Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
Medtronic
Mallinckrodt
Moodys
McKesson

Last Updated: November 13, 2019

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Ciprofloxacin hydrochloride; fluocinolone acetonide - Generic Drug Details

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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 seventeen patent family members in fourteen countries.

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

Summary for ciprofloxacin hydrochloride; fluocinolone acetonide
International Patents:17
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 34
Suppliers / Packagers: 2
DailyMed Link:ciprofloxacin hydrochloride; fluocinolone acetonide at DailyMed
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   Start Trial   Start Trial Y   Start Trial
Laboratorios Salvat OTOVEL ciprofloxacin hydrochloride; fluocinolone acetonide SOLUTION/DROPS;OTIC 208251-001 Apr 29, 2016 RX Yes Yes   Start Trial   Start Trial   Start 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 13C0012 France   Start 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 122012000070 Germany   Start 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 SPC/GB12/058 United Kingdom   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
McKesson
Mallinckrodt
Colorcon
Merck
AstraZeneca

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 verifification 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.