Kovanaze is a drug owned by St Renatus Llc. It is protected by 3 US drug patents filed in 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 Apr 02, 2030. Details of Kovanaze'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). | |||
| US9308191 | Dental anesthetic comprising tetracaine and a vasoconstrictor for intranasal administration |
Apr, 2030
(5 years from now) | Active |
| US8580282 | Dental anesthetic comprising tetracaine and a vasoconstrictor for intranasal administration |
Apr, 2030
(5 years from now) | Active |
| US6413499 | Methods and kits for maxillary dental anesthesia by means of a nasal deliverable anesthetic |
Mar, 2020
(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 Kovanaze's patents.
Latest Legal Activities on Kovanaze's Patents
Given below is the list of recent legal activities going on the following patents of Kovanaze.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 20 May, 2024 | US9308191 |
| Maintenance Fee Reminder Mailed Critical | 04 Dec, 2023 | US9308191 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 28 Apr, 2021 | US8580282 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 27 Sep, 2019 | US9308191 |
| Email Notification Critical | 06 Apr, 2018 | US9308191 |
| Change in Power of Attorney (May Include Associate POA) Critical | 06 Apr, 2018 | US9308191 |
| Change in Power of Attorney (May Include Associate POA) Critical | 05 Apr, 2018 | US8580282 |
| Email Notification Critical | 05 Apr, 2018 | US8580282 |
| Correspondence Address Change Critical | 05 Apr, 2018 | US9308191 |
| Correspondence Address Change Critical | 04 Apr, 2018 | US8580282 |
FDA has granted several exclusivities to Kovanaze. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Kovanaze, 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 Kovanaze.
Exclusivity Information
Kovanaze holds 1 exclusivities. All of its exclusivities have expired in 2019. Details of Kovanaze's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Jun 29, 2019 |
US patents provide insights into the exclusivity only within the United States, but Kovanaze 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 Kovanaze's family patents as well as insights into ongoing legal events on those patents.
Kovanaze's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Kovanaze's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 02, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Kovanaze Generics:
There are no approved generic versions for Kovanaze as of now.
About Kovanaze
Kovanaze is a drug owned by St Renatus Llc. It is used for local anesthesia in the maxillary dental arch. Kovanaze uses Oxymetazoline Hydrochloride; Tetracaine Hydrochloride as an active ingredient. Kovanaze was launched by St Renatus in 2016.
Approval Date:
Kovanaze was approved by FDA for market use on 29 June, 2016.
Active Ingredient:
Kovanaze uses Oxymetazoline Hydrochloride; Tetracaine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Oxymetazoline Hydrochloride; Tetracaine Hydrochloride ingredient
Treatment:
Kovanaze is used for local anesthesia in the maxillary dental arch.
Dosage:
Kovanaze is available in spray, metered form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.1MG/SPRAY;6MG/SPRAY | SPRAY, METERED | Prescription | NASAL |