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Serving leading biopharmaceutical companies globally:

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Federal Trade Commission
Express Scripts
Baxter
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Generated: October 21, 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-six patent family members in nineteen countries and two supplementary protection certificates in two 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

US Patents:17
Tradenames:16
Applicants:45
NDAs:61
Drug Master File Entries: see list31
Suppliers / Packagers: see list10
Bulk Api Vendors: see list70
Clinical Trials: see list182
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
u► SubscribeEQ 750MG BASETABLET;ORAL
u► SubscribeEQ 500MG BASETABLET;ORAL
u► 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
Novartis Pharms Corp
CIPRODEX
ciprofloxacin; dexamethasone
SUSPENSION/DROPS;OTIC021537-001Jul 18, 2003RXYesYes► Subscribe► SubscribeY ► Subscribe
Anchen Pharms
CIPROFLOXACIN EXTENDED RELEASE
ciprofloxacin; ciprofloxacin hydrochloride
TABLET, EXTENDED RELEASE;ORAL078166-002Nov 27, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Depomed Inc
PROQUIN XR
ciprofloxacin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021744-001May 19, 2005DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Sun Pharm Inds Ltd
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL075747-001Jun 9, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Ltd
CIPROFLOXACIN EXTENDED RELEASE
ciprofloxacin; ciprofloxacin hydrochloride
TABLET, EXTENDED RELEASE;ORAL077701-001Mar 26, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL077859-001Apr 26, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Hikma
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL076558-002Jun 9, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Hikma Farmaceutica
CIPROFLOXACIN
ciprofloxacin
INJECTABLE;INJECTION076717-001Dec 22, 2009APRXNoNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
CIPRO XR
ciprofloxacin; ciprofloxacin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021473-002Aug 28, 2003DISCNNoNo► Subscribe► SubscribeY► Subscribe
Actavis Labs Fl Inc
CIPROFLOXACIN EXTENDED RELEASE
ciprofloxacin; ciprofloxacin hydrochloride
TABLET, EXTENDED RELEASE;ORAL077809-001Nov 30, 2010DISCNNoNo► Subscribe► 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 Hlthcare
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
ciprofloxacin
INJECTABLE;INJECTION019857-001Dec 26, 1990► Subscribe► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin
FOR SUSPENSION;ORAL020780-002Sep 26, 1997► Subscribe► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin
FOR SUSPENSION;ORAL020780-002Sep 26, 1997► Subscribe► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin
FOR SUSPENSION;ORAL020780-001Sep 26, 1997► Subscribe► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin
INJECTABLE;INJECTION019847-001Dec 26, 1990► Subscribe► Subscribe
Bayer Pharms
CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ciprofloxacin
INJECTABLE;INJECTION019858-001Dec 26, 1990► Subscribe► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin
FOR SUSPENSION;ORAL020780-001Sep 26, 1997► Subscribe► Subscribe
Bayer Pharms
CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ciprofloxacin
INJECTABLE;INJECTION019858-001Dec 26, 1990► Subscribe► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin
INJECTABLE;INJECTION019847-001Dec 26, 1990► Subscribe► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin
FOR SUSPENSION;ORAL020780-002Sep 26, 1997► Subscribe► 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
8,546,363Controlled release corticosteroid compositions and methods for the treatment of otic disorders► Subscribe
9,333,171Controlled-release CNS modulating compositions and methods for the treatment of otic disorders► Subscribe
9,066,855Controlled 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
9,511,020Controlled release corticosteroid compositions and methods for the treatment of otic disorders► Subscribe
8,030,297Controlled release corticosteroid compositions and methods for the treatment of OTIC disorders► Subscribe
8,658,626Controlled release corticosteroid compositions and methods for the treatment of otic disorders► Subscribe
9,603,796Controlled release antimicrobial compositions and methods for the treatment of otic disorders► Subscribe
8,852,626Controlled-release CNS modulating compositions and methods for the treatment of otic disorders► Subscribe
8,680,082Controlled release corticosteroid 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
TaiwanI382839► Subscribe
Japan2014101392► Subscribe
Japan2015164943► Subscribe
Russian Federation2499592► Subscribe
Japan5551685► Subscribe
Japan2017160232► Subscribe
Argentina072828► Subscribe
Uruguay31999► Subscribe
Taiwan200950787► Subscribe
European Patent Office2299976► 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
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
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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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Chinese Patent Office
Covington
Queensland Health
Johnson and Johnson
Healthtrust
US Army
Julphar
Baxter
Boehringer Ingelheim

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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