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Profile for Tradename: CIPRO

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Cipro is a drug marketed by Bayer Hlthcare, Alcon Pharms Ltd, Bayer Pharms, Lupin Ltd, Bedford Labs, Claris Lifesciences, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Teva Pharms Usa, Actavis Labs Fl Inc, Anchen Pharms, Dr Reddys Labs Ltd, Mylan Pharms Inc, Sandoz, Akorn Inc, Apotex Inc, Fdc Ltd, Igi Labs Inc, Nexus Pharms, Pharmaforce, Watson Labs Inc, Apotex, Aurobindo Pharma, Barr, Carlsbad, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Ranbaxy, Taro, Teva, Unique Pharm Labs, Watson Labs, Acs Dobfar Info Sa, Baxter Hlthcare, Bedford, and Teva Pharms. and is included in fifty-five NDAs. It is available from one supplier. There are nine patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in CIPRO is ciprofloxacin; dexamethasone. There are thirty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.

Summary for Tradename: CIPRO

Patents:9
Applicants:40
NDAs:55
Suppliers: see list1

Pharmacology for Tradename: CIPRO

Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial

Clinical Trials for: CIPRO

Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) in Patients With Cystic Fibrosis
Status: Completed Condition: Cystic Fibrosis

Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis
Status: Completed Condition: Bronchiectasis

Safety and Efficacy of Once-Daily Dosing of FoamOtic Cipro Compared to Twice-Daily Dosing of Ciloxan Ear Drops in Patients With Acute External Otitis
Status: Completed Condition: Otitis Externa; Otorhinolaryngologic Diseases; Ear Diseases; Otitis

Safety and Efficacy Study of Foam Otic Cipro Compared to a Standard Solution ( Ciloxan - Alcon Labs ) to Treat Acute Otitis Externa
Status: Completed Condition: Otitis Externa; Otorhinolaryngologic Diseases; Ear Diseases; Otitis

Impact of Formulation on Ciprofloxacin Oral Absorption
Status: Completed Condition: Healthy

Drug - Drug Interaction Study of Quinine Sulfate and Ciprofloxacin
Status: Completed Condition: Healthy

A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension
Status: Not yet recruiting Condition: Otitis Externa

Ciprofloxacin for Prevention of BK Infection
Status: Recruiting Condition: BK Virus Infection

Ciprofloxacin XR Drug Interaction Study With MMX® Mesalazine/Mesalamine
Status: Completed Condition: Healthy

Study to Characterize Lung Deposition, Pharmacokinetics, Safety and Tolerability of Single Inhalations of Radiolabeled Ciprofloxacin Dry Powder in Healthy Subjects and Patients With Chronic Lung Diseases
Status: Completed Condition: Respiratory System

Ciprofloxacin for the Prevention of Postoperative Endoscopic Recurrence in Crohn's Disease
Status: Completed Condition: Crohn's Disease

Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD)
Status: Completed Condition: Disease, Pulmonary

Study To Evaluate The Efficacy And Safety Of Ciprofloxacin Extended-Release (Cipro® XR) 1000 mg Tablets Given Once Daily For 7 To 14 Days In The Treatment Of Patients 18 Years Or Older With Complicated Urinary Tract Infections Caused By Pseudomonas Aeruginosa And Other Common Uropathogens
Status: Completed Condition: Urinary Tract Infections

Ciprofloxacin BioThrax Co-Administration Study
Status: Completed Condition: Anthrax

Cipro Inhaler for Cystic Fibrosis Children Ages 6-12
Status: Completed Condition: Pseudomonas Infection

Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Status: Completed Condition: Pulmonary Disease, Chronic Obstructive

A Phase IV Study of Cipro XR in Uncomplicated UTI
Status: Completed Condition: Urinary Tract Infections

Ciprofloxacin Compared to Placebo in Diagnosing Prostate Cancer in Patients Undergoing Prostate Biopsy
Status: Not yet recruiting Condition: Prostate Cancer

Cipro® XR in Therapeutic Response and Activity (eXtRa) - Assessing Symptom Relief in Urinary Tract Infections
Status: Completed Condition: Urinary Tract Infection

Ciprofloxacin on Burned Patients
Status: Completed Condition: Burns; Bacterial Infections

Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
Status: Recruiting Condition: Bronchiectasis

Comparison of Infection and Urosepsis Rates During Retrograde Intrarenal Surgery After Multiple-, Single-, Zero-dose of Ciprofloxacin Prophylaxis
Status: Recruiting Condition: Kidney Stones

