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 three branded drugs marketed by Sandoz, Dr Reddys, Sentiss, Sun Pharm, and Amneal, and is included in five NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ciprofloxacin; dexamethasone has nineteen patent family members in sixteen countries.

Ten suppliers are listed for this compound.

Summary for CIPROFLOXACIN; DEXAMETHASONE

International Patents:	19
US Patents:	1
Tradenames:	3
Applicants:	5
NDAs:	5
Finished Product Suppliers / Packagers:	10
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
University of Campinas, Brazil	Phase 2
St. Paul's Hospital, Canada	Phase 4
Santen Pharmaceutical Co., Ltd.	Phase 1/Phase 2

See all CIPROFLOXACIN; DEXAMETHASONE clinical trials

Pharmacology for CIPROFLOXACIN; DEXAMETHASONE

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

Anatomical Therapeutic Chemical (ATC) Classes for CIPROFLOXACIN; DEXAMETHASONE

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 CIPROFLOXACIN; DEXAMETHASONE

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 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
Sandoz	CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537-001	Jul 18, 2003	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Amneal	CIPROFLOXACIN; DEXAMETHASONE	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	216501-001	Mar 22, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sentiss	CIPROFLOXACIN AND DEXAMETHASONE	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	215768-001	Jun 9, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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 CIPROFLOXACIN; DEXAMETHASONE

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

International Patents for CIPROFLOXACIN; DEXAMETHASONE

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Country	Patent Number	Title	Estimated Expiration
Spain	2250739		⤷ Sign Up
South Korea	20040035760		⤷ Sign Up
Mexico	PA04002576	METODO PARA TRATAR INFECCIONES DEL OIDO MEDIO. (METHOD OF TREATING MIDDLE EAR INFECTIONS.)	⤷ Sign Up
>Country	>Patent Number	>Title	>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	⤷ Sign Up
1429780	132013902137451	Italy	⤷ Sign Up	PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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