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
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Questions you can ask:
- What is the 5 year forecast for KOVANAZE?
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Summary for KOVANAZE
| International Patents: | 26 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 5 |
| 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
*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 |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| St Renatus | KOVANAZE | oxymetazoline hydrochloride; tetracaine hydrochloride | SPRAY, METERED;NASAL | 208032-001 | Jun 29, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| >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
Patent: Dental anesthetic comprising tetracaine and a vasoconstrictor for intranasal administration
Estimated Expiration: ⤷ Sign Up
Patent: 15242984
Patent: Dental Anesthetic Comprising Tetracaine and a Vasoconstrictor For Intranasal Administration
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 1010303
Patent: anestésico dental compreendendo tetracaína e um vasoconstritor para administração intranasal.
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 57032
Patent: ANESTHESIQUE DENTAIRE COMPRENANT DE LA TETRACAINE ET UN VASOCONSTRICTEUR POUR ADMINISTRATION INTRANASALE (DENTAL ANESTHETIC COMPRISING TETRACAINE AND A VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION)
Estimated Expiration: ⤷ Sign Up
China
Patent: 2421416
Patent: Dental anesthetic comprising tetracaine and a vasoconstrictor for intranasal administration
Estimated Expiration: ⤷ Sign Up
Patent: 3932973
Patent: Dental Anesthetic Comprising Tetracaine And A Vasoconstrictor For Intranasal Administration
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 13899
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 4184
Patent: СТОМАТОЛОГИЧЕСКОЕ АНЕСТЕЗИРУЮЩЕЕ СРЕДСТВО ДЛЯ ИНТРАНАЗАЛЬНОГО ВВЕДЕНИЯ, СОДЕРЖАЩЕЕ ТЕТРАКАИН И ВАЗОКОНСТРИКТОР (DENTAL ANESTHETIC COMPRISING TETRACAINE AND A VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION)
Estimated Expiration: ⤷ Sign Up
Patent: 1171215
Patent: СТОМАТОЛОГИЧЕСКОЕ АНЕСТЕЗИРУЮЩЕЕ СРЕДСТВО ДЛЯ ИНТРАНАЗАЛЬНОГО ВВЕДЕНИЯ, СОДЕРЖАЩЕЕ ТЕТРАКАИН И ВАЗОКОНСТРИКТОР
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 13899
Patent: ANESTHÉSIQUE DENTAIRE COMPRENANT DE LA TÉTRACAÏNE ET UN VASOCONSTRICTEUR POUR ADMINISTRATION INTRANASALE (DENTAL ANESTHETIC COMPRISING TETRACAINE AND A VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 88864
Estimated Expiration: ⤷ Sign Up
Patent: 12522783
Estimated Expiration: ⤷ Sign Up
Patent: 15034167
Patent: 鼻腔内投与用のテトラカインおよび血管収縮薬を含む歯科用麻酔剤 (DENTAL ANESTHETIC COMPRISING TETRACAINE AND VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION)
Estimated Expiration: ⤷ Sign Up
Patent: 17031226
Patent: 鼻腔内投与用のテトラカインおよび血管収縮薬を含む歯科用麻酔剤 (DENTAL ANESTHETIC COMPRISING TETRACAINE AND VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION)
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 11010445
Patent: ANESTESICO DENTAL QUE COMPRENDE TETRACAINA Y UN VASOCONSTRICTOR PARA ADMINISTRACION INTRANASAL. (DENTAL ANESTHETIC COMPRISING TETRACAINE AND A VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 5376
Patent: DENTAL ANESTHETIC COMPRISING TETRACAINE AND A VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION
Estimated Expiration: ⤷ Sign Up
Patent: 2063
Patent: Dental anesthetic comprising tetracaine and a vasoconstrictor for intranasal administration
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 13899
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 13899
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1107011
Patent: DENTAL ANESTHETIC COMPRISING TETRACAINE AND A VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION
Estimated Expiration: ⤷ Sign Up
Patent: 1309321
Patent: DENTAL ANESTHETIC COMPRISING TETRACAINE AND A VASOCONSTRICTOR FPR INTRANASAL ADMINISTRATION
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1747979
Estimated Expiration: ⤷ Sign Up
Patent: 120042729
Patent: DENTAL ANESTHETIC COMPRISING TETRACAINE AND A VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION
Estimated Expiration: ⤷ Sign Up
Patent: 170026639
Patent: 비강 투여를 위한 테트라카인 및 혈관수축제를 포함하는 치과용 마취제 (DENTAL ANESTHETIC COMPRISING TETRACAINE AND A VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 61064
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Brazil | PI1010303 | anestésico dental compreendendo tetracaína e um vasoconstritor para administração intranasal. | ⤷ Sign Up |
| Mexico | 2011010445 | ANESTESICO DENTAL QUE COMPRENDE TETRACAINA Y UN VASOCONSTRICTOR PARA ADMINISTRACION INTRANASAL. (DENTAL ANESTHETIC COMPRISING TETRACAINE AND A VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION.) | ⤷ Sign Up |
| South Korea | 20120042729 | DENTAL ANESTHETIC COMPRISING TETRACAINE AND A VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION | ⤷ Sign Up |
| European Patent Office | 2413899 | ANESTHÉSIQUE DENTAIRE COMPRENANT DE LA TÉTRACAÏNE ET UN VASOCONSTRICTEUR POUR ADMINISTRATION INTRANASALE (DENTAL ANESTHETIC COMPRISING TETRACAINE AND A VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION) | ⤷ Sign Up |
| Japan | 2017031226 | 鼻腔内投与用のテトラカインおよび血管収縮薬を含む歯科用麻酔剤 (DENTAL ANESTHETIC COMPRISING TETRACAINE AND VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION) | ⤷ Sign Up |
| Japan | 5788864 | ⤷ Sign Up | |
| Japan | 2012522783 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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