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Last Updated: March 29, 2024

Ciprofloxacin; dexamethasone - Generic Drug Details


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What are the generic sources for ciprofloxacin; dexamethasone and what is the scope of freedom to operate?

Ciprofloxacin; dexamethasone is the generic ingredient in two branded drugs marketed by Sandoz, Dr Reddys, Sentiss, and Sun Pharm, and is included in four NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ciprofloxacin; dexamethasone has nineteen patent family members in sixteen countries.

Eight suppliers are listed for this compound.

Summary for ciprofloxacin; dexamethasone
Recent Clinical Trials for ciprofloxacin; dexamethasone

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

SponsorPhase
University of Campinas, BrazilPhase 2
St. Paul's Hospital, CanadaPhase 4
National University of MalaysiaPhase 1/Phase 2

See all ciprofloxacin; dexamethasone clinical trials

Paragraph IV (Patent) Challenges for CIPROFLOXACIN; DEXAMETHASONE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CIPRODEX Otic Suspension ciprofloxacin; dexamethasone 0.3%/0.1% 021537 1 2012-07-31

US Patents and Regulatory Information for ciprofloxacin; dexamethasone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sun Pharm CIPROFLOXACIN AND DEXAMETHASONE ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 210470-001 Aug 30, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys CIPROFLOXACIN AND DEXAMETHASONE ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 205548-001 Aug 10, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sentiss CIPROFLOXACIN AND DEXAMETHASONE ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 215768-001 Jun 9, 2023 AB RX No 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 ciprofloxacin; dexamethasone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sandoz CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 ⤷  Try a Trial ⤷  Try a Trial
Sandoz CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 ⤷  Try a Trial ⤷  Try a Trial
Sandoz CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 ⤷  Try a Trial ⤷  Try a Trial
Sandoz CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 ⤷  Try a Trial ⤷  Try a Trial
Sandoz CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 ⤷  Try a Trial ⤷  Try a Trial
Sandoz CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ciprofloxacin; dexamethasone

Country Patent Number Title Estimated Expiration
Japan 2005504804 ⤷  Try a Trial
Russian Federation 2004111984 ⤷  Try a Trial
European Patent Office 1429780 PROCEDE DE TRAITEMENT DE L'INFECTION DE L'OREILLE MOYENNE (METHOD OF TREATING MIDDLE EAR INFECTIONS) ⤷  Try a Trial
Austria 313328 ⤷  Try a Trial
South Korea 20040035760 ⤷  Try a Trial
Germany 60208216 ⤷  Try a Trial
China 1231218 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ciprofloxacin; dexamethasone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1429780 CA 2012 00045 Denmark ⤷  Try a Trial
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
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 132013902137451 Italy ⤷  Try a Trial PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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