OZENOXACIN - Generic Drug Details

What are the generic drug sources for ozenoxacin and what is the scope of freedom to operate?

Ozenoxacin is the generic ingredient in one branded drug marketed by Ferrer Internacional and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ozenoxacin has thirty-seven patent family members in twenty-three countries.

There is one drug master file entry for ozenoxacin. One supplier is listed for this compound.

Summary for OZENOXACIN

International Patents:	37
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	2
Patent Applications:	136
What excipients (inactive ingredients) are in OZENOXACIN?	OZENOXACIN excipients list
DailyMed Link:	OZENOXACIN at DailyMed

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

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.

Recent Clinical Trials for OZENOXACIN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Ferrer Internacional S.A.	Phase 3

See all OZENOXACIN clinical trials

Pharmacology for OZENOXACIN

Drug Class

Quinolone Antimicrobial

US Patents and Regulatory Information for OZENOXACIN

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 OZENOXACIN

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 OZENOXACIN

Country	Patent Number	Title	Estimated Expiration
Chile	2011000848	Composicion de crema topica estable que comprende ozenoxacina y un excipiente farmaceuticamente adecuado y uso de la composicion para la erradicacion de infecciones nasofaringeas en portadores nasales asintomaticos, y para el tratamiento o prevencion de infecciones de la piel, del tracto genital, y enfermedades de transmision sexual.
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	20160025034	약학적 국부 조성물 (PHARMACEUTICAL TOPICAL COMPOSITIONS)
Hong Kong	1161552	PHARMACEUTICAL TOPICAL COMPOSITIONS
South Korea	20160116353	약학적 국부 조성물 (PHARMACEUTICAL TOPICAL COMPOSITIONS)
Spain	2437967

Supplementary Protection Certificates for OZENOXACIN

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