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Last Updated: November 21, 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-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 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
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

International Patents for FLOXIN OTIC

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

Country Patent Number Title Estimated Expiration
European Patent Office 0337328 Utilisation de l'ofloxacine ou de l'un de ses sels pour prĂ©parer une prĂ©paration topicale pour le traitement des otopathies. (Use of ofloxacin or a salt thereof for preparing a topical preparation for treating otopathy.) ⤷  Sign Up
Denmark 175302 ⤷  Sign Up
Australia 3256789 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for FLOXIN OTIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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
>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.