Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

McKesson
Harvard Business School
AstraZeneca
Dow
Medtronic
Moodys

Last Updated: December 15, 2019

DrugPatentWatch Database Preview

CIPROFLOXACIN; DEXAMETHASONE - Generic Drug Details

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What are the generic sources for ciprofloxacin; dexamethasone and what is the scope of freedom to operate?

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. Three 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
Haining Health-Coming Biotech Co., Ltd.Phase 2
St. Paul's Hospital, CanadaPhase 4
Spectrum Pharmaceuticals, IncPhase 1

See all CIPROFLOXACIN; DEXAMETHASONE clinical trials

Recent Litigation for CIPROFLOXACIN; DEXAMETHASONE

Identify potential future generic entrants

District Court Litigation
Case NameDate
ALCON PHARMACEUTICALS LTD. v. DR. REDDYS LABORATORIES, INC.2015-07-24
Baker v. Bayer Aktiengescellschaft Corporation2010-04-13
Alcon Pharmaceuticals v. Teva Pharmaceuticals2009-12-02

See all CIPROFLOXACIN; DEXAMETHASONE litigation

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
>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 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Boehringer Ingelheim
McKesson
AstraZeneca
Johnson and Johnson
McKinsey

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