You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 19, 2024

Ciprofloxacin; dexamethasone - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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.

Nine 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
University of Campinas, BrazilPhase 2
St. Paul's Hospital, CanadaPhase 4
Santen Pharmaceutical Co., Ltd.Phase 1/Phase 2

See all ciprofloxacin; dexamethasone clinical trials

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm CIPROFLOXACIN AND DEXAMETHASONE ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 210470-001 Aug 30, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
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
>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

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

Country Patent Number Title Estimated Expiration
Canada 2459930 PROCEDE DE TRAITEMENT DE L'INFECTION DE L'OREILLE MOYENNE (METHOD OF TREATING MIDDLE EAR INFECTIONS) ⤷  Sign Up
South Africa 200401847 METHOD OF TREATING MIDDLE EAR INFECTIONS ⤷  Sign Up
World Intellectual Property Organization (WIPO) 03026671 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ciprofloxacin; dexamethasone

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1429780 122012000070 Germany ⤷  Sign Up 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 ⤷  Sign Up
1429780 132013902137451 Italy ⤷  Sign Up 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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.