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Details for Generic Name: ciprofloxacin

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Ciprofloxacin is the generic ingredient in fifteen branded drugs marketed by Bayer Hlthcare, Lupin Ltd, Otonomy Inc, Bayer Pharms, Bedford Labs, Claris Pharmaservice, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Teva Pharms Usa, Acs Dobfar Info Sa, Baxter Hlthcare, Bedford, Teva Pharms, Alcon Pharms Ltd, Akorn Inc, Apotex Inc, Fdc Ltd, Igi Labs Inc, Pharmaforce, Rising Pharms Inc, Watson Labs Inc, Wraser Pharms, Depomed Inc, Apotex, Aurobindo Pharma, Barr, Carlsbad, Dr Reddys Labs Ltd, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sandoz, Sun Pharm Inds Ltd, Taro, Teva, Unique Pharm Labs, Watson Labs, Actavis Labs Fl Inc, Anchen Pharms, and Mylan Pharms Inc, and is included in sixty NDAs. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and two patent family members in seventeen countries.

There are thirty drug master file entries for ciprofloxacin. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: ciprofloxacin

Drug Master File Entries: see list30
Suppliers / Packaging: see list3
Therapeutic Class:Antibacterials

Pharmacology for Ingredient: ciprofloxacin

Drug ClassQuinolone Antimicrobial

Tentative approvals for CIPROFLOXACIN

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL100MG
<disabled><disabled>Tablet; Oral100MG

Clinical Trials for: ciprofloxacin

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

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

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

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

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

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

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
INJECTABLE;INJECTION077245-001Aug 28, 2006RXNo<disabled><disabled>
ciprofloxacin hydrochloride
TABLET;ORAL076126-002Jun 9, 2004RXNo<disabled><disabled>
Bedford Labs
INJECTABLE;INJECTION076992-001Aug 28, 2006DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: ciprofloxacin

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Pharms
INJECTABLE;INJECTION019858-001Dec 26, 19904,957,922*PED<disabled>
Bayer Hlthcare
FOR SUSPENSION;ORAL020780-001Sep 26, 19974,670,444*PED<disabled>
Bayer Hlthcare
INJECTABLE;INJECTION019847-001Dec 26, 19904,705,789*PED<disabled>
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International Patent Family for Ingredient: ciprofloxacin

Country Document Number Publication Date
Japan2012513394Jun 14, 2012
Mexico2011000545Feb 24, 2011
European Patent Office2299979Mar 30, 2011
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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