➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKinsey
Merck
Mallinckrodt
Express Scripts
Colorcon
Medtronic

Last Updated: October 18, 2021

DrugPatentWatch Database Preview

Ciprofloxacin hydrochloride; fluocinolone acetonide - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

What are the generic drug 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.

There are thirty-four drug master file entries for ciprofloxacin hydrochloride; fluocinolone acetonide. Four suppliers are listed for this compound.

Summary for ciprofloxacin hydrochloride; fluocinolone acetonide
Recent Clinical Trials for ciprofloxacin hydrochloride; fluocinolone acetonide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Lee's Pharmaceutical LimitedPhase 3

See all ciprofloxacin hydrochloride; fluocinolone acetonide clinical trials

Pharmacology 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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  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 ciprofloxacin hydrochloride; fluocinolone acetonide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1429780 SPC/GB12/058 United Kingdom ⤷  Free Forever 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 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
1429780 132013902137451 Italy ⤷  Free Forever Trial PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Merck
Mallinckrodt
Express Scripts
Colorcon
Medtronic

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.