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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Cantor Fitzgerald
Fish and Richardson
Deloitte
Express Scripts
Teva
US Army
Federal Trade Commission
Moodys

Generated: July 17, 2018

DrugPatentWatch Database Preview

KOVANAZE Drug Profile

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Which patents cover Kovanaze, and when can generic versions of Kovanaze launch?

Kovanaze is a drug marketed by St Renatus and is included in one NDA. There are three patents protecting this drug.

This drug has twenty-three patent family members in thirteen countries.

The generic ingredient in KOVANAZE is oxymetazoline hydrochloride; tetracaine hydrochloride. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the oxymetazoline hydrochloride; tetracaine hydrochloride profile page.
Summary for KOVANAZE
International Patents:23
US Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 1
Formulation / Manufacturing:see details
DailyMed Link:KOVANAZE at DailyMed
Drug patent expirations by year for KOVANAZE
Generic Entry Opportunity Date for KOVANAZE
Generic Entry Date for KOVANAZE*:
Constraining patent/regulatory exclusivity:
NEW COMBINATION
NDA:
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.

US Patents and Regulatory Information for 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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
St Renatus KOVANAZE oxymetazoline hydrochloride; tetracaine hydrochloride SPRAY, METERED;NASAL 208032-001 Jun 29, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
St Renatus KOVANAZE oxymetazoline hydrochloride; tetracaine hydrochloride SPRAY, METERED;NASAL 208032-001 Jun 29, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
St Renatus KOVANAZE oxymetazoline hydrochloride; tetracaine hydrochloride SPRAY, METERED;NASAL 208032-001 Jun 29, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for KOVANAZE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,855,247 Dental anesthetic comprising tetracaine and a vasoconstrictor for intranasal administration ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
US Department of Justice
Medtronic
Daiichi Sankyo
Dow
US Army
Covington
Farmers Insurance
Federal Trade Commission

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