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Last Updated: March 28, 2024

OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE - Generic Drug Details


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What are the generic 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
Generic Entry Date for OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
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.

Recent Clinical Trials for OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE

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

SponsorPhase
University of North Carolina, Chapel HillPhase 4
Dow University of Health SciencesEarly Phase 1
Louisiana State University Health Sciences Center in New OrleansPhase 4

See all OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE clinical trials

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
St Renatus KOVANAZE oxymetazoline hydrochloride; tetracaine hydrochloride SPRAY, METERED;NASAL 208032-001 Jun 29, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Portugal 2413899 ⤷  Try a Trial
Mexico 2011010445 ANESTESICO DENTAL QUE COMPRENDE TETRACAINA Y UN VASOCONSTRICTOR PARA ADMINISTRACION INTRANASAL. (DENTAL ANESTHETIC COMPRISING TETRACAINE AND A VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION.) ⤷  Try a Trial
New Zealand 612063 Dental anesthetic comprising tetracaine and a vasoconstrictor for intranasal administration ⤷  Try a Trial
Japan 2015034167 鼻腔内投与用のテトラカインおよび血管収縮薬を含む歯科用麻酔剤 (DENTAL ANESTHETIC COMPRISING TETRACAINE AND VASOCONSTRICTOR FOR INTRANASAL ADMINISTRATION) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.