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KOVANAZE Drug Patent Profile

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
Drug Prices:	Drug price information for KOVANAZE
What excipients (inactive ingredients) are in KOVANAZE?	KOVANAZE excipients list
DailyMed Link:	KOVANAZE at DailyMed

See drug prices for KOVANAZE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for KOVANAZE

Constraining patent/regulatory exclusivity:

9,308,191

NDA:

208032

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

See all KOVANAZE clinical trials

US Patents and Regulatory Information for KOVANAZE

KOVANAZE is protected by two US patents.

This potential generic entry date is based on patent 9,308,191.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	9,308,191		Y
St Renatus	KOVANAZE	oxymetazoline hydrochloride; tetracaine hydrochloride	SPRAY, METERED;NASAL	208032-001	Jun 29, 2016		RX	Yes	Yes	8,580,282		Y

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	6,413,499

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

Brazil

Canada

China

Denmark

Eurasian Patent Organization

European Patent Office

Japan

Mexico

New Zealand

Poland

Portugal

South Africa

South Korea

Spain

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
Mexico	2011010445	ANESTESICO DENTAL QUE COMPRENDE TETRACAINA Y UN VASOCONSTRICTOR PARA ADMINISTRACION INTRANASAL. (DENTAL ANESTHETIC COMPRISING TETRACAINE AND A VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION.)
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)
Spain	2861064
Australia	2015242984	Dental Anesthetic Comprising Tetracaine and a Vasoconstrictor For Intranasal Administration
South Korea	20120042729	DENTAL ANESTHETIC COMPRISING TETRACAINE AND A VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION
South Korea	101747979
Japan	2015034167	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)

KOVANAZE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for KOVANAZE

Introduction

KOVANAZE, a nasal spray containing tetracaine HCl and oxymetazoline HCl, is indicated for regional anesthesia in dental procedures, particularly for teeth 4-13 and A-J in adults and children weighing 40 kg or more. This article delves into the market dynamics and financial trajectory of KOVANAZE, highlighting its clinical efficacy, market reception, and financial performance.

Clinical Efficacy and Approval

KOVANAZE was approved by the FDA in 2016 after demonstrating efficacy in several Phase 3 clinical trials. These trials showed that KOVANAZE could effectively provide regional anesthesia without the need for local anesthetic injections, especially in patients weighing 40 kg or more[2][3][4].

Market Need and Target Audience

The dental anesthesia market has a significant need for effective and convenient anesthetic solutions. KOVANAZE fills this gap by offering a non-invasive, easy-to-administer nasal spray that can anesthetize the targeted dental areas. The primary target audience includes dentists and oral surgeons performing restorative procedures, as well as patients seeking a more comfortable dental experience.

Adverse Reactions and Safety Profile

While KOVANAZE has shown a favorable risk-benefit profile, it is associated with several common adverse reactions, including rhinorrhea, nasal congestion, nasal discomfort, and oropharyngeal pain. Less common but notable adverse reactions include intranasal ulcerations and dysphagia[1][3][4].

Market Reception

The market reception of KOVANAZE has been positive, particularly among dental professionals seeking alternative anesthetic methods. The convenience and efficacy of the nasal spray have made it a viable option for many dental procedures. However, the presence of adverse reactions may influence prescribing decisions and patient compliance.

Financial Performance

The financial performance of KOVANAZE is closely tied to its market adoption and sales. Since its approval, KOVANAZE has generated significant revenue for its manufacturer, St. Renatus, LLC. Here are some key financial aspects:

Revenue Growth

KOVANAZE has contributed substantially to the revenue of St. Renatus, LLC, although exact figures are not publicly disclosed. The drug's approval and subsequent market entry have expanded the company's product portfolio and revenue streams.

Cost and Pricing

The pricing of KOVANAZE is a critical factor in its market dynamics. The cost of the nasal spray must balance between being competitive with other anesthetic options and reflecting its unique benefits and convenience. High pricing could limit adoption, while competitive pricing could enhance market penetration.

Financial Challenges

Despite the positive financial trajectory, St. Renatus, LLC has faced financial challenges. An investor lawsuit in 2016 highlighted concerns about the company's financial management and oversight, suggesting that the company had fallen into financial disarray[5].

Competitive Landscape

The dental anesthesia market is competitive, with various local anesthetic injections and other topical anesthetics available. KOVANAZE differentiates itself through its non-invasive nasal spray delivery method, which can be more appealing to patients and dentists alike. However, it must compete with established brands and other innovative products entering the market.

Regulatory Environment

The regulatory environment plays a crucial role in the financial trajectory of KOVANAZE. FDA approval was a significant milestone, but ongoing regulatory compliance and potential updates to labeling or usage guidelines can impact sales and revenue. Monitoring adverse reactions and ensuring patient safety are continuous regulatory requirements.

Market Expansion and Future Prospects

KOVANAZE has the potential for market expansion through increased adoption in dental practices and potential approvals for additional indications. The drug's efficacy in pediatric patients weighing 40 kg or more opens up a broader patient base. However, any expansion plans must be balanced with the need to address and mitigate adverse reactions.

Key Takeaways

• Clinical Efficacy: KOVANAZE has demonstrated efficacy in providing regional anesthesia for dental procedures.
• Market Reception: The drug has been well-received by dental professionals and patients due to its convenience and non-invasive delivery method.
• Adverse Reactions: Common and less common adverse reactions need to be managed to ensure patient safety.
• Financial Performance: KOVANAZE has contributed to the revenue of St. Renatus, LLC, but the company faces financial management challenges.
• Competitive Landscape: The drug competes in a competitive market but differentiates itself through its unique delivery method.
• Regulatory Environment: Ongoing regulatory compliance is crucial for maintaining market presence.

FAQs

1. What is KOVANAZE used for? KOVANAZE is used for regional anesthesia when performing restorative procedures on teeth 4-13 and A-J in adults and children who weigh 40 kg or more.

2. What are the common adverse reactions associated with KOVANAZE? Common adverse reactions include rhinorrhea, nasal congestion, nasal discomfort, and oropharyngeal pain.

3. How was KOVANAZE approved? KOVANAZE was approved by the FDA in 2016 after several Phase 3 clinical trials demonstrated its efficacy.

4. What are the financial challenges faced by St. Renatus, LLC? St. Renatus, LLC has faced financial management challenges and has been criticized for lack of oversight, leading to financial disarray.

5. What is the competitive advantage of KOVANAZE? KOVANAZE's non-invasive nasal spray delivery method differentiates it from other anesthetic options, making it more appealing to patients and dentists.

Sources

1. RxList - Kovanaze Drug Information
2. FDA - Clinical Review of Kovanaze NDA 208032
3. FDA - Kovanaze Nasal Spray Label
4. Drugs.com - Kovanaze Package Insert
5. Law360 - Anesthesia Firm Investor Says Board Has Entrenched Itself