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Generated: September 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206307

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NDA 206307 describes XTORO, which is a drug marketed by Merlion Pharms Gmbh and is included in one NDA. There are three 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:Merlion Pharms Gmbh
Ingredient:finafloxacin
Patents:3
Generic Entry Opportunity Date for 206307
Generic Entry Date for 206307*:
Constraining patent/regulatory exclusivity:
PEDIATRIC 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.

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OTICStrength0.3%
Approval Date:Dec 17, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 17, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jun 17, 2020
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:➤ Sign UpPatent Expiration:Aug 8, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACUTE OTITIS EXTERNA

Expired US Patents for NDA 206307

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merlion Pharms Gmbh XTORO finafloxacin SUSPENSION/DROPS;OTIC 206307-001 Dec 17, 2014 ➤ Sign Up ➤ Sign Up
Merlion Pharms Gmbh XTORO finafloxacin SUSPENSION/DROPS;OTIC 206307-001 Dec 17, 2014 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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