Ph1 Study of Valortim and Ciprofloxacin in Humans
Status: Suspended Condition: Anthrax

An Open-Label, Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Multiple-Dose Ciprofloxacin on Ivacaftor and VX-661 in Combination With Ivacaftor
Status: Completed Condition: Cystic Fibrosis

Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
Status: Recruiting Condition: Bronchiectasis

Study of Antibiotics in the Treatment of Colonic Crohn's Disease
Status: Terminated Condition: Crohn's Disease

Ciprofloxacin Multiple Dose for Adult Cholera
Status: Completed Condition: Cholera

Study in COPD (Chronic Obstructive Pulmonary Disease) Subjects to Investigate Safety, Tolerability, and Pharmacokinetics of Ciprofloxacin After Single Dose Inhalations of 50 mg and 75 mg Ciprofloxacin Inhalation Powder
Status: Completed Condition: Infection; Pulmonary Disease, Chronic Obstructive

Population Pharmacokinetics of Anti-infectious Drugs in Children
Status: Recruiting Condition: Pediatrics; Ceftazidime; Ciprofloxacin; Voriconazole

Cefpodoxime vs Ciprofloxacin for Acute Cystitis
Status: Completed Condition: Urinary Tract Infection

Norfloxacin Versus Ciprofloxacin for Spontaneous Bacterial Peritonitis (SBP) Prevention
Status: Recruiting Condition: Adverse Reaction to Other Drugs and Medicines

Sub-Tenon's Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System for Cataract Surgery
Status: Terminated Condition: Inflammation; Bacterial Infections

Food Study of Ciprofloxacin Extended-Release Tablets 1000 mg and Cipro® XR Tablets 1000 mg
Status: Completed Condition: Healthy

Fasting Study of Ciprofloxacin Extended-Release Tablets 500 mg and Cipro® XR Tablets 500 mg
Status: Completed Condition: Healthy

Fasting Study of Ciprofloxacin Extended-Release Tablets 1000 mg and Cipro® XR Tablets 1000 mg
Status: Completed Condition: Healthy

Adalimumab in Combination With Ciprofloxacin/Placebo Treatment of Perianal Fistulas in Crohn's
Status: Completed Condition: Crohn's Disease With Perianal Fistulas

TINN Pharmacokinetics (PK) Study Treat Infections iN Neonates
Status: Recruiting Condition: Pharmacokinetics of Ciprofloxacin in Neonates

Evaluate the Effects of Itraconazole and Ciprofloxacin on Single-Dose PK of Pracinostat in Healthy Nonsmoking Subjects
Status: Active, not recruiting Condition: Healthy Volunteers; Non-smokers

Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis "ORBIT-1"
Status: Completed Condition: Non-Cystic Fibrosis Bronchiectasis

S9809, Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer
Status: Terminated Condition: Bladder Cancer

Efficacy and Safety of CIPRO XR Versus CIPRO IR in Patients With Complicated Urinary Tract Infections
Status: Completed Condition: Urinary Tract Infection

Efficacy Study of Prophylaxis With Fosfomycin Versus Ciprofloxacin Prior Prostate Biopsy
Status: Recruiting Condition: Urinary Tract Infections

A Clinical Trial to Evaluate the Safety and Efficacy of Ciprofloxacin in the Treatment of Plague in Humans
Status: Recruiting Condition: Plague

Comparison of Moxifloxacin With Ciprofloxacin/Metronidazole on Patients With Chronic Periodontitis
Status: Completed Condition: Chronic Periodontitis

To Evaluate the Safety, Tolerability, Pulmonary Deposition, Pharmacokinetics and Pharmacodynamics of Ciprofloxacin Inhale in Japanese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD, GOLD II-III)
Status: Completed Condition: Pulmonary Disease, Chronic Obstructive

BAY 0 9867 Cipro Pediatric Use Study (QUIP)
Status: Completed Condition: Infectious Diseases

Open-Label, Randomized, Parallel Group Study to Assess the Safety, Tolerability and PK of ETI-204 Alone and in Presence of Ciprofloxacin in Adult Volunteers
Status: Completed Condition: Inhalational Anthrax

A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects
Status: Completed Condition: Cystic Fibrosis

Finafloxacin 300 mg Twice a Day (b.i.d.) Versus Ciprofloxacin 250 mg Twice a Day (b.i.d) in Patients With Lower Uncomplicated UTI (uUTI)
Status: Completed Condition: Urinary Tract Infections

