Details for New Drug Application (NDA): 206307
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NDA 206307 describes XTORO, which is a drug marketed by Fonseca Biosciences and is included in one NDA. There are four 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.
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: | ⤷ Try a Trial | Patent Expiration: | Aug 8, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ACUTE OTITIS EXTERNA | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 2, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ACUTE OTITIS EXTERNA | ||||||||
| Patent: | ⤷ Try a Trial | 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 | ⤷ 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 |
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