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Last Updated: May 16, 2021

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CIPRODEX Drug Profile

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Which patents cover Ciprodex, and when can generic versions of Ciprodex launch?

Ciprodex is a drug marketed by Novartis and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has nineteen patent family members in sixteen countries.

The generic ingredient in CIPRODEX is ciprofloxacin; dexamethasone. There are thirty-four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.

Drug patent expirations by year for CIPRODEX
Drug Prices for CIPRODEX

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Drug Sales Revenue Trends for CIPRODEX

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Recent Clinical Trials for CIPRODEX

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

SponsorPhase
Boston Medical CenterPhase 4
St. Paul's Hospital, CanadaPhase 4
Exela Pharma Sciences, LLC.Phase 3

See all CIPRODEX clinical trials

Pharmacology for CIPRODEX
Paragraph IV (Patent) Challenges for CIPRODEX
Tradename Dosage Ingredient NDA Submissiondate
CIPRODEX SUSPENSION/DROPS;OTIC ciprofloxacin; dexamethasone 021537 2012-07-31

US Patents and Regulatory Information for CIPRODEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 AB RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Novartis CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 AB RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Novartis CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 AB RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Novartis CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 AB RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
>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 CIPRODEX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003   Get Started for $10   Get Started for $10
Novartis CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003   Get Started for $10   Get Started for $10
Novartis CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for CIPRODEX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1429780 132013902137451 Italy   Get Started for $10 PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
1429780 122012000070 Germany   Get Started for $10 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   Get Started for $10 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   Get Started for $10 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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