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Last Updated: November 30, 2022

Ciprofloxacin hydrochloride - Generic Drug Details


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What are the generic sources for ciprofloxacin hydrochloride and what is the scope of patent protection?

Ciprofloxacin hydrochloride is the generic ingredient in seven branded drugs marketed by Novartis, Akorn, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Pai Holdings Pharm, Rising, Rubicon, Watson Labs Inc, Wraser Pharms, Depomed Inc, Bayer Hlthcare, Aiping Pharm Inc, Amneal, Aurobindo Pharma, Barr, Carlsbad, Chartwell, Dr Reddys Labs Ltd, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique Pharm Labs, Watson Labs, Yiling, and Laboratorios Salvat, and is included in thirty-four NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for ciprofloxacin hydrochloride. Fifty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for ciprofloxacin hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University Hospital of SplitPhase 4
Lund UniversityPhase 3
Atlantic Health SystemPhase 4

See all ciprofloxacin hydrochloride clinical trials

Generic filers with tentative approvals for CIPROFLOXACIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 500MG BASETABLET;ORAL
See Plans and PricingSee Plans and PricingEQ 250MG BASETABLET;ORAL
See Plans and PricingSee Plans and PricingEQ 750MG BASETABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ciprofloxacin hydrochloride

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
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-002 Oct 22, 1987 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 075685-001 Jun 9, 2004 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Rising CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 075817-003 Jun 9, 2004 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 077859-003 Apr 26, 2007 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-004 Oct 22, 1987 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076794-001 Feb 10, 2005 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ciprofloxacin hydrochloride

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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 verification 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.