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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 208945


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NDA 208945 describes XEPI, which is a drug marketed by Ferrer Internacional and is included in one NDA. There are two patents protecting this drug. Additional details are available on the XEPI profile page.

The generic ingredient in XEPI is ozenoxacin. There is one drug master file entry for this compound. Additional details are available on the ozenoxacin profile page.
Summary for 208945
Tradename:XEPI
Applicant:Ferrer Internacional
Ingredient:ozenoxacin
Patents:2
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208945
Generic Entry Date for 208945*:
Constraining patent/regulatory exclusivity:
Dosage:
CREAM;TOPICAL

*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:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Dec 11, 2017TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jan 29, 2032Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES
Patent:⤷  Sign UpPatent Expiration:Dec 15, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES

Expired US Patents for NDA 208945

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ferrer Internacional XEPI ozenoxacin CREAM;TOPICAL 208945-001 Dec 11, 2017 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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