbrinza was launched by Alcon Labs Inc in 2013.
Approval Date:
Simbrinza was approved by FDA for market use on 19 April, 2013.
Active Ingredient:
Simbrinza uses Brimonidine Tartrate; Brinzolamide as the active ingredient. Check out other Drugs and Companies using Brimonidine Tartrate; Brinzolamide ingredient
Treatment:
Simbrinza is used for reducing elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
Dosage:
Simbrinza is available in suspension/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.2%;1% | SUSPENSION/DROPS | Prescription | OPHTHALMIC |