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Serving 500+ biopharmaceutical companies globally:

Teva
Cerilliant
Chubb
Julphar
Dow
US Department of Justice
Medtronic
Mallinckrodt
Boehringer Ingelheim
Accenture

Generated: September 22, 2017

DrugPatentWatch Database Preview

Ciprofloxacin - Generic Drug Details

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What are the generic sources for ciprofloxacin and what is the scope of ciprofloxacin patent protection?

Ciprofloxacin
is the generic ingredient in sixteen branded drugs marketed by Bedford, Hikma Farmaceutica, Baxter Hlthcare Corp, 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 Pharm, Mylan, Wraser Pharms, Barr, Carlsbad, Pliva, Apotex Inc, Teva, Nostrum Labs, Idt Australia Ltd, Unique Pharm Labs, Depomed Inc, Sun Pharm Inds Ltd, Teligent, 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, Amring Pharms, 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.

Ciprofloxacin has one hundred and twenty-one 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 five tentative approvals for this compound.

Summary for Generic Name: ciprofloxacin

Tradenames:16
Patents:17
Applicants:45
NDAs:61
Drug Master File Entries: see list31
Suppliers / Packagers: see list10
Bulk Api Vendors: see list70
Clinical Trials: see list181
Patent Applications: see list7,464
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. Strength Dosage Form
► Subscribe► SubscribeEQ 750MG BASETABLET;ORAL
► Subscribe► SubscribeEQ 500MG BASETABLET;ORAL
► Subscribe► SubscribeEQ 250MG BASETABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL075817-004Jun 9, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
CIPROFLOXACIN
ciprofloxacin
FOR SUSPENSION;ORAL200563-002Mar 5, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Baxter Hlthcare Corp
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ciprofloxacin
INJECTABLE;INJECTION078024-002Mar 18, 2008APRXNoNo► Subscribe► Subscribe► Subscribe
Mylan
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL075685-003Jun 9, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
CIPROFLOXACIN
ciprofloxacin
INJECTABLE;INJECTION076484-002Aug 28, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe
Sandoz
CIPROFLOXACIN EXTENDED RELEASE
ciprofloxacin; ciprofloxacin hydrochloride
TABLET, EXTENDED RELEASE;ORAL078712-001Dec 11, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Novartis Pharms Corp
CIPRODEX
ciprofloxacin; dexamethasone
SUSPENSION/DROPS;OTIC021537-001Jul 18, 2003RXYesYes► Subscribe► SubscribeY ► Subscribe
Watson Labs
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL076794-003Jun 9, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL075817-001Jun 25, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL076794-002Jun 9, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ciprofloxacin

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
8,784,870Controlled release compositions for modulating free-radical induced damage and methods of use thereof► Subscribe
9,427,472Controlled release compositions for modulating free-radical induced damage and methods of use thereof► Subscribe
8,828,980Controlled release corticosteroid compositions and methods for the treatment of otic disorders► Subscribe
9,132,087Auris formulations for treating otic diseases and conditions► Subscribe
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
9,511,020Controlled release corticosteroid 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
8,846,770Controlled release aural pressure modulator compositions and methods for the treatment of OTIC disorders► Subscribe
8,399,018Controlled release ion channel 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
Canada2732686► Subscribe
Australia2009246870► Subscribe
South Korea101534422► Subscribe
China102105133► Subscribe
TaiwanI450732► Subscribe
Russian Federation2011105257► Subscribe
European Patent Office2299979► Subscribe
Russian Federation2010150863► Subscribe
World Intellectual Property Organization (WIPO)2016004231► Subscribe
Taiwan201004633► 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
C/GB12/058United Kingdom► SubscribePRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Colorcon
QuintilesIMS
Mallinckrodt
Johnson and Johnson
UBS
Cipla
Boehringer Ingelheim
Harvard Business School
Fish and Richardson
Cantor Fitzgerald

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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