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 |
| Winston Chamberlain, MD, PhD | Phase 4 |
| Stanford University | 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 |
|---|---|---|---|
| Philippines | 26367 | Topical preparation for treating otopathy | ⤷ Try a Trial |
| New Zealand | 228632 | TOPICAL OTOPATHIC PREPARATIONS CONTAINING OFLOXACIN | ⤷ Try a Trial |
| South Africa | 8902449 | ⤷ Try a Trial | |
| Germany | 68917186 | ⤷ 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 | 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 |
| 0206283 | 98C0041 | Belgium | ⤷ Try a Trial | PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606 |
| 0413455 | 98C0040 | Belgium | ⤷ Try a 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 |
Make Better Decisions: Try a trial or see plans & pricing
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.
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