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Last Updated: August 9, 2020

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Ciprofloxacin hydrochloride - Generic Drug Details

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What are the generic drug sources for ciprofloxacin hydrochloride and what is the scope of freedom to operate?

Ciprofloxacin hydrochloride is the generic ingredient in seven branded drugs marketed by Novartis, Akorn Inc, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Teligent, Watson Labs Inc, Wraser Pharms, Depomed Inc, Bayer Hlthcare, 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, Yiling Pharm Ltd, and Laboratorios Salvat, and is included in thirty-four NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ciprofloxacin hydrochloride has nineteen patent family members in fourteen countries.

There are thirty-four drug master file entries for ciprofloxacin hydrochloride. Fifty-one 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 of OxfordPhase 4
Women and Children's Health Research Institute, CanadaPhase 4
Department for International Development, United KingdomPhase 4

See all ciprofloxacin hydrochloride clinical trials

Generic filers with tentative approvals for CIPROFLOXACIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 750MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 500MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 250MG 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
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
Chartwell CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076896-002 Nov 4, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Novartis CILOXAN ciprofloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 019992-001 Dec 31, 1990 AT RX Yes Yes   Start Trial   Start Trial   Start Trial
Altaire Pharms Inc CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 204613-001 May 3, 2018 AT 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

Expired US Patents for ciprofloxacin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-004 Oct 22, 1987   Start Trial   Start Trial
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-003 Oct 22, 1987   Start Trial   Start Trial
Depomed Inc PROQUIN XR ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021744-001 May 19, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ciprofloxacin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1429780 SPC/GB12/058 United Kingdom   Start Trial 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
1429780 132013902137451 Italy   Start Trial PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
1429780 13C0012 France   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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