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Last Updated: October 7, 2024

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CIPRODEX Drug Patent Profile


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

Ciprodex is a drug marketed by Sandoz and is included in one NDA. There is one patent 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. Ten suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.

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

See all CIPRODEX clinical trials

Paragraph IV (Patent) Challenges for CIPRODEX
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 CIPRODEX

CIPRODEX is protected by one US patents.

Patents protecting CIPRODEX

Method of treating middle ear infections
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE OTITIS MEDIA

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

International Patents for CIPRODEX

See the table below for patents covering CIPRODEX around the world.

Country Patent Number Title Estimated Expiration
China 1376054 ⤷  Sign Up
Spain 2250739 ⤷  Sign Up
European Patent Office 1429780 PROCEDE DE TRAITEMENT DE L'INFECTION DE L'OREILLE MOYENNE (METHOD OF TREATING MIDDLE EAR INFECTIONS) ⤷  Sign Up
Japan S63203629 LOCALLY APPLICABLE BLEND OF DILASE INHIBITOR COMBINED WITH CORTICOSTEROIDS ⤷  Sign Up
China 1158994 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CIPRODEX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1429780 122012000070 Germany ⤷  Sign Up 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 CA 2012 00045 Denmark ⤷  Sign Up
1429780 SPC/GB12/058 United Kingdom ⤷  Sign Up 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 13C0012 France ⤷  Sign Up 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 ⤷  Sign Up PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.