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CIPRO Drug Profile

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

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:7
Applicants:41
NDAs:55
Suppliers / Packagers: see list1

Pharmacology for Tradename: CIPRO

Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial

Clinical Trials for: CIPRO

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Idt Australia Ltd
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL075939-001Mar 3, 2005DISCNNo<disabled><disabled>
Dr Reddys Labs Ltd
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL075593-004Jun 9, 2004RXNo<disabled><disabled>
Sandoz
CIPROFLOXACIN EXTENDED RELEASE
ciprofloxacin; ciprofloxacin hydrochloride
TABLET, EXTENDED RELEASE;ORAL078712-001Dec 11, 2007DISCNNo<disabled><disabled>
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Expired Patents for Tradename: CIPRO

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
CIPRO
ciprofloxacin
FOR SUSPENSION;ORAL020780-002Sep 26, 19976,136,347*PED<disabled>
Bayer Hlthcare
CIPRO
ciprofloxacin hydrochloride
TABLET;ORAL019537-004Oct 22, 19874,670,444*PED<disabled>
Bayer Hlthcare
CIPRO
ciprofloxacin hydrochloride
TABLET;ORAL019537-001Apr 8, 19965,286,754*PED<disabled>
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Paragraph IV activity for: CIPRO

Drugname Dosage Strength RLD Submissiondate
ciprofloxacin and dexamethasoneOtic Suspension0.3%/0.1%Ciprodex7/31/2012
ciprofloxacinOral Suspension250 mg/5 mL and 500 mg/ 5 mLCipro10/16/2009
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