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Serving leading biopharmaceutical companies globally:

US Department of Justice
Merck
Chinese Patent Office
Dow
Cantor Fitzgerald
Cipla
Chubb
Medtronic
Citi
Julphar

Generated: February 19, 2018

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 Bayer Hlthcare, Lupin Ltd, Otonomy Inc, Bayer Pharms, Baxter Hlthcare Corp, Bedford Labs, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Teva Pharms Usa, Baxter Hlthcare, Bedford, Inforlife, Teva Pharms, Novartis Pharms Corp, Akorn Inc, Amring Pharms, Apotex Inc, Fdc Ltd, Rising Pharms Inc, Teligent, Watson Labs Inc, Wraser Pharms, Depomed Inc, Apotex, Aurobindo Pharma, Barr, Carlsbad, Dr Reddys Labs Ltd, Fosun Pharma, Hikma, Idt Australia Ltd, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro Pharm, Teva, Unique Pharm Labs, Watson Labs, Laboratorios Salvat, Actavis Labs Fl Inc, Anchen Pharms, and Mylan Pharms Inc, and is included in sixty-one NDAs. There are fourteen 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-seven patent family members in nineteen 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 ciprofloxacin
Pharmacology for ciprofloxacin
Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial
Medical Subject Heading (MeSH) Categories for ciprofloxacin
Tentative approvals for CIPROFLOXACIN
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign UpEQ 750MG BASETABLET;ORAL
➤ Sign Up➤ Sign UpEQ 500MG BASETABLET;ORAL
➤ Sign Up➤ Sign UpEQ 250MG BASETABLET;ORAL

US Patents and Regulatory Information for ciprofloxacin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Idt Australia Ltd CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 075939-001 Mar 3, 2005 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Inforlife CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ciprofloxacin INJECTABLE;INJECTION 078252-001 Mar 18, 2008 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Idt Australia Ltd CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 075939-002 Jun 9, 2004 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hospira CIPROFLOXACIN ciprofloxacin INJECTABLE;INJECTION 077245-001 Aug 28, 2006 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Otonomy Inc OTIPRIO ciprofloxacin INJECTABLE, SUSPENSION;OTIC 207986-001 Dec 10, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Mylan CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 075685-002 Jun 9, 2004 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Wraser Pharms CETRAXAL ciprofloxacin hydrochloride SOLUTION/DROPS;OTIC 021918-001 May 1, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Actavis Labs Fl Inc CIPROFLOXACIN EXTENDED RELEASE ciprofloxacin; ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 077417-001 Nov 30, 2010 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Taro Pharm CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076912-004 Oct 6, 2004 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bedford CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ciprofloxacin INJECTABLE;INJECTION 078114-002 Mar 18, 2008 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for 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;INJECTION 019858-001 Dec 26, 1990 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-001 Sep 26, 1997 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-002 Sep 26, 1997 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CIPRO ciprofloxacin INJECTABLE;INJECTION 019847-001 Dec 26, 1990 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER ciprofloxacin INJECTABLE;INJECTION 019857-001 Dec 26, 1990 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-002 Sep 26, 1997 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CIPRO ciprofloxacin INJECTABLE;INJECTION 019847-001 Dec 26, 1990 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER ciprofloxacin INJECTABLE;INJECTION 019857-001 Dec 26, 1990 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CIPRO ciprofloxacin INJECTABLE;INJECTION 019847-001 Dec 26, 1990 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-002 Sep 26, 1997 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
8,852,626 Controlled-release CNS modulating compositions and methods for the treatment of otic disorders ➤ Sign Up
9,427,472 Controlled release compositions for modulating free-radical induced damage and methods of use thereof ➤ Sign Up
8,030,297 Controlled release corticosteroid compositions and methods for the treatment of OTIC disorders ➤ Sign Up
8,496,957 Controlled release auris sensory cell modulator compositions and methods for the treatment of otic disorders ➤ Sign Up
8,680,082 Controlled release corticosteroid compositions and methods for the treatment of otic disorders ➤ Sign Up
9,808,460 Controlled release auris sensory cell modulator compositions and methods for the treatment of otic disorders ➤ Sign Up
9,511,020 Controlled release corticosteroid compositions and methods for the treatment of otic disorders ➤ Sign Up
8,846,770 Controlled release aural pressure modulator compositions and methods for the treatment of OTIC disorders ➤ Sign Up
9,757,484 Sterilization of ciprofloxacin composition ➤ Sign Up
8,546,363 Controlled release corticosteroid compositions and methods for the treatment of otic disorders ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for ciprofloxacin

Supplementary Protection Certificates for ciprofloxacin

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0012 France ➤ Sign Up 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
C/GB12/058 United Kingdom ➤ Sign Up PRODUCT 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Moodys
Chubb
Daiichi Sankyo
Baxter
Fish and Richardson
Dow
Boehringer Ingelheim
Citi

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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