Randomized Trial of Ciprofloxacin Versus Observation for Men With Elevated Prostate Specific Antigen (PSA)
Status: Terminated Condition: Elevated Prostate Specific Antigen

Trial to Evaluate the Efficacy and Safety of Cipro® XR in Treating Female Patients With Lower Urinary Tract Infections
Status: Completed Condition: Urinary Tract Infection

A Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults
Status: Terminated Condition: Diverticular Sigmoïditis

Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial
Status: Completed Condition: Cholera

Parameters Associated With the Emergence of Resistance to Ciprofloxacin in Human Commensal Flora
Status: Terminated Condition: Healthy Volunteers

Safety and Efficacy Study of Gatifloxacin Compared With Ciprofloxacin in Patients With Acute Bacterial Corneal Ulcers
Status: Completed Condition: Acute Bacterial Corneal Ulcers; Bacterial Keratitis

A Phase II/III Trial of Rifampin, Ciprofloxacin, Clofazimine, Ethambutol, and Amikacin in the Treatment of Disseminated Mycobacterium Avium Infection in HIV-Infected Individuals.
Status: Completed Condition: Mycobacterium Avium-intracellulare Infection; HIV Infections

Bioavailability Study of Ciprofloxacin 1000 mg ER Tablets of Dr. Reddy's Under Fasting Conditions
Status: Completed Condition: Fasting

Bioavailability Study of Ciprofloxacin 1000 mg ER Tablets of Dr. Reddy's Under Non-Fasting Conditions
Status: Completed Condition: Fed

Bioequivalence of Two Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspensions in Otitis Media in Children With Tympanostomy Tubes
Status: Recruiting Condition: Otitis Media in Patients With Tympanostomy Tubes.

Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli Nissle
Status: Completed Condition: Ulcerative Colitis

Ciprofloxacin Special Drug Use Investigation - To Investigate the Safety and Efficacy in Patients With Ciprofloxacin iv Administration Without Dilution
Status: Completed Condition: Infection

Study In Healthy Subjects To Evaluate The Photo-Irritant Potential Of Eltrombopag
Status: Completed Condition: Healthy Subjects; Purpura, Thrombocytopenic, Idiopathic

Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis
Status: Completed Condition: Cystic Fibrosis; Pulmonary Disease, Chronic Obstructive

REaCT Integrated Consent Model to Compare Two Standard of Care Regimens
Status: Not yet recruiting Condition: Breast Cancer

Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis
Status: Completed Condition: Cystic Fibrosis

Phase 3 Study With Dual Release Ciprofloxacin for Inhalation in Non-CF Bronchiectasis
Status: Recruiting Condition: Non Cystic Fibrosis Bronchiectasis

BK Virus in Salivary Gland Disease: Treating the Potential Etiologic Agent
Status: Recruiting Condition: HIV; Salivary Gland Disease; Benign Lymphoepithelial Lesion

A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa
Status: Recruiting Condition: Otitis Externa

Bacterial Resistance in Patients Receiving Post-Intravitreal Injection Antibiotics
Status: Not yet recruiting Condition: Bacterial Resistance

Comparative Efficacy and Safety of Two Ciprofloxacin 0.3% and Dexamethasone 0.1% Formulations in Subjects With Acute Otitis Externa
Status: Recruiting Condition: Acute Otitis Externa

Moxifloxacin Compared With Ciprofloxacin/Amoxicillin in Treating Fever and Neutropenia in Patients With Cancer
Status: Terminated Condition: Chronic Myeloproliferative Disorders; Fever, Sweats, and Hot Flashes; Infection; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Neutropenia; Precancerous Condition; Unspecified Adult Solid Tumor, Protocol Specific

Antibiotics and Hydroxychloroquine in Crohn's
Status: Recruiting Condition: Crohn's Disease

Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases
Status: Recruiting Condition: Febrile Neutropenia

Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea
Status: Recruiting Condition: Traveler's Diarrhea

Comparison of Efficacy of Cefotaxime, Ceftriaxone, and Ciprofloxacin for the Treatment of Spontaneous Bacterial Peritonitis in Patients With Liver Cirrhosis
Status: Recruiting Condition: SBP; Liver Cirrhosis

Antibiotic Prophylaxis in Laparoscopic Cholecystectomy
Status: Recruiting Condition: Cholelithiasis

Efficacy and Safety of Cefditoren Pivoxil Versus Ciprofloxacin in Acute Uncomplicated Cystitis
Status: Completed Condition: Urinary Tract Infections

