Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: September 18, 2019

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:DISCNDosage: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:  Try a Free TrialPatent 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   Try a Free Trial   Try a Free Trial
Merlion Pharms Gmbh XTORO finafloxacin SUSPENSION/DROPS;OTIC 206307-001 Dec 17, 2014   Try a Free Trial   Try a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Mallinckrodt
Teva
Citi
Healthtrust
Argus Health

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 verifification 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.