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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Fish and Richardson
Covington
Teva
Citi
Cerilliant
Julphar
Fuji
McKesson

Generated: July 22, 2018

DrugPatentWatch Database Preview

CIPRODEX Drug Profile

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When do Ciprodex patents expire, and what generic alternatives are available?

Ciprodex is a drug marketed by Novartis Pharms Corp 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-one 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
Generic Entry Opportunity Date for CIPRODEX
Generic Entry Date for CIPRODEX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
SUSPENSION/DROPS;OTIC

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for CIPRODEX
Synonyms for CIPRODEX
130244-48-3
Ciprodex Otic
Ciprofloxacin / dexamethasone
Ciprofloxacin and dexamethasone
Ciprofloxacin mixture with dexamethasone
Ciprofloxacin-dexamethasone Mixt.
Ciprofloxacin+dexamethasone
D03KPZ
DTXSID50156420
NTRHYMXQWWPZDD-WKSAPEMMSA-N
Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11beta,16alpha)-, mixt. with 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid
SCHEMBL2523572

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 Pharms Corp CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis Pharms Corp CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis Pharms Corp CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for CIPRODEX
Drugname Dosage Strength RLD Date
➤ Subscribe Otic Suspension 0.3%/0.1% ➤ Subscribe ➤ Try a Free Trial

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Supplementary Protection Certificates for CIPRODEX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB12/058 United Kingdom ➤ Try a Free 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
C0012 France ➤ Try a Free 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
2012 00045 Denmark ➤ Try a Free Trial
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
US Department of Justice
Moodys
Farmers Insurance
McKinsey
Chubb
Chinese Patent Office
Dow
Julphar

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