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Last Updated: July 30, 2021

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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. Twenty-one 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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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
Genentech, Inc.Phase 4
University of Colorado, DenverPhase 4

See all FLOXIN OTIC clinical trials

Paragraph IV (Patent) Challenges for FLOXIN OTIC
Tradename Dosage Ingredient NDA Submissiondate
FLOXIN OTIC SOLUTION/DROPS;OTIC ofloxacin 020799

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 ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 FLOXIN OTIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0206283 C980016 Netherlands ⤷  Free Forever Trial 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
0206283 98C0041 Belgium ⤷  Free Forever Trial PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606
1429780 13C0012 France ⤷  Free Forever Trial 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
1429780 122012000070 Germany ⤷  Free Forever Trial PRODUCT NAME: KOMBINATION AUS CIPROFLOXACIN UND DEXAMETHASON, INSBESONDERE CIPROFLOXACINHYDROCHLORID UND DEXAMETHASON; NAT. REGISTRATION NO/DATE: 85150.00. 00 20120830; FIRST REGISTRATION: DAENEMARK 48976 20120808
0413455 98C0040 Belgium ⤷  Free Forever Trial PRODUCT NAME: ALATROFLOXACIN; NAT. REGISTRATION NO/DATE: EU/1/98/060/001 19980327; FIRST REGISTRATION: CH 54484 19980327
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
AstraZeneca
Medtronic
Colorcon
Boehringer Ingelheim
Mallinckrodt

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