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Last Updated: November 2, 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 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 LARKEN LABS 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
Oregon Health and Science UniversityPhase 4
University of California, San FranciscoPhase 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 ⤷  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

Supplementary Protection Certificates for FLOXIN OTIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1429780 132013902137451 Italy ⤷  Sign Up PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
0206283 C980016 Netherlands ⤷  Sign Up PRODUCT NAME: LEVOFLOXACINE, DESGEWENST IN DE VORM VAN EEN SOLVAAT, IN HET BIJZONDER LEVOFLOXACINE-HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 21810 - RVG 21812 19971209; FIRST REGISTRATION: GB 13402/0011 - 13402/0013 19970606
1429780 SPC/GB12/058 United Kingdom ⤷  Sign Up PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003
1429780 122012000070 Germany ⤷  Sign Up PRODUCT NAME: KOMBINATION AUS CIPROFLOXACIN UND DEXAMETHASON, INSBESONDERE CIPROFLOXACINHYDROCHLORID UND DEXAMETHASON; NAT. REGISTRATION NO/DATE: 85150.00. 00 20120830; FIRST REGISTRATION: DAENEMARK 48976 20120808
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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