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 Fonseca Biosciences 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
Summary for XTORO
| International Patents: | 42 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 44 |
| Patent Applications: | 101 |
| DailyMed Link: | XTORO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACUTE OTITIS EXTERNA
Methods for treating otic infections
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACUTE OTITIS EXTERNA
Finafloxacin suspension compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACUTE OTITIS EXTERNA
Compositions and methods for treating ophthalmic, octic, or nasal infections
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fonseca Biosciences | XTORO | finafloxacin | SUSPENSION/DROPS;OTIC | 206307-001 | Dec 17, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Fonseca Biosciences | XTORO | finafloxacin | SUSPENSION/DROPS;OTIC | 206307-001 | Dec 17, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Fonseca Biosciences | XTORO | finafloxacin | SUSPENSION/DROPS;OTIC | 206307-001 | Dec 17, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| >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 |
|---|---|---|---|---|---|---|---|
| Fonseca Biosciences | XTORO | finafloxacin | SUSPENSION/DROPS;OTIC | 206307-001 | Dec 17, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Fonseca Biosciences | XTORO | finafloxacin | SUSPENSION/DROPS;OTIC | 206307-001 | Dec 17, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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: ⤷ Try a Trial
Australia
Patent: 10266120
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 1016257
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 65852
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 11003327
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2470139
Estimated Expiration: ⤷ Try a Trial
Patent: 5687111
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 48587
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 84012
Estimated Expiration: ⤷ Try a Trial
Patent: 12532115
Estimated Expiration: ⤷ Try a Trial
Patent: 15134827
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 12000136
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 70731
Estimated Expiration: ⤷ Try a Trial
Patent: 12103458
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1109492
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1541823
Estimated Expiration: ⤷ Try a Trial
Patent: 120114211
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 94775
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 60181
Estimated Expiration: ⤷ Try a Trial
Patent: 1102395
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 758
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| Germany | 19652239 | ⤷ Try a Trial | |
| Turkey | 9901754 | ⤷ Try a Trial | |
| Canada | 2888641 | COMPOSITIONS DE SUSPENSION DE FINAFLOXACINE (FINAFLOXACIN SUSPENSION COMPOSITIONS) | ⤷ Try a Trial |
| >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.
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