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Last Updated: May 26, 2022

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-seven patent family members in seventeen 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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Summary for KOVANAZE
International Patents:27
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
Drug patent expirations by year for KOVANAZE
Drug Prices for KOVANAZE

See drug prices for KOVANAZE

DrugPatentWatch® Estimated Generic Entry Opportunity 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

SponsorPhase
Virginia Commonwealth UniversityPhase 2
University of North Carolina, Chapel HillPhase 4
Louisiana State University Health Sciences Center in New OrleansPhase 4

See all KOVANAZE clinical trials

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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
St Renatus KOVANAZE oxymetazoline hydrochloride; tetracaine hydrochloride SPRAY, METERED;NASAL 208032-001 Jun 29, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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: See Plans and Pricing

Patent: 15242984
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 1010303
Estimated Expiration: See Plans and Pricing

Canada

Patent: 57032
Estimated Expiration: See Plans and Pricing

China

Patent: 2421416
Estimated Expiration: See Plans and Pricing

Patent: 3932973
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 13899
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 4184
Estimated Expiration: See Plans and Pricing

Patent: 1171215
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 13899
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5489
Estimated Expiration: See Plans and Pricing

Japan

Patent: 88864
Estimated Expiration: See Plans and Pricing

Patent: 12522783
Estimated Expiration: See Plans and Pricing

Patent: 15034167
Estimated Expiration: See Plans and Pricing

Patent: 17031226
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 11010445
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 5376
Estimated Expiration: See Plans and Pricing

Patent: 2063
Estimated Expiration: See Plans and Pricing

Poland

Patent: 13899
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 13899
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1107011
Estimated Expiration: See Plans and Pricing

Patent: 1309321
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1747979
Estimated Expiration: See Plans and Pricing

Patent: 120042729
Estimated Expiration: See Plans and Pricing

Patent: 170026639
Estimated Expiration: See Plans and Pricing

Spain

Patent: 61064
Estimated Expiration: See Plans and Pricing

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
New Zealand 595376 DENTAL ANESTHETIC COMPRISING TETRACAINE AND A VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION See Plans and Pricing
Israel 215489 See Plans and Pricing
Mexico 2011010445 ANESTESICO DENTAL QUE COMPRENDE TETRACAINA Y UN VASOCONSTRICTOR PARA ADMINISTRACION INTRANASAL. (DENTAL ANESTHETIC COMPRISING TETRACAINE AND A VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION.) See Plans and Pricing
Australia 2015242984 Dental Anesthetic Comprising Tetracaine and a Vasoconstrictor For Intranasal Administration See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
AstraZeneca
Baxter
Express Scripts
McKesson
Boehringer Ingelheim

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.