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Last Updated: August 6, 2020

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CIPROFLOXACIN HYDROCHLORIDE Drug Profile

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Which patents cover Ciprofloxacin Hydrochloride, and what generic alternatives are available?

Ciprofloxacin Hydrochloride is a drug marketed by Akorn Inc, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Teligent, Watson Labs Inc, Ani Pharms Inc, Aurobindo Pharma, Barr, Carlsbad, Chartwell, Dr Reddys Labs Ltd, Fosun Pharma, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique Pharm Labs, Watson Labs, and Yiling Pharm Ltd. and is included in twenty-seven NDAs.

The generic ingredient in CIPROFLOXACIN HYDROCHLORIDE is ciprofloxacin hydrochloride. There are thirty-four drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the ciprofloxacin hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Ciprofloxacin Hydrochloride

A generic version of CIPROFLOXACIN HYDROCHLORIDE was approved as ciprofloxacin hydrochloride by TELIGENT on June 9th, 2004.

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Drug patent expirations by year for CIPROFLOXACIN HYDROCHLORIDE
Recent Clinical Trials for CIPROFLOXACIN HYDROCHLORIDE

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SponsorPhase
Department for International Development, United KingdomPhase 4
Wellcome TrustPhase 4
Medical Research CouncilPhase 4

See all CIPROFLOXACIN HYDROCHLORIDE clinical trials

Pharmacology for CIPROFLOXACIN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for CIPROFLOXACIN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
CIPRO TABLET;ORAL ciprofloxacin hydrochloride 019537

US Patents and Regulatory Information for CIPROFLOXACIN HYDROCHLORIDE

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;ORAL 075685-003 Jun 9, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076558-002 Jun 9, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Pliva CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076426-002 Jun 15, 2005 DISCN No No   Start Trial   Start Trial   Start Trial
Teva CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076136-002 Jun 9, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Nostrum Labs CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076138-001 Jun 9, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Pliva CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076426-003 Jun 15, 2005 DISCN No No   Start Trial   Start Trial   Start Trial
Taro CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076912-001 Feb 18, 2005 AB RX No No   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

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