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Last Updated: August 8, 2020

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CIPROFLOXACIN; DEXAMETHASONE - Generic Drug Details

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What are the generic drug sources for ciprofloxacin; dexamethasone and what is the scope of patent protection?

Ciprofloxacin; dexamethasone is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ciprofloxacin; dexamethasone has forty-three patent family members in twenty-two countries.

There are thirty-four drug master file entries for ciprofloxacin; dexamethasone. Two 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
Santen Pharmaceutical Co., Ltd.Phase 1/Phase 2
National University of MalaysiaPhase 1/Phase 2
Haining Health-Coming Biotech Co., Ltd.Phase 2

See all CIPROFLOXACIN; DEXAMETHASONE clinical trials

Pharmacology for CIPROFLOXACIN; DEXAMETHASONE
Paragraph IV (Patent) Challenges for CIPROFLOXACIN; DEXAMETHASONE
Tradename Dosage Ingredient NDA Submissiondate
CIPRODEX SUSPENSION/DROPS;OTIC ciprofloxacin; dexamethasone 021537 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
Novartis CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novartis CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novartis CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 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

Supplementary Protection Certificates for CIPROFLOXACIN; DEXAMETHASONE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
1429780 132013902137451 Italy   Start Trial 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Dow
Express Scripts
McKinsey
Harvard Business School
McKesson

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