Vyzulta Patent Expiration

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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US8058467 Prostaglandin derivatives
Feb, 2029

(4 years from now)

Active
US7273946 Prostaglandin derivatives
Oct, 2025

(9 months from now)

Active
US7910767 Prostaglandin derivatives
Jan, 2025

(16 days from now)

Active
US6211233 Prostaglandin pharmaceutical compositions
Jun, 2018

(6 years ago)

Expired
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7629345 Prostaglandin derivatives
Jan, 2025

(16 days 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.

Given below is the list of recent legal activities going on the following patents of Vyzulta.

Activity Date Patent Number
Patent litigations
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

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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
Patent litigations
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

Vyzulta has patent protection in a total of 38 countries. It's US patent count contributes only to 9.8% of its total global patent coverage. 8 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Vyzulta.

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.

Approval 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