Details for New Drug Application (NDA): 208945
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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: | RX | Dosage: | CREAM;TOPICAL | Strength | 1% | ||||
Approval Date: | Dec 11, 2017 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jan 29, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 15, 2029 | Product 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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