Details for New Drug Application (NDA): 208032

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NDA 208032 describes KOVANAZE, which is a drug marketed by St Renatus and is included in one NDA. There are two patents protecting this drug. Additional details are available on the KOVANAZE profile page.

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.

Summary for 208032

Tradename:	KOVANAZE
Applicant:	St Renatus
Ingredient:	oxymetazoline hydrochloride; tetracaine hydrochloride
Patents:	2

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 208032

Generic Entry Date for 208032^: ⤷ Get Started Free* Constraining patent/regulatory exclusivity: ⤷ Get Started Free 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.

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY, METERED;NASAL			Strength	0.1MG/SPRAY;6MG/SPRAY
Approval Date:	Jun 29, 2016	TE:		RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Apr 2, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF ANESTHETIZING AT LEAST A PORTION OF THE MAXILLARY DENTAL ARCH
Patent:	⤷ Get Started Free	Patent Expiration:	Apr 2, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	METHOD OF ANESTHETIZING AT LEAST A PORTION OF THE MAXILLARY DENTAL ARCH

Expired US Patents for NDA 208032

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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	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Summary for 208032

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208032

Profile for product number 001

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 208032