Verkazia is a drug owned by Harrow Eye Llc. It is protected by 7 US drug patents filed from 2021 to 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 02, 2029. Details of Verkazia'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9956289 | Emulsion compositions containing quaternary ammonium compounds |
Jan, 2026
(1 year, 6 months from now) | Active |
| US11612658 | Oil-in-water emulsions comprising cetalkonium chloride and methods of making and using the same |
Jan, 2026
(1 year, 6 months from now) | Active |
| US8524779 | Emulsion compositions containing quaternary ammonium compounds |
Jan, 2026
(1 year, 6 months from now) | Active |
| US9220694 | Emulsion compositions containing cetalkonium chloride |
Jan, 2026
(1 year, 6 months from now) | Active |
| US7973081 | Emulsion compositions containing quaternary ammonium compounds |
Jan, 2026
(1 year, 6 months from now) | Active |
| US8298568 | Oil-in-water type emulsion with low concentration of cationic agent and positive zeta potential |
Nov, 2027
(3 years from now) | Active |
| US9132071 | Compositions containing quaternary ammonium compounds |
Jun, 2029
(4 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 Verkazia's patents.
Latest Legal Activities on Verkazia's Patents
Given below is the list of recent legal activities going on the following patents of Verkazia.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 23 Apr, 2024 | US8298568 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Jun, 2023 | US9220694 |
| Recordation of Patent Grant Mailed | 28 Mar, 2023 | US11612658 |
| Patent Issue Date Used in PTA Calculation | 28 Mar, 2023 | US11612658 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Mar, 2023 | US9132071 |
| Email Notification | 09 Mar, 2023 | US11612658 |
| Issue Notification Mailed | 08 Mar, 2023 | US11612658 |
| Application Is Considered Ready for Issue | 15 Feb, 2023 | US11612658 |
| Dispatch to FDC | 15 Feb, 2023 | US11612658 |
| Issue Fee Payment Verified | 14 Feb, 2023 | US11612658 |
FDA has granted several exclusivities to Verkazia. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Verkazia, 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 Verkazia.
Exclusivity Information
Verkazia holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Verkazia's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jun 23, 2024 |
| Orphan Drug Exclusivity(ODE-358) | Jun 23, 2028 |
US patents provide insights into the exclusivity only within the United States, but Verkazia 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 Verkazia's family patents as well as insights into ongoing legal events on those patents.
Verkazia's family patents
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Generic Launch
Generic Release Date:
Verkazia's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 02, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Verkazia Generics:
Cyclosporine is the generic name for the brand Verkazia. 14 different companies have already filed for the generic of Verkazia, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Verkazia's generic
About Verkazia
Verkazia is a drug owned by Harrow Eye Llc. It is used for treating vernal keratoconjunctivitis in children and adults. Verkazia uses Cyclosporine as an active ingredient. Verkazia was launched by Harrow Eye in 2021.
Can you believe Verkazia 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.
Market Authorisation Date:
Verkazia was approved by FDA for market use on 23 June, 2021.
Active Ingredient:
Verkazia uses Cyclosporine as the active ingredient. Check out other Drugs and Companies using Cyclosporine ingredient
Treatment:
Verkazia is used for treating vernal keratoconjunctivitis in children and adults.
Dosage:
Verkazia is available in emulsion form for ophthalmic use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.1% | EMULSION | Prescription | OPHTHALMIC |