Meropenem and Ciprofloxacin Dosing in Septic Shock
Status: Not yet recruiting Condition: Septic Shock

Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy
Status: Recruiting Condition: Prostate Cancer; Urinary Tract Infection; Clostridium Difficile

Clarithromycin v Ciprofloxacin Added to Rifampicin + Ethambutol, for Opportunist Mycobacterial Pulmonary Disease
Status: Completed Condition: Pulmonary Diseases

Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients
Status: Withdrawn Condition: Cirrhosis; Ascites; Infections

Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis
Status: Recruiting Condition: Urinary Tract Infections; Acute Pyelonephritis

BAYQ3939, 1000 mg Tablet in Transrectal Needle Biopsies of the Prostate (TRNBP) - Infection Prophylaxis
Status: Completed Condition: Bacterial Infections

A Study to Evaluate the Safety and Effectiveness of Levofloxacin Compared With Ciprofloxacin in Patients With Chronic Bacterial Prostatitis
Status: Completed Condition: Prostatitis

Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa
Status: Completed Condition: Otitis Externa; Otorhinolaryngologic Diseases; Ear Diseases; Otitis

TMC435-TiDP16-C125 - Study in Healthy Volunteers to Evaluate the Potential of TMC435 to Increase the Sensitivity of the Skin Towards Exposure to Sun Light
Status: Completed Condition: Hepatitis C Virus

Trimethoprim-Sulfamethoxazole Versus Ciprofloxacin in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) Requiring Mechanical Ventilation
Status: Completed Condition: Chronic Obstructive Pulmonary Disease; Sepsis; Antibiotics

A Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics/Pharmacodynamics of BAYQ3939 in Patients With Bacterial Pneumonia
Status: Recruiting Condition: Pneumonia

Antibiotic Prophylaxis for Transrectal Prostate Biopsy
Status: Recruiting Condition: Infection

A Pilot Study on the Use of Prophylactic Antibiotics for EUS-guided Pancreatic Cyst Aspiration
Status: Recruiting Condition: Pancreatic Cysts

Targeted Retreatment of COPD Exacerbations
Status: Recruiting Condition: Chronic Obstructive Pulmonary Disease (COPD)

An Observational Study of Oral Fluoroquinolones and the Risk of Retinal Detachment
Status: Completed Condition: Retinal Detachment

Efficacy of Antimicrobial Prophylaxis for Shock Wave Lithotripsy (SWL) on Reducing Urinary Tract Infection (UTI)
Status: Enrolling by invitation Condition: Urolithiasis

Safety and Efficacy of Gentamicin Topical Gel (AppliGel-G) for Treatment of Mild to Moderately Infected Diabetic Foot Ulcers
Status: Recruiting Condition: Diabetic Foot Ulcers

Impact of Antibiotic Treatment on Prostate-Specific Antigen (PSA) Variability
Status: Terminated Condition: Prostate Infections

Longitudinal Study of the Human Intestinal Microbiome
Status: Completed Condition: Intestinal Microbiome

Monoclonal Antibody for Treatment of Inhalation Anthrax
Status: Completed Condition: Bacillus Anthracis (Anthrax)

Evaluation of Ciprofloxacin for Inhalation to Cystic Fibrosis Patients With P. Aeruginosa
Status: Withdrawn Condition: Cystic Fibrosis

A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Complicated Urinary Tract Infections
Status: Completed Condition: Urinary Tract Infections; Bacteriuria; Urologic Diseases; Pyelonephritis; Neurogenic Bladder

Pharmacokinetic Study to Characterize Phenotyping Metrics of the "Basel" Cocktail After CYP Induction or Inhibition
Status: Completed Condition: Metabolic Detoxication, Phase I

Courtesy of ClinicalTrials.org
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Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL076896Nov 4, 2004RXNo<disabled><disabled>
Aurobindo Pharma
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL077859Apr 26, 2007RXNo<disabled><disabled>
Watson Labs
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL076794Jun 9, 2004RXNo<disabled><disabled>
Sandoz
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL075939Jun 9, 2004DISCNNo<disabled><disabled>
Taro
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL076912Oct 6, 2004RXNo<disabled><disabled>
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Paragraph IV activity for: CIPRO

Drugname Dosage Strength RLD Submissiondate
ciprofloxacinOral Suspension250 mg/5 mL and 500 mg/ 5 mLCipro10/16/2009
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Preferred citation: Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).
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