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^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 9,308,191 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:	8,580,282	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:	9,308,191	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	6,413,499	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent 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.

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