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XEPI Drug Patent Profile

Which patents cover Xepi, and when can generic versions of Xepi launch?

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

This drug has thirty-seven patent family members in twenty-three 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

Summary for XEPI

International Patents:	37
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Patent Applications:	58
What excipients (inactive ingredients) are in XEPI?	XEPI excipients list
DailyMed Link:	XEPI at DailyMed

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

NDA:

208945

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

Drug Class

Quinolone Antimicrobial

Anatomical Therapeutic Chemical (ATC) Classes for XEPI

D06AX	Other antibiotics for topical use
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

US Patents and Regulatory Information for XEPI

XEPI is protected by two US patents.

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

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
Ferrer Internacional	XEPI	ozenoxacin	CREAM;TOPICAL	208945-001	Dec 11, 2017		RX	Yes	Yes			Y

Expired US Patents for XEPI

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

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

Australia

Brazil

Canada

Chile

China

Cyprus

Denmark

European Patent Office

Hong Kong

Japan

Mexico

Netherlands

Philippines

Poland

Portugal

Russian Federation

Slovenia

South Korea

Spain

Taiwan

Uruguay

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
Uruguay	32187	COMPOSICIONES FARMACEUTICAS TOPICAS
Cyprus	1114838
Russian Federation	2478367	СТАБИЛЬНАЯ КОМПОЗИЦИЯ (ВАРИАНТЫ), ЛЕКАРСТВЕННОЕ СРЕДСТВО (ВАРИАНТЫ) И СПОСОБЫ ЛЕЧЕНИЯ И ПРОФИЛАКТИКИ КОЖНЫХ ИНФЕКЦИЙ И ИНФЕКЦИЙ КОЖНЫХ СТРУКТУР, ВЫЗВАННЫХ БАКТЕРИЯМИ, ЗАБОЛЕВАНИЙ, ПЕРЕДАЮЩИХСЯ ПОЛОВЫМ ПУТЕМ, И ИНФЕКЦИЙ ПОЛОВЫХ ПУТЕЙ, ВЫЗВАННЫХ БАКТЕРИЯМИ, И ИНФЕКЦИЙ НОСОГЛОТКИ, ВЫЗВАННЫХ БАКТЕРИЯМИ, У ЧЕЛОВЕКА ИЛИ ЖИВОТНОГО (STABLE COMPOSITION (VERSIONS), MEDICATION (VERSIONS) AND METHODS OF TREATMENT AND PREVENTION OF SKIN INFECTIONS AND INFECTIONS OF SKIN STRUCTURES, CAUSED BY BACTERIA, SEXUALLY TRANSMITTED DISEASES AND INFECTIONS OF REPRODUCTIVE TRACT, CAUSED BY BACTERIA, NASOPHARYNGEAL INFECTIONS, CAUSED BY BACTERIA, IN HUMANS OR ANIMALS)
Mexico	338029	COMPOSICIONES FARMACEUTICAS TOPICAS. (PHARMACEUTICAL TOPICAL COMPOSITIONS.)
Russian Federation	2011119764	СТАБИЛЬНАЯ КОМПОЗИЦИЯ (ВАРИАНТЫ), ЛЕКАРСТВЕННОЕ СРЕДСТВО (ВАРИАНТЫ) И СПОСОБЫ ЛЕЧЕНИЯ И ПРОФИЛАКТИКИ КОЖНЫХ ИНФЕКЦИЙ И ИНФЕКЦИЙ КОЖНЫХ СТРУКТУР, ЗАБОЛЕВАНИЙ, ПЕРЕДАЮЩИХСЯ ПОЛОВЫМ ПУТЕМ И ИНФЕКЦИЙ ПОЛОВЫХ ПУТЕЙ, ИНФЕКЦИЙ НОСОГЛОТКИ У ЧЕЛОВЕКА ИЛИ ЖИВОТНОГО
South Korea	101682256
Portugal	2344130

Supplementary Protection Certificates for XEPI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2344130	132017000093887	Italy		PRODUCT NAME: OZENOXACIN(DUBINE); AUTHORISATION NUMBER(S) AND DATE(S): ES/H/414/01/DC, 20170519;045237017, 20170711
2344130	2017C/031	Belgium		PRODUCT NAME: OZENOXACINE; AUTHORISATION NUMBER AND DATE: BE509591 20170519
2344130	300884	Netherlands		PRODUCT NAME: OZENOXACIN; REGISTRATION NO/DATE: ES/H/414/1/DC 20170519
2344130	2017/038	Ireland		PRODUCT NAME: OZENOXACIN; NAT REGISTRATION NO/DATE: PA1744/003/001 20170616; FIRST REGISTRATION NO/DATE: ES/H/414/01/DC 20170519
2344130	C201730036	Spain		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	1790031-7	Sweden		PRODUCT NAME: OZENOXACIN; NAT. REG. NO/DATE: 54608 20170622; FIRST REG.: BE ES/H/414/01/DC 20170519
2344130	122017000073	Germany		PRODUCT NAME: OZENOXACIN; NAT. REGISTRATION NO/DATE: 97303.00.00 20170803; FIRST REGISTRATION: BELGIEN BE509591 20170517