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Ciprofloxacin - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for ciprofloxacin?

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, Teligent Pharma Inc, Akorn Inc, Hikma, Aurobindo Pharma, Fdc Ltd, Novartis Pharms Corp, 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 seventeen 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 eighteen patent family members in eighteen countries.

There are thirty-one 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:18
Applicants:45
NDAs:61
Drug Master File Entries: see list31
Suppliers / Packagers: see list10
Bulk Api Vendors: see list70
Clinical Trials: see list55
Patent Applications: see list6,379
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ciprofloxacin at DailyMed

Pharmacology for Ingredient: ciprofloxacin

Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial

Tentative approvals for CIPROFLOXACIN

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET; ORAL100MG
► Subscribe► SubscribeTablet; Oral100MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fdc Ltd
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
SOLUTION/DROPS;OPHTHALMIC077568-001Jun 30, 2008RXNoNo► Subscribe► Subscribe
Teva
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL076136-002Jun 9, 2004DISCNNoNo► Subscribe► Subscribe
Hikma Farmaceutica
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ciprofloxacin
INJECTABLE;INJECTION078431-001Nov 18, 2009RXNoNo► Subscribe► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin hydrochloride
TABLET;ORAL019537-004Oct 22, 1987RXYesNo► Subscribe► Subscribe
Mylan
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL075817-001Jun 25, 2007RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ciprofloxacin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Pharms
CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ciprofloxacin
INJECTABLE;INJECTION019858-001Dec 26, 19904,808,583*PED► Subscribe
Bayer Hlthcare
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
ciprofloxacin
INJECTABLE;INJECTION019857-001Dec 26, 19904,808,583*PED► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin
FOR SUSPENSION;ORAL020780-001Sep 26, 19974,670,444*PED► Subscribe
Bayer Hlthcare
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
ciprofloxacin
INJECTABLE;INJECTION019857-001Dec 26, 19904,670,444*PED► Subscribe
Bayer Hlthcare
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
ciprofloxacin
INJECTABLE;INJECTION019857-001Dec 26, 19904,957,922*PED► Subscribe
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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
8,030,297Controlled release corticosteroid compositions and methods for the treatment of OTIC disorders► Subscribe
8,546,363Controlled release corticosteroid compositions and methods for the treatment of otic disorders► Subscribe
9,132,087Auris formulations for treating otic diseases and conditions► Subscribe
8,648,119Controlled release immunomodulator compositions and methods for the treatment of otic disorders► Subscribe
8,496,957Controlled release auris sensory cell modulator compositions and methods for the treatment of otic disorders► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: ciprofloxacin

Country Document Number Estimated Expiration
South Korea101390607► Subscribe
Hong Kong1156533► Subscribe
European Patent Office2299979► Subscribe
Japan2016164164► Subscribe
Russian Federation2011105257► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: CIPROFLOXACIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0012France► SubscribePRODUCT 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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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 verifification 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.

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