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Last Updated: January 18, 2020

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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.

US ANDA Litigation and Generic Entry Outlook for Kovanaze

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Kovanaze was eligible for patent challenges on December 31st, 1968.

Summary for KOVANAZE
Drug patent expirations by year for KOVANAZE
Drug Prices for KOVANAZE

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Recent Clinical Trials for KOVANAZE

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

See all KOVANAZE clinical trials

Synonyms for KOVANAZE
Kovacaine
Kovacaine Mist
Kovacaine Nasal Spray
Kovanase
Oxymetazoline / tetracaine
Oxymetazoline hydrochloride / tetracaine hydrochloride
Oxymetazoline hydrochloride mixture with tetracaine hydrochloride
S900007440

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   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:

Baxter
Express Scripts
Mallinckrodt
Colorcon
AstraZeneca
Boehringer Ingelheim

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