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-six 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.
Summary for FLOXIN OTIC
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 167 |
Clinical Trials: | 8 |
Patent Applications: | 4,135 |
Formulation / Manufacturing: | see details |
DailyMed Link: | FLOXIN OTIC at DailyMed |
Recent Clinical Trials for FLOXIN OTIC
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Montefiore Medical Center | Phase 3 |
Oregon Health and Science University | Phase 4 |
University of California, San Francisco | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for FLOXIN OTIC
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for FLOXIN OTIC
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Daiichi | FLOXIN OTIC | ofloxacin | SOLUTION/DROPS;OTIC | 020799-001 | Dec 16, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 | ⤷ Try a Trial |
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) | ⤷ Try a Trial |
Japan | H0334925 | LOCAL PREPARATION FOR EAR DISEASE | ⤷ Try a Trial |
Ireland | 891118 | ⤷ Try a Trial | |
New Zealand | 228632 | TOPICAL OTOPATHIC PREPARATIONS CONTAINING OFLOXACIN | ⤷ Try a Trial |
Hong Kong | 196596 | Use of ofloxacin or a salt thereof for preparing a topical preparation for treating otopathy | ⤷ Try a Trial |
Denmark | 175302 | ⤷ Try a Trial | |
>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 | ⤷ Try a Trial | 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 |
0413455 | 98C0040 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ALATROFLOXACIN; NAT. REGISTRATION NO/DATE: EU/1/98/060/001 19980327; FIRST REGISTRATION: CH 54484 19980327 |
1429780 | 132013902137451 | Italy | ⤷ Try a Trial | PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106 |
0206283 | C980016 | Netherlands | ⤷ Try a 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 | ⤷ Try a Trial | PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606 |
1429780 | 13C0012 | France | ⤷ Try a 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 |
0206283 | SPC/GB97/085 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: LEVOFLOXACIN, OPTIONALLY IN THE FORM OF A HEMIHYDRATE; REGISTERED: UK 13402/0011 19970606; UK 13402/0012 19970606; UK 13402/0013 19970606 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |