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

International Patents:	43
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	34
Suppliers / Packagers:	2
Clinical Trials:	14
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CIPROFLOXACIN; DEXAMETHASONE
DailyMed Link:	CIPROFLOXACIN; DEXAMETHASONE at DailyMed

Recent Clinical Trials for CIPROFLOXACIN; DEXAMETHASONE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Santen Pharmaceutical Co., Ltd.	Phase 1/Phase 2
National University of Malaysia	Phase 1/Phase 2
Haining Health-Coming Biotech Co., Ltd.	Phase 2

See all CIPROFLOXACIN; DEXAMETHASONE clinical trials

Pharmacology for CIPROFLOXACIN; DEXAMETHASONE

Drug Class	Quinolone Antimicrobial Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

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

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Glossary

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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

Expired US Patents for CIPROFLOXACIN; DEXAMETHASONE

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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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for CIPROFLOXACIN; DEXAMETHASONE

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Country	Patent Number	Estimated Expiration
Denmark	1214056	Start Trial
China	1555267	Start Trial
Spain	2207549	Start Trial
Russian Federation	2295346	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for CIPROFLOXACIN; DEXAMETHASONE

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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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