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-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

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

See drug prices for KOVANAZE

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for KOVANAZE

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

Anatomical Therapeutic Chemical (ATC) Classes for KOVANAZE

C05AD	Local anesthetics
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D04AB	Anesthetics for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

N01BA	Esters of aminobenzoic acid
N01B	ANESTHETICS, LOCAL
N01	ANESTHETICS
N	Nervous system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

S01GA	Sympathomimetics used as decongestants
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01HA	Local anesthetics
S01H	LOCAL ANESTHETICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for KOVANAZE

KOVANAZE is protected by two US patents.

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

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			Y
St Renatus	KOVANAZE	oxymetazoline hydrochloride; tetracaine hydrochloride	SPRAY, METERED;NASAL	208032-001	Jun 29, 2016		RX	Yes	Yes			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

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

Israel

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