Details for New Drug Application (NDA): 206307

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NDA 206307 describes XTORO, which is a drug marketed by Fonseca Biosciences and is included in one NDA. There are four patents protecting this drug. Additional details are available on the XTORO profile page.

The generic ingredient in XTORO is finafloxacin. Additional details are available on the finafloxacin profile page.

Summary for 206307

Tradename:	XTORO
Applicant:	Fonseca Biosciences
Ingredient:	finafloxacin
Patents:	4

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 206307

Generic Entry Date for 206307^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 9,119,859 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.

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION/DROPS;OTIC			Strength	0.3%
Approval Date:	Dec 17, 2014	TE:		RLD:	Yes
Patent:	8,536,167	Patent Expiration:	Aug 8, 2031	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ACUTE OTITIS EXTERNA
Patent:	9,119,859	Patent Expiration:	Jul 2, 2030	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ACUTE OTITIS EXTERNA
Patent:	9,504,691	Patent Expiration:	Nov 21, 2033	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ACUTE OTITIS EXTERNA

Expired US Patents for NDA 206307

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fonseca Biosciences	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014	6,133,260	⤷ Subscribe
Fonseca Biosciences	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014	6,432,948	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent 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.

Summary for 206307

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206307

Profile for product number 001

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 206307