Details for New Drug Application (NDA): 206307
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The generic ingredient in XTORO is finafloxacin. 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*:
Constraining patent/regulatory 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: | DISCN | Dosage: | SUSPENSION/DROPS;OTIC | Strength | 0.3% | ||||
Approval Date: | Dec 17, 2014 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 8, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF ACUTE OTITIS EXTERNA | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jul 2, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF ACUTE OTITIS EXTERNA | ||||||||
Patent: | ⤷ Sign Up | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Fonseca Biosciences | XTORO | finafloxacin | SUSPENSION/DROPS;OTIC | 206307-001 | Dec 17, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Fonseca Biosciences | 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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