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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. Nine suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ciprodex

A generic version of CIPRODEX was approved as ciprofloxacin; dexamethasone by DR REDDYS on August 10^th, 2020.

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Summary for CIPRODEX

International Patents:	19
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	10
Patent Applications:	60
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CIPRODEX
Drug Sales Revenues:	Drug sales revenues for CIPRODEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CIPRODEX
What excipients (inactive ingredients) are in CIPRODEX?	CIPRODEX excipients list
DailyMed Link:	CIPRODEX at DailyMed

Drug patent expirations by year for CIPRODEX

Recent Clinical Trials for CIPRODEX

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

Sponsor	Phase
St. Paul's Hospital, Canada	Phase 4
Boston Medical Center	Phase 4
Exela Pharma Sciences, LLC.	Phase 3

See all CIPRODEX clinical trials

Pharmacology for CIPRODEX

Drug Class	Corticosteroid Fluoroquinolone Antibacterial Quinolone Antimicrobial
Mechanism of Action	Corticosteroid Hormone Receptor Agonists Cytochrome P450 1A2 Inhibitors

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

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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
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

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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
>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.

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Country	Patent Number	Title	Estimated Expiration
Argentina	025661	FORMULACIONES EN SUSPENSION TOPICA CON CONTENIDO DE CIPROFLOXACINA Y DEXAMETASONA	⤷ Sign Up
Poland	201130		⤷ Sign Up
Brazil	0212898		⤷ Sign Up
Australia	776609		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CIPRODEX

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1429780	132013902137451	Italy	⤷ Sign Up	PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description