Vyzulta is a drug owned by Bausch And Lomb Inc. It is protected by 5 US drug patents filed in 2018. Out of these, 4 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 21, 2029. Details of Vyzulta's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US6211233 | Prostaglandin pharmaceutical compositions |
Jun, 2018
(6 years ago) |
Expired
|
| US7910767 | Prostaglandin derivatives |
Jan, 2025
(5 months from now) | Active |
| US7273946 | Prostaglandin derivatives |
Oct, 2025
(1 year, 2 months from now) | Active |
| US8058467 | Prostaglandin derivatives |
Feb, 2029
(4 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7629345 | Prostaglandin derivatives |
Jan, 2025
(5 months 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 Vyzulta's patents.
Latest Legal Activities on Vyzulta's Patents
Given below is the list of recent legal activities going on the following patents of Vyzulta.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Patent Term Extension Certificate | 18 Mar, 2024 | US8058467 |
| Withdrawal of Application for PTE | 18 Mar, 2024 | US7273946 |
| Withdrawal of Application for PTE | 18 Mar, 2024 | US7629345 |
| Notice of Final Determination -Election Required | 13 Feb, 2024 | US7273946 |
| Notice of Final Determination -Election Required | 13 Feb, 2024 | US7629345 |
| Notice of Final Determination -Election Required | 13 Feb, 2024 | US8058467 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 02 Feb, 2024 | US7629345 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 02 Feb, 2024 | US7273946 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 02 Feb, 2024 | US8058467 |
| Requirement for information sent under 37 CFR 1.750 | 26 Jan, 2024 | US8058467 |
Several oppositions have been filed on Vyzulta'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 Vyzulta's generic, the next section provides detailed information on ongoing and past EP oppositions related to Vyzulta patents.
Vyzulta's oppositions filed in EPO
Vyzulta has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Nov 23, 2016, by Teva Pharmaceutical Industries Ltd. This opposition was filed on patent number EP04804405A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP04804405A | Nov, 2016 | Teva Pharmaceutical Industries Ltd | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Vyzulta 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 Vyzulta's family patents as well as insights into ongoing legal events on those patents.
Vyzulta's family patents
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Generic Launch
Generic Release Date:
Vyzulta's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 21, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vyzulta Generics:
There are no approved generic versions for Vyzulta as of now.
How can I launch a generic of Vyzulta before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Vyzulta's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Vyzulta'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 Vyzulta -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.00024 | 31 Mar, 2022 | 1 | 03 Oct, 2025 |
About Vyzulta
Vyzulta is a drug owned by Bausch And Lomb Inc. It is used for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Vyzulta uses Latanoprostene Bunod as an active ingredient. Vyzulta was launched by Bausch And Lomb in 2017.
Market Authorisation Date:
Vyzulta was approved by FDA for market use on 02 November, 2017.
Active Ingredient:
Vyzulta uses Latanoprostene Bunod as the active ingredient. Check out other Drugs and Companies using Latanoprostene Bunod ingredient
Treatment:
Vyzulta is used for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Dosage:
Vyzulta is available in solution/drops form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.024% | SOLUTION/DROPS | Prescription | OPHTHALMIC |