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^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 9,180,200 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:	DISCN	Dosage:	CREAM;TOPICAL			Strength	1%
Approval Date:	Dec 11, 2017	TE:		RLD:	Yes
Patent:	9,180,200	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:	9,399,014	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferrer Internacional	XEPI	ozenoxacin	CREAM;TOPICAL	208945-001	Dec 11, 2017	6,335,447	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Summary for 208945

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208945

Profile for product number 001

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 208945