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 Lnhc 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.

Summary for OZENOXACIN

International Patents:	37
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	2
Patent Applications:	321
What excipients (inactive ingredients) are in OZENOXACIN?	OZENOXACIN excipients list
DailyMed Link:	OZENOXACIN at DailyMed

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

Constraining patent/regulatory exclusivity:

9,399,014

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

Anatomical Therapeutic Chemical (ATC) Classes for OZENOXACIN

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 OZENOXACIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lnhc	XEPI	ozenoxacin	CREAM;TOPICAL	208945-001	Dec 11, 2017		DISCN	Yes	No	9,399,014
Lnhc	XEPI	ozenoxacin	CREAM;TOPICAL	208945-001	Dec 11, 2017		DISCN	Yes	No	9,180,200		Y

Expired US Patents for OZENOXACIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lnhc	XEPI	ozenoxacin	CREAM;TOPICAL	208945-001	Dec 11, 2017	6,335,447

International Patents for OZENOXACIN

Country	Patent Number	Title	Estimated Expiration
Argentina	073901
Australia	2009305360
Brazil	PI0920355
Canada	2738384

Supplementary Protection Certificates for OZENOXACIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	300884	Netherlands		PRODUCT NAME: OZENOXACIN; REGISTRATION NO/DATE: ES/H/414/1/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	2017C/031	Belgium		PRODUCT NAME: OZENOXACINE; AUTHORISATION NUMBER AND DATE: BE509591 20170519