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Ciprofloxacin hydrochloride - Generic Drug Details

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

Ciprofloxacin hydrochloride is the generic ingredient in seven branded drugs marketed by Taro, Mylan, Wraser Pharms, Barr, Carlsbad, Pliva, Apotex Inc, Teva, Bayer Hlthcare, 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, and Laboratorios Salvat, and is included in thirty-two NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-five patent family members in seventeen countries.

There are thirty-one drug master file entries for ciprofloxacin hydrochloride. Seventy-one suppliers are listed for this compound.

Summary for Generic Name: ciprofloxacin hydrochloride

Tradenames:7
Patents:6
Applicants:29
NDAs:32
Drug Master File Entries: see list31
Suppliers / Packagers: see list71
Bulk Api Vendors: see list49
Clinical Trials: see list1,035
Patent Applications: see list1,350
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ciprofloxacin hydrochloride at DailyMed

Pharmacology for Ingredient: ciprofloxacin hydrochloride

Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Depomed Inc
PROQUIN XR
ciprofloxacin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021744-001May 19, 2005DISCNNoNo6,488,962► SubscribeY ► Subscribe
Watson Labs Inc
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
SOLUTION/DROPS;OPHTHALMIC076673-001Jan 21, 2005RXNoNo► Subscribe► Subscribe
Sandoz
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL076593-003Jun 9, 2004DISCNNoNo► Subscribe► Subscribe
Sun Pharm Inds Ltd
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL075747-001Jun 9, 2004RXNoNo► Subscribe► Subscribe
Watson Labs
CIPROFLOXACIN HYDROCHLORIDE
ciprofloxacin hydrochloride
TABLET;ORAL076794-003Jun 9, 2004RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ciprofloxacin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp
CILOXAN
ciprofloxacin hydrochloride
OINTMENT;OPHTHALMIC020369-001Mar 30, 19984,670,444*PED► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin hydrochloride
TABLET;ORAL019537-003Oct 22, 19874,670,444*PED► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin hydrochloride
TABLET;ORAL019537-003Oct 22, 19875,286,754*PED► Subscribe
Depomed Inc
PROQUIN XR
ciprofloxacin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021744-001May 19, 20055,972,389► Subscribe
Bayer Hlthcare
CIPRO
ciprofloxacin hydrochloride
TABLET;ORAL019537-004Oct 22, 19875,286,754*PED► Subscribe
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International Patent Family for Ingredient: ciprofloxacin hydrochloride

Country Document Number Estimated Expiration
Austria256455► Subscribe
Japan2009040787► Subscribe
Australia2001239893► Subscribe
Canada2364845► Subscribe
Japan2016166239► 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 HYDROCHLORIDE

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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