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Last Updated: September 22, 2020

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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 six patents protecting this drug and one Paragraph IV challenge.

This drug has forty-three patent family members in twenty-two 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.

US ANDA Litigation and Generic Entry Outlook for Ciprodex

Annual sales in 2018 were $174mm indicating the motivation for generic entry (peak sales were $195mm in 2017).

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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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   Start Trial   Start Trial Y   Start Trial
Novartis CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novartis CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 AB RX Yes Yes   Start Trial   Start Trial Y   Start 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 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   Start Trial   Start Trial
Novartis CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003   Start Trial   Start Trial
Novartis CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003   Start Trial   Start Trial
>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 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 132013902137451 Italy   Start Trial PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
1429780 CA 2012 00045 Denmark   Start Trial
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKesson
Colorcon
Mallinckrodt
Baxter
Moodys

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.