CIPRODEX Drug Patent Profile

Which patents cover Ciprodex, and when can generic versions of Ciprodex launch?

Ciprodex is a drug marketed by Novartis 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. Seven 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.

Summary for CIPRODEX

International Patents:	19
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	10
Patent Applications:	80
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

See drug prices for CIPRODEX

See drug sales revenues 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

Anatomical Therapeutic Chemical (ATC) Classes for CIPRODEX

A01AC	Corticosteroids for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

C05AA	Corticosteroids
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D07AB	Corticosteroids, moderately potent (group II)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XB	Corticosteroids, moderately potent, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D10AA	Corticosteroids, combinations for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

H02AB	Glucocorticoids
H02A	CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

J01MA	Fluoroquinolones
J01M	QUINOLONE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J01MA	Fluoroquinolones
J01M	QUINOLONE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01CB	Corticosteroids/antiinfectives/mydriatics in combination
S01C	ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S02BA	Corticosteroids
S02B	CORTICOSTEROIDS
S02	OTOLOGICALS
S	Sensory organs

S03AA	Antiinfectives
S03A	ANTIINFECTIVES
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

S03BA	Corticosteroids
S03B	CORTICOSTEROIDS
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

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

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	AB	RX	Yes	Yes			Y

Expired US Patents for CIPRODEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537-001	Jul 18, 2003
Novartis	CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537-001	Jul 18, 2003
Novartis	CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537-001	Jul 18, 2003
Novartis	CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537-001	Jul 18, 2003
Novartis	CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537-001	Jul 18, 2003

International Patents for CIPRODEX

See the table below for patents covering CIPRODEX around the world.

Country	Patent Number	Title	Estimated Expiration
China	1158994
Mexico	PA02003130	FORMULACIONES TOPICAS EN SUSPENSION QUE CONTIENEN CIPROFLOXACINO Y DEXAMETASONA. (TOPICAL SUSPENSION FORMULATIONS CONTAINING CIPROFLOXACIN AND DEXAMETHASONE.)
Taiwan	I228423
South Africa	200401847	METHOD OF TREATING MIDDLE EAR INFECTIONS
Japan	2003510263

Supplementary Protection Certificates for CIPRODEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1429780	13C0012	France		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
1429780	SPC/GB12/058	United Kingdom		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	122012000070	Germany		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	CA 2012 00045	Denmark
1429780	132013902137451	Italy		PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106