DrugPatentWatch Database Preview
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.
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 KOVANAZE
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 1 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | KOVANAZE at DailyMed |
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 | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| St Renatus | KOVANAZE | oxymetazoline hydrochloride; tetracaine hydrochloride | SPRAY, METERED;NASAL | 208032-001 | Jun 29, 2016 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| St Renatus | KOVANAZE | oxymetazoline hydrochloride; tetracaine hydrochloride | SPRAY, METERED;NASAL | 208032-001 | Jun 29, 2016 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| St Renatus | KOVANAZE | oxymetazoline hydrochloride; tetracaine hydrochloride | SPRAY, METERED;NASAL | 208032-001 | Jun 29, 2016 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free 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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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 | ➤ Try a Free Trial |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for KOVANAZE
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 2012522783 | ➤ Try a Free Trial |
| Eurasian Patent Organization | 024184 | ➤ Try a Free Trial |
| European Patent Office | 2413899 | ➤ Try a Free Trial |
| Mexico | 2011010445 | ➤ Try a Free Trial |
| Japan | 2017031226 | ➤ Try a Free Trial |
| Japan | 2015034167 | ➤ Try a Free Trial |
| New Zealand | 595376 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
