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Last Updated: September 21, 2021

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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 two suppliers. There are three 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. Two suppliers are listed for this compound. Additional details are available on the ozenoxacin profile page.
Summary for 208945
Applicant:Ferrer Internacional
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 208945
Generic Entry Date for 208945*:
Constraining patent/regulatory exclusivity:

*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 Cutanea Life Sciences, Inc. 70363-011 70363-011-04 1 TUBE in 1 BOX (70363-011-04) > 3 g in 1 TUBE
XEPI ozenoxacin CREAM;TOPICAL 208945 NDA Cutanea Life Sciences, Inc. 70363-011 70363-011-30 1 TUBE in 1 BOX (70363-011-30) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Dec 11, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 11, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Try it FreePatent Expiration:Nov 9, 2023Product Flag?Substance Flag?YDelist Request?
Patent:⤷  Try it FreePatent Expiration:Jan 29, 2032Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

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