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Last Updated: December 22, 2024

FLOXIN OTIC Drug Patent Profile


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Which patents cover Floxin Otic, and what generic alternatives are available?

Floxin Otic is a drug marketed by Daiichi and is included in one NDA.

The generic ingredient in FLOXIN OTIC is ofloxacin. There are seventy-eight drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Floxin Otic

A generic version of FLOXIN OTIC was approved as ofloxacin by CHARTWELL RX on September 2nd, 2003.

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Summary for FLOXIN OTIC
Drug patent expirations by year for FLOXIN OTIC
Recent Clinical Trials for FLOXIN OTIC

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

SponsorPhase
Montefiore Medical CenterPhase 3
Winston Chamberlain, MD, PhDPhase 4
Stanford UniversityPhase 4

See all FLOXIN OTIC clinical trials

US Patents and Regulatory Information for FLOXIN OTIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Daiichi FLOXIN OTIC ofloxacin SOLUTION/DROPS;OTIC 020799-001 Dec 16, 1997 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>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 FLOXIN OTIC

See the table below for patents covering FLOXIN OTIC around the world.

Country Patent Number Title Estimated Expiration
Ireland 65859 Use of ofloxacin or a salt thereof for preparing a topical preparation for treating otopathy ⤷  Subscribe
Hungary 9500407 ⤷  Subscribe
Canada 1330946 PREPARATION TOPIQUE POUR LE TRAITEMENT DE L'OTOPATHIE CONTENANT DE L'OFLOXACINE OU UN DE SES SELS (TOPICAL PREPARATION FOR TREATING OTOPATHY CONTAINING OFLOXACIN OR A SALT THEREOF) ⤷  Subscribe
South Korea 0126471 ⤷  Subscribe
Hong Kong 196596 Use of ofloxacin or a salt thereof for preparing a topical preparation for treating otopathy ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FLOXIN OTIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0413455 98C0040 Belgium ⤷  Subscribe PRODUCT NAME: ALATROFLOXACIN; NAT. REGISTRATION NO/DATE: EU/1/98/060/001 19980327; FIRST REGISTRATION: CH 54484 19980327
1429780 13C0012 France ⤷  Subscribe PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
0206283 SPC/GB97/085 United Kingdom ⤷  Subscribe PRODUCT NAME: LEVOFLOXACIN, OPTIONALLY IN THE FORM OF A HEMIHYDRATE; REGISTERED: UK 13402/0011 19970606; UK 13402/0012 19970606; UK 13402/0013 19970606
1429780 122012000070 Germany ⤷  Subscribe PRODUCT NAME: KOMBINATION AUS CIPROFLOXACIN UND DEXAMETHASON, INSBESONDERE CIPROFLOXACINHYDROCHLORID UND DEXAMETHASON; NAT. REGISTRATION NO/DATE: 85150.00. 00 20120830; FIRST REGISTRATION: DAENEMARK 48976 20120808
0206283 98C0041 Belgium ⤷  Subscribe PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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