Oxymetazoline hydrochloride; tetracaine hydrochloride - Generic Drug Details
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What are the generic drug sources for oxymetazoline hydrochloride; tetracaine hydrochloride and what is the scope of freedom to operate?
Oxymetazoline hydrochloride; tetracaine hydrochloride
is the generic ingredient in one branded drug marketed by St Renatus and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Oxymetazoline hydrochloride; tetracaine hydrochloride has twenty-six patent family members in sixteen countries.
Summary for oxymetazoline hydrochloride; tetracaine hydrochloride
| International Patents: | 26 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 8 |
| DailyMed Link: | oxymetazoline hydrochloride; tetracaine hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for oxymetazoline hydrochloride; tetracaine hydrochloride
*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.
Recent Clinical Trials for oxymetazoline hydrochloride; tetracaine hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of North Carolina, Chapel Hill | Phase 4 |
| Dow University of Health Sciences | Early Phase 1 |
| Louisiana State University Health Sciences Center in New Orleans | Phase 4 |
See all oxymetazoline hydrochloride; tetracaine hydrochloride clinical trials
Anatomical Therapeutic Chemical (ATC) Classes for oxymetazoline hydrochloride; tetracaine hydrochloride
US Patents and Regulatory Information for oxymetazoline hydrochloride; tetracaine hydrochloride
| 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 | 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 |
Expired US Patents for oxymetazoline hydrochloride; tetracaine hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| St Renatus | KOVANAZE | oxymetazoline hydrochloride; tetracaine hydrochloride | SPRAY, METERED;NASAL | 208032-001 | Jun 29, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for oxymetazoline hydrochloride; tetracaine hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 103932973 | Dental Anesthetic Comprising Tetracaine And A Vasoconstrictor For Intranasal Administration | ⤷ Sign Up |
| Poland | 2413899 | ⤷ Sign Up | |
| New Zealand | 612063 | Dental anesthetic comprising tetracaine and a vasoconstrictor for intranasal administration | ⤷ Sign Up |
| New Zealand | 595376 | DENTAL ANESTHETIC COMPRISING TETRACAINE AND A VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION | ⤷ Sign Up |
| Spain | 2861064 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
