Finafloxacin - Generic Drug Details
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What are the generic drug sources for finafloxacin and what is the scope of freedom to operate?
Finafloxacin
is the generic ingredient in one branded drug marketed by Fonseca Biosciences and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Finafloxacin has forty-two patent family members in eighteen countries.
Summary for finafloxacin
International Patents: | 42 |
US Patents: | 4 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 44 |
Clinical Trials: | 7 |
Patent Applications: | 178 |
DailyMed Link: | finafloxacin at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for finafloxacin
Generic Entry Date for finafloxacin*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION/DROPS;OTIC |
*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 finafloxacin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
MerLion Pharmaceuticals GmbH | Phase 2 |
MerLion Pharmaceuticals GmbH | Phase 1 |
US Patents and Regulatory Information for finafloxacin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Fonseca Biosciences | XTORO | finafloxacin | SUSPENSION/DROPS;OTIC | 206307-001 | Dec 17, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Fonseca Biosciences | XTORO | finafloxacin | SUSPENSION/DROPS;OTIC | 206307-001 | Dec 17, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Fonseca Biosciences | XTORO | finafloxacin | SUSPENSION/DROPS;OTIC | 206307-001 | Dec 17, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Fonseca Biosciences | XTORO | finafloxacin | SUSPENSION/DROPS;OTIC | 206307-001 | Dec 17, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
Expired US Patents for finafloxacin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Fonseca Biosciences | XTORO | finafloxacin | SUSPENSION/DROPS;OTIC | 206307-001 | Dec 17, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Fonseca Biosciences | XTORO | finafloxacin | SUSPENSION/DROPS;OTIC | 206307-001 | Dec 17, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for finafloxacin
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Chile | 2015001500 | Composicion en suspensión topica de finafloxacina; metodo de preparacion y uso para el tratamiento de una infeccion oftalmica, otica o nasal. | ⤷ Try a Trial |
China | 102470139 | Compositions comprising finafloxacin and methods for treating ophthalmic, otic, or nasal infections | ⤷ Try a Trial |
Chile | 2011003327 | Composicion farmaceutica que comprende finafloxacina y un agente antiinflamatorio; uso en el tratamiento de infecciones oftalmicas, oticas o nasales. | ⤷ Try a Trial |
Russian Federation | 2012103458 | КОМПОЗИЦИИ, ВКЛЮЧАЮЩИЕ ФИНАФЛОКСАЦИИ, И СПОСОБЫ ЛЕЧЕНИЯ ОФТАЛЬМОЛОГИЧЕСКИХ, УШНЫХ ИЛИ НАЗАЛЬНЫХ ИНФЕКЦИЙ | ⤷ Try a Trial |
China | 105687111 | 用于治疗眼、耳或鼻感染的包含非那沙星的组合物和方法 (Compositions and methods for treating ophthalmic, otic, or nasal infections) | ⤷ Try a Trial |
China | 109908081 | 非那沙星混悬液组合物 (Finafloxacin suspension compositions) | ⤷ Try a Trial |
Mexico | 2015007182 | COMPOSICIONES EN SUSPENSION DE FINAFLOXACINA. (FINAFLOXACIN SUSPENSION COMPOSITIONS.) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |