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Last Updated: September 26, 2022

XEPI Drug Patent 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. One supplier is listed for this compound. Additional details are available on the ozenoxacin profile page.

DrugPatentWatch® Generic Entry Outlook for Xepi

Xepi was eligible for patent challenges on December 11, 2021.

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
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 45
Patent Applications: 80
What excipients (inactive ingredients) are in XEPI?XEPI excipients list
DailyMed Link:XEPI at DailyMed
Drug patent expirations by year for XEPI
DrugPatentWatch® Estimated 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

XEPI is protected by three US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XEPI is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XEPI

Quinolonecarboxylic acid derivatives or salts thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical topical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES

Pharmaceutical topical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES

FDA Regulatory Exclusivity protecting XEPI

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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

International Patents for XEPI

When does loss-of-exclusivity occur for XEPI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 3901
Estimated Expiration: See Plans and Pricing

Australia

Patent: 09305360
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0920355
Estimated Expiration: See Plans and Pricing

Canada

Patent: 38384
Estimated Expiration: See Plans and Pricing

Patent: 22167
Estimated Expiration: See Plans and Pricing

Chile

Patent: 11000848
Estimated Expiration: See Plans and Pricing

Patent: 15002899
Estimated Expiration: See Plans and Pricing

China

Patent: 2186460
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 14838
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 44130
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 77208
Estimated Expiration: See Plans and Pricing

Patent: 44130
Estimated Expiration: See Plans and Pricing

Patent: 70117
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 61552
Estimated Expiration: See Plans and Pricing

Japan

Patent: 09209
Estimated Expiration: See Plans and Pricing

Patent: 73120
Estimated Expiration: See Plans and Pricing

Patent: 12505867
Estimated Expiration: See Plans and Pricing

Patent: 14088456
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 8029
Estimated Expiration: See Plans and Pricing

Patent: 11004052
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 0884
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 014502425
Estimated Expiration: See Plans and Pricing

Poland

Patent: 44130
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 44130
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 78367
Estimated Expiration: See Plans and Pricing

Patent: 11119764
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 44130
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1682256
Estimated Expiration: See Plans and Pricing

Patent: 110071086
Estimated Expiration: See Plans and Pricing

Patent: 160025034
Estimated Expiration: See Plans and Pricing

Patent: 160116353
Estimated Expiration: See Plans and Pricing

Spain

Patent: 37967
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 04418
Estimated Expiration: See Plans and Pricing

Patent: 1018497
Estimated Expiration: See Plans and Pricing

Patent: 1511779
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 187
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XEPI around the world.

Country Patent Number Title Estimated Expiration
China 1152029 See Plans and Pricing
Hong Kong 1161552 PHARMACEUTICAL TOPICAL COMPOSITIONS See Plans and Pricing
Japan 5873120 See Plans and Pricing
Netherlands 300884 See Plans and Pricing
South Korea 20160025034 약학적 국부 조성물 (PHARMACEUTICAL TOPICAL COMPOSITIONS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XEPI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2344130 2017/038 Ireland See Plans and Pricing PRODUCT NAME: OZENOXACIN; NAT REGISTRATION NO/DATE: PA1744/003/001 20170616; FIRST REGISTRATION NO/DATE: ES/H/414/01/DC 20170519
2344130 C201730036 Spain See Plans and Pricing 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 300884 Netherlands See Plans and Pricing PRODUCT NAME: OZENOXACIN; REGISTRATION NO/DATE: ES/H/414/1/DC 20170519
2344130 2017C/031 Belgium See Plans and Pricing PRODUCT NAME: OZENOXACINE; AUTHORISATION NUMBER AND DATE: BE509591 20170519
2344130 132017000093887 Italy See Plans and Pricing PRODUCT NAME: OZENOXACIN(DUBINE); AUTHORISATION NUMBER(S) AND DATE(S): ES/H/414/01/DC, 20170519;045237017, 20170711
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Merck
Baxter
McKesson
Express Scripts
Dow

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.