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Last Updated: September 25, 2022

XTORO Drug Patent Profile


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When do Xtoro patents expire, and what generic alternatives are available?

Xtoro is a drug marketed by Merlion Pharms Gmbh and is included in one NDA. There are four patents protecting this drug.

This drug has forty-two patent family members in eighteen countries.

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

DrugPatentWatch® Generic Entry Outlook for Xtoro

Xtoro was eligible for patent challenges on December 17, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 2, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for XTORO
International Patents:42
US Patents:4
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 35
Patent Applications: 120
DailyMed Link:XTORO at DailyMed
Drug patent expirations by year for XTORO
DrugPatentWatch® Estimated Generic Entry Opportunity Date for XTORO
Generic Entry Date for XTORO*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for XTORO

XTORO is protected by four US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XTORO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XTORO

Methods for treating ophthalmic, otic, or nasal infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACUTE OTITIS EXTERNA

Methods for treating otic infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACUTE OTITIS EXTERNA

Finafloxacin suspension compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACUTE OTITIS EXTERNA

Compositions and methods for treating ophthalmic, octic, or nasal infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merlion Pharms Gmbh XTORO finafloxacin SUSPENSION/DROPS;OTIC 206307-001 Dec 17, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Merlion Pharms Gmbh XTORO finafloxacin SUSPENSION/DROPS;OTIC 206307-001 Dec 17, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Merlion Pharms Gmbh XTORO finafloxacin SUSPENSION/DROPS;OTIC 206307-001 Dec 17, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Merlion Pharms Gmbh XTORO finafloxacin SUSPENSION/DROPS;OTIC 206307-001 Dec 17, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 XTORO

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 See Plans and Pricing See Plans and Pricing
Merlion Pharms Gmbh XTORO finafloxacin SUSPENSION/DROPS;OTIC 206307-001 Dec 17, 2014 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for XTORO

When does loss-of-exclusivity occur for XTORO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 7372
Estimated Expiration: See Plans and Pricing

Australia

Patent: 10266120
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 1016257
Estimated Expiration: See Plans and Pricing

Canada

Patent: 65852
Estimated Expiration: See Plans and Pricing

Chile

Patent: 11003327
Estimated Expiration: See Plans and Pricing

China

Patent: 2470139
Estimated Expiration: See Plans and Pricing

Patent: 5687111
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 48587
Estimated Expiration: See Plans and Pricing

Japan

Patent: 84012
Estimated Expiration: See Plans and Pricing

Patent: 12532115
Estimated Expiration: See Plans and Pricing

Patent: 15134827
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 12000136
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 70731
Estimated Expiration: See Plans and Pricing

Patent: 12103458
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1109492
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1541823
Estimated Expiration: See Plans and Pricing

Patent: 120114211
Estimated Expiration: See Plans and Pricing

Spain

Patent: 94775
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 60181
Estimated Expiration: See Plans and Pricing

Patent: 1102395
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 758
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XTORO around the world.

Country Patent Number Title Estimated Expiration
Russian Federation 2012103458 КОМПОЗИЦИИ, ВКЛЮЧАЮЩИЕ ФИНАФЛОКСАЦИИ, И СПОСОБЫ ЛЕЧЕНИЯ ОФТАЛЬМОЛОГИЧЕСКИХ, УШНЫХ ИЛИ НАЗАЛЬНЫХ ИНФЕКЦИЙ See Plans and Pricing
Brazil PI1016257 composições compreendendo finafloxacino e métodos para tratar infecções oftálmicas, ópticas ou nasais See Plans and Pricing
Ukraine 115454 КОМПОЗИЦІЯ ФІНАФЛОКСАЦИНУ У ВИГЛЯДІ СУСПЕНЗІЇ (FINAFLOXACIN SUSPENSION COMPOSITIONS) See Plans and Pricing
Hungary 0000450 See Plans and Pricing
China 100335054 See Plans and Pricing
Chile 2015001500 Composicion en suspensión topica de finafloxacina; metodo de preparacion y uso para el tratamiento de una infeccion oftalmica, otica o nasal. See Plans and Pricing
New Zealand 506162 Use of 7-(2-oxa-5,8-diazabicyclo[4.3.0]non-8-yl)-quinolonecarboxylic acid and -naphthyridonecarboxylic acid derivatives for the therapy of helicobacter pylori infections and the gastroduodenal disorders associated therewith See Plans and Pricing
>Country >Patent Number >Title >Estimated 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.