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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
Kovanaze was eligible for patent challenges on December 31st, 1968.
Summary for KOVANAZE
| International Patents: | 23 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 4 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for KOVANAZE |
| DailyMed Link: | KOVANAZE at DailyMed |
Recent Clinical Trials for KOVANAZE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Virginia Commonwealth University | Phase 2 |
| University of North Carolina, Chapel Hill | Phase 4 |
Pharmacology for KOVANAZE
| Drug Class | Ester Local Anesthetic Vasoconstrictor |
| Physiological Effect | Local Anesthesia Vasoconstriction Increased Sympathetic Activity |
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 |
International Patents for KOVANAZE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Africa | 201107011 | Start Trial |
| New Zealand | 595376 | Start Trial |
| New Zealand | 612063 | Start Trial |
| Eurasian Patent Organization | 201171215 | Start Trial |
| Japan | 5788864 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
