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Last Updated: March 4, 2021

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KOVANAZE Drug Profile

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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 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. Additional details are available on the oxymetazoline hydrochloride; tetracaine hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Kovanaze

Indicators of Generic Entry

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Summary for KOVANAZE
International Patents:23
US Patents:3
Applicants:1
NDAs:1
Bulk Api Vendors: 1
Clinical Trials: 4
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
Drug patent expirations by year for KOVANAZE
Drug Prices for KOVANAZE

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Recent Clinical Trials for KOVANAZE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Virginia Commonwealth UniversityPhase 2
University of North Carolina, Chapel HillPhase 4

See all KOVANAZE clinical trials

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   Start Trial   Start Trial Y   Start Trial
St Renatus KOVANAZE oxymetazoline hydrochloride; tetracaine hydrochloride SPRAY, METERED;NASAL 208032-001 Jun 29, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
St Renatus KOVANAZE oxymetazoline hydrochloride; tetracaine hydrochloride SPRAY, METERED;NASAL 208032-001 Jun 29, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
AstraZeneca
Baxter
Express Scripts
McKesson
Boehringer Ingelheim

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