Ciprofloxacin hydrochloride; fluocinolone acetonide - Generic Drug Details
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What are the generic sources for ciprofloxacin hydrochloride; fluocinolone acetonide and what is the scope of freedom to operate?
Ciprofloxacin hydrochloride; fluocinolone acetonide
is the generic ingredient in one branded drug marketed by Laboratorios Salvat and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Ciprofloxacin hydrochloride; fluocinolone acetonide has eighteen patent family members in fifteen countries.
One supplier is listed for this compound.
Summary for ciprofloxacin hydrochloride; fluocinolone acetonide
International Patents: | 18 |
US Patents: | 1 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 1 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ciprofloxacin hydrochloride; fluocinolone acetonide |
DailyMed Link: | ciprofloxacin hydrochloride; fluocinolone acetonide at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ciprofloxacin hydrochloride; fluocinolone acetonide
Generic Entry Date for ciprofloxacin hydrochloride; fluocinolone acetonide*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION/DROPS;OTIC |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for ciprofloxacin hydrochloride; fluocinolone acetonide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Lee's Pharmaceutical Limited | Phase 3 |
See all ciprofloxacin hydrochloride; fluocinolone acetonide clinical trials
Anatomical Therapeutic Chemical (ATC) Classes for ciprofloxacin hydrochloride; fluocinolone acetonide
US Patents and Regulatory Information for ciprofloxacin hydrochloride; fluocinolone acetonide
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Laboratorios Salvat | OTOVEL | ciprofloxacin hydrochloride; fluocinolone acetonide | SOLUTION/DROPS;OTIC | 208251-001 | Apr 29, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
International Patents for ciprofloxacin hydrochloride; fluocinolone acetonide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 102811741 | Aqueous clear solutions of fluocinolone acetonide for treatment of otic inflammation | ⤷ Try a Trial |
Argentina | 080368 | DISOLUCIONES ACUOSAS TRANSPARENTES DE ACETONIDO DE FLUOCINOLONA PARA EL TRATAMIENTO DE LA INFLAMACION DE OIDO | ⤷ Try a Trial |
Russian Federation | 2012141641 | ВОДНЫЕ ПРОЗРАЧНЫЕ РАСТВОРЫ ФЛУОЦИНОЛОНА АЦЕТОНИДА ДЛЯ ЛЕЧЕНИЯ УШНОГО ВОСПАЛЕНИЯ | ⤷ Try a Trial |
Japan | 2013521245 | ⤷ Try a Trial | |
Denmark | 2366408 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ciprofloxacin hydrochloride; fluocinolone acetonide
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 |
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 |
1429780 | 132013902137451 | Italy | ⤷ Try a Trial | PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106 |
1429780 | 122012000070 | Germany | ⤷ Try a 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |