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Last Updated: April 16, 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. It is available from one supplier. 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. One supplier is listed 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^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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.

Pharmacology for NDA: 208945

Suppliers and Packaging for NDA: 208945

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XEPI	ozenoxacin	CREAM;TOPICAL	208945	NDA	Biofrontera Inc.	70621-103	70621-103-03	1 TUBE in 1 CELLO PACK (70621-103-03) / 3 g in 1 TUBE
XEPI	ozenoxacin	CREAM;TOPICAL	208945	NDA	Biofrontera Inc.	70621-103	70621-103-10	1 TUBE in 1 BOX (70621-103-10) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	1%
Approval Date:	Dec 11, 2017	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	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:	⤷ Try a Trial	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	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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