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Last Updated: November 7, 2024

Ozenoxacin - Generic Drug Details


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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.

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: 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
Generic Entry Date for ozenoxacin*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
Ferrer Internacional S.A.Phase 3

See all ozenoxacin clinical trials

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

Country Patent Number Title Estimated Expiration
Japan 5873120 ⤷  Sign Up
Canada 2738384 COMPOSITIONS TOPIQUES PHARMACEUTIQUES (PHARMACEUTICAL TOPICAL COMPOSITIONS) ⤷  Sign Up
European Patent Office 2177208 Compositions pharmaceutiques topiques (Pharmaceutical topical compositions) ⤷  Sign Up
South Korea 20160025034 약학적 국부 조성물 (PHARMACEUTICAL TOPICAL COMPOSITIONS) ⤷  Sign Up
Spain 2437967 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ozenoxacin

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

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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.