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Last Updated: November 24, 2020

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Ozenoxacin - Generic Drug Details

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What are the generic drug sources for ozenoxacin and what is the scope of patent protection?

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

Ozenoxacin has fifty patent family members in twenty-five countries.

There is one drug master file entry for ozenoxacin. Two suppliers are listed for this compound.

Summary for ozenoxacin
International Patents:50
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Suppliers / Packagers: 2
Bulk Api Vendors: 30
Clinical Trials: 2
Patent Applications: 17
DailyMed Link:ozenoxacin at DailyMed
Recent Clinical Trials for ozenoxacin

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

SponsorPhase
Ferrer Internacional S.A.Phase 3

See all ozenoxacin clinical trials

Pharmacology for ozenoxacin

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   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
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
>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 ozenoxacin

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 132017000093887 Italy   Start Trial PRODUCT NAME: OZENOXACIN(DUBINE); AUTHORISATION NUMBER(S) AND DATE(S): ES/H/414/01/DC, 20170519;045237017, 20170711
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 2017C/031 Belgium   Start Trial PRODUCT NAME: OZENOXACINE; AUTHORISATION NUMBER AND DATE: BE509591 20170519
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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