Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Teva
Deloitte
Federal Trade Commission
Harvard Business School
AstraZeneca
US Department of Justice
Daiichi Sankyo
McKinsey

Generated: October 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208032

« Back to Dashboard

NDA 208032 describes KOVANAZE, which is a drug marketed by St Renatus and is included in one NDA. There are three 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
Generic Entry Opportunity Date for 208032
Generic Entry Date for 208032*:
Constraining patent/regulatory exclusivity:
NEW COMBINATION
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:RXDosage:SPRAY, METERED;NASALStrength0.1MG/SPRAY;6MG/SPRAY
Approval Date:Jun 29, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 29, 2019
Regulatory Exclusivity Use:NEW COMBINATION
Patent:➤ Sign UpPatent Expiration:Mar 20, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF ANESTHETIZING AT LEAST A PORTION OF THE MAXILLARY DENTAL ARCH
Patent:➤ Sign UpPatent Expiration:Apr 2, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF ANESTHETIZING AT LEAST A PORTION OF THE MAXILLARY DENTAL ARCH

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Covington
US Department of Justice
UBS
US Army
McKinsey
Colorcon
Johnson and Johnson
Mallinckrodt
Cipla

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 verifification 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.