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Ciprofloxacin - Generic Drug Details

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Ciprofloxacin is the generic ingredient in sixteen branded drugs marketed by Bedford, Hikma Farmaceutica, Claris, Teva Pharms, Hospira, Bayer Hlthcare, Acs Dobfar Info Sa, Bayer Pharms, Lupin Ltd, Teva Pharms Usa, Fresenius Kabi Usa, Otonomy Inc, Baxter Hlthcare, Bedford Labs, Taro, Mylan, Wraser Pharms, Barr, Carlsbad, Pliva, Apotex Inc, Teva, Nostrum Labs, Idt Australia Ltd, Unique Pharm Labs, Depomed Inc, Sun Pharm Inds Ltd, Igi Labs Inc, Akorn Inc, Hikma, Aurobindo Pharma, Fdc Ltd, Alcon Pharms Ltd, Watson Labs Inc, Rising Pharms Inc, Ivax Sub Teva Pharms, Dr Reddys Labs Ltd, Sandoz, Watson Labs, Apotex, Pharmaforce, Laboratorios Salvat, Actavis Labs Fl Inc, Anchen Pharms, and Mylan Pharms Inc, and is included in sixty-one 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 six patent family members in seventeen countries.

There are thirty drug master file entries for ciprofloxacin. Ten suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: ciprofloxacin

Tradenames:16
Patents:16
Applicants:45
NDAs:61
Drug Master File Entries: see list30
Suppliers / Packaging: see list10
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for Ingredient: ciprofloxacin

Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial

Tentative approvals for CIPROFLOXACIN

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

Clinical Trials for: ciprofloxacin

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ivax Sub Teva Pharms
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL076089-004Jun 9, 2004RXNo<disabled><disabled>
Apotex Inc
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
SOLUTION/DROPS;OPHTHALMIC075928-001Jun 9, 2004DISCNNo<disabled><disabled>
Alcon Pharms Ltd
CIPRODEX
ciprofloxacin; dexamethasone
SUSPENSION/DROPS;OTIC021537-001Jul 18, 2003RXYes8,846,650<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: ciprofloxacin

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
ciprofloxacin
INJECTABLE;INJECTION019857-001Dec 26, 19904,808,583*PED<disabled>
Bayer Hlthcare
CIPRO
ciprofloxacin
FOR SUSPENSION;ORAL020780-002Sep 26, 19975,695,784*PED<disabled>
Bayer Hlthcare
CIPRO
ciprofloxacin
FOR SUSPENSION;ORAL020780-002Sep 26, 19976,136,347*PED<disabled>
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Non-Orange Book Patents for Generic Ingredient: ciprofloxacin

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,546,363Controlled release corticosteroid compositions and methods for the treatment of otic disorders<disabled in preview>
8,828,980Controlled release corticosteroid compositions and methods for the treatment of otic disorders<disabled in preview>
8,784,870Controlled release compositions for modulating free-radical induced damage and methods of use thereof<disabled in preview>
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International Patent Family for Ingredient: ciprofloxacin

Country Document Number Estimated Expiration
Russian Federation2010150863<disabled in preview>
Canada2730847<disabled in preview>
World Intellectual Property Organization (WIPO)2010011605<disabled in preview>
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Supplementary Protection Certificates for Tradename: CIPROFLOXACIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0012France<disabled>PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808
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