KOVANAZE Drug Patent Profile
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When do Kovanaze patents expire, and what generic alternatives are available?
Kovanaze is a drug marketed by St Renatus and is included in one NDA. There are two patents protecting this drug.
This drug has twenty-six patent family members in sixteen countries.
The generic ingredient in KOVANAZE is oxymetazoline hydrochloride; tetracaine hydrochloride. There are three drug master file entries for this compound. Additional details are available on the oxymetazoline hydrochloride; tetracaine hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Kovanaze
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be April 2, 2030. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for KOVANAZE
International Patents: | 26 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 5 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for KOVANAZE |
What excipients (inactive ingredients) are in KOVANAZE? | KOVANAZE excipients list |
DailyMed Link: | KOVANAZE at DailyMed |


DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for KOVANAZE
Generic Entry Date for KOVANAZE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SPRAY, METERED;NASAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for KOVANAZE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Virginia Commonwealth University | Phase 2 |
University of North Carolina, Chapel Hill | Phase 4 |
Louisiana State University Health Sciences Center in New Orleans | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for KOVANAZE
US Patents and Regulatory Information for KOVANAZE
KOVANAZE is protected by two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of KOVANAZE is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting KOVANAZE
Dental anesthetic comprising tetracaine and a vasoconstrictor for intranasal administration
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF ANESTHETIZING AT LEAST A PORTION OF THE MAXILLARY DENTAL ARCH
Dental anesthetic comprising tetracaine and a vasoconstrictor for intranasal administration
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF ANESTHETIZING AT LEAST A PORTION OF THE MAXILLARY DENTAL ARCH
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
St Renatus | KOVANAZE | oxymetazoline hydrochloride; tetracaine hydrochloride | SPRAY, METERED;NASAL | 208032-001 | Jun 29, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
St Renatus | KOVANAZE | oxymetazoline hydrochloride; tetracaine hydrochloride | SPRAY, METERED;NASAL | 208032-001 | Jun 29, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for KOVANAZE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
St Renatus | KOVANAZE | oxymetazoline hydrochloride; tetracaine hydrochloride | SPRAY, METERED;NASAL | 208032-001 | Jun 29, 2016 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for KOVANAZE
When does loss-of-exclusivity occur for KOVANAZE?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 10232995
Estimated Expiration: ⤷ Try a Trial
Patent: 15242984
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 1010303
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 57032
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2421416
Estimated Expiration: ⤷ Try a Trial
Patent: 3932973
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 13899
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 4184
Estimated Expiration: ⤷ Try a Trial
Patent: 1171215
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 13899
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 88864
Estimated Expiration: ⤷ Try a Trial
Patent: 12522783
Estimated Expiration: ⤷ Try a Trial
Patent: 15034167
Estimated Expiration: ⤷ Try a Trial
Patent: 17031226
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 11010445
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 5376
Estimated Expiration: ⤷ Try a Trial
Patent: 2063
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 13899
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 13899
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1107011
Estimated Expiration: ⤷ Try a Trial
Patent: 1309321
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1747979
Estimated Expiration: ⤷ Try a Trial
Patent: 120042729
Estimated Expiration: ⤷ Try a Trial
Patent: 170026639
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 61064
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering KOVANAZE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Eurasian Patent Organization | 201171215 | СТОМАТОЛОГИЧЕСКОЕ АНЕСТЕЗИРУЮЩЕЕ СРЕДСТВО ДЛЯ ИНТРАНАЗАЛЬНОГО ВВЕДЕНИЯ, СОДЕРЖАЩЕЕ ТЕТРАКАИН И ВАЗОКОНСТРИКТОР | ⤷ Try a Trial |
Denmark | 2413899 | ⤷ Try a Trial | |
South Africa | 201107011 | DENTAL ANESTHETIC COMPRISING TETRACAINE AND A VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION | ⤷ Try a Trial |
Japan | 5788864 | ⤷ Try a Trial | |
South Korea | 101747979 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |