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Last Updated: October 23, 2020

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XEPI Drug Profile

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When do Xepi patents expire, and what generic alternatives are available?

Xepi is a drug marketed by Ferrer Internacional and is included in one NDA. There are three patents protecting this drug.

This drug has fifty patent family members in twenty-five countries.

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.

US ANDA Litigation and Generic Entry Outlook for Xepi

Xepi will be eligible for patent challenges on December 11, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 29, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for XEPI
International Patents:50
US Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: 2
Bulk Api Vendors: 30
Patent Applications: 10
DailyMed Link:XEPI at DailyMed
Drug patent expirations by year for XEPI
Generic Entry Opportunity Date for XEPI
Generic Entry Date for XEPI*:
Constraining patent/regulatory exclusivity:
NDA:
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 XEPI

US Patents and Regulatory Information for XEPI

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ferrer Internacional XEPI ozenoxacin CREAM;TOPICAL 208945-001 Dec 11, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Ferrer Internacional XEPI ozenoxacin CREAM;TOPICAL 208945-001 Dec 11, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Ferrer Internacional XEPI ozenoxacin CREAM;TOPICAL 208945-001 Dec 11, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Ferrer Internacional XEPI ozenoxacin CREAM;TOPICAL 208945-001 Dec 11, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for XEPI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2344130 300884 Netherlands   Start Trial PRODUCT NAME: OZENOXACIN; REGISTRATION NO/DATE: ES/H/414/1/DC 20170519
2344130 1790031-7 Sweden   Start Trial PRODUCT NAME: OZENOXACIN; NAT. REG. NO/DATE: 54608 20170622; FIRST REG.: BE ES/H/414/01/DC 20170519
2344130 132017000093887 Italy   Start Trial PRODUCT NAME: OZENOXACIN(DUBINE); AUTHORISATION NUMBER(S) AND DATE(S): ES/H/414/01/DC, 20170519;045237017, 20170711
2344130 2017C/031 Belgium   Start Trial PRODUCT NAME: OZENOXACINE; AUTHORISATION NUMBER AND DATE: BE509591 20170519
2344130 C201730036 Spain   Start Trial PRODUCT NAME: OZENOXACINO; NATIONAL AUTHORISATION NUMBER: 82357-ES/H/0414/001/DC; DATE OF AUTHORISATION: 20170830; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): ES/H/414/01/DC; DATE OF FIRST AUTHORISATION IN EEA: 20170519
2344130 122017000073 Germany   Start Trial PRODUCT NAME: OZENOXACIN; NAT. REGISTRATION NO/DATE: 97303.00.00 20170803; FIRST REGISTRATION: BELGIEN BE509591 20170517
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.