Last Updated: August 9, 2026

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. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the XTORO profile page.

The generic ingredient in XTORO is finafloxacin. One supplier is listed for this compound. 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^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: ⤷ Start Trial 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.

Pharmacology for NDA: 206307

Suppliers and Packaging for NDA: 206307

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307	NDA	Fonseca Biosciences, LLC	83709-001	83709-001-01	1 BOTTLE, DROPPER in 1 CARTON (83709-001-01) / 5 mL in 1 BOTTLE, DROPPER
XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307	NDA	Fonseca Biosciences, LLC	83709-001	83709-001-90	1 POUCH in 1 CARTON (83709-001-90) / 1 BOTTLE, DROPPER in 1 POUCH / 1.5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION/DROPS;OTIC			Strength	0.3%
Approval Date:	Dec 17, 2014	TE:		RLD:	Yes
Patent:	⤷ Start Trial	Patent Expiration:	Aug 8, 2031	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ACUTE OTITIS EXTERNA
Patent:	⤷ Start Trial	Patent Expiration:	Jul 2, 2030	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ACUTE OTITIS EXTERNA
Patent:	⤷ Start Trial	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	⤷ Start Trial	⤷ Start Trial
Fonseca Biosciences	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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