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Serving leading biopharmaceutical companies globally:

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Cerilliant
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Generated: December 13, 2017

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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, Acs Dobfar Info Sa, Baxter Hlthcare, Bedford, 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, Hikma, Idt Australia Ltd, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sandoz, 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 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.

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
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 Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Bedford LabsCIPROFLOXACINciprofloxacinINJECTABLE;INJECTION076992-002Aug 28, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
SandozCIPROFLOXACIN EXTENDED RELEASEciprofloxacin; ciprofloxacin hydrochlorideTABLET, EXTENDED RELEASE;ORAL078712-001Dec 11, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Depomed IncPROQUIN XRciprofloxacin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021744-001May 19, 2005DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
Bayer HlthcareCIPRO XRciprofloxacin; ciprofloxacin hydrochlorideTABLET, EXTENDED RELEASE;ORAL021473-002Aug 28, 2003DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
BarrCIPROFLOXACIN HYDROCHLORIDEciprofloxacin hydrochlorideTABLET;ORAL074124-003Jun 9, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Teva PharmsCIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINERciprofloxacinINJECTABLE;INJECTION077138-002Mar 18, 2008DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Apotex IncCIPROFLOXACIN HYDROCHLORIDEciprofloxacin hydrochlorideSOLUTION/DROPS;OPHTHALMIC075928-001Jun 9, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Akorn IncCIPROFLOXACIN HYDROCHLORIDEciprofloxacin hydrochlorideSOLUTION/DROPS;OPHTHALMIC076555-001Dec 11, 2008ATRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Teva Pharms UsaCIPROFLOXACINciprofloxacinINJECTABLE;INJECTION077782-002Aug 28, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Bayer HlthcareCIPROciprofloxacin hydrochlorideTABLET;ORAL019537-004Oct 22, 1987ABRXYesNo► Subscribe► 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 PharmsCIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERciprofloxacinINJECTABLE;INJECTION019858-001Dec 26, 1990► Subscribe► Subscribe
Bayer HlthcareCIPROciprofloxacinINJECTABLE;INJECTION019847-001Dec 26, 1990► Subscribe► Subscribe
Bayer PharmsCIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERciprofloxacinINJECTABLE;INJECTION019858-001Dec 26, 1990► Subscribe► Subscribe
Bayer HlthcareCIPRO IN DEXTROSE 5% IN PLASTIC CONTAINERciprofloxacinINJECTABLE;INJECTION019857-001Dec 26, 1990► Subscribe► Subscribe
Bayer HlthcareCIPROciprofloxacinFOR SUSPENSION;ORAL020780-001Sep 26, 1997► Subscribe► Subscribe
Bayer HlthcareCIPROciprofloxacinINJECTABLE;INJECTION019847-001Dec 26, 1990► Subscribe► Subscribe
Bayer HlthcareCIPRO IN DEXTROSE 5% IN PLASTIC CONTAINERciprofloxacinINJECTABLE;INJECTION019857-001Dec 26, 1990► Subscribe► Subscribe
Bayer HlthcareCIPROciprofloxacinINJECTABLE;INJECTION019847-001Dec 26, 1990► Subscribe► Subscribe
Bayer HlthcareCIPROciprofloxacinFOR SUSPENSION;ORAL020780-002Sep 26, 1997► Subscribe► Subscribe
Bayer HlthcareCIPROciprofloxacinFOR 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
9,511,020Controlled 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
8,648,119Controlled release immunomodulator compositions and methods for the treatment of otic disorders► Subscribe
9,744,126Controlled release corticosteroid 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
8,828,980Controlled 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
9,427,472Controlled release compositions for modulating free-radical induced damage and methods of use thereof► Subscribe
8,846,770Controlled release aural pressure 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
Canada2723458► Subscribe
United Kingdom0823378► Subscribe
Taiwan200950787► Subscribe
Israel208806► Subscribe
European Patent Office2299979► Subscribe
European Patent Office2299976► Subscribe
World Intellectual Property Organization (WIPO)2010011466► Subscribe
China102026623► Subscribe
Malaysia161021► Subscribe
Japan5491502► 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:

Queensland Health
Novartis
UBS
Chinese Patent Office
Cerilliant
Merck
Julphar
Colorcon
Moodys
Mallinckrodt

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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