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Last Updated: April 20, 2021

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Ciprofloxacin - Generic Drug Details

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

Ciprofloxacin is the generic ingredient in seventeen branded drugs marketed by Bayer Hlthcare, Chartwell, Otonomy Inc, Bayer Pharms, Baxter Hlthcare Corp, Bedford Labs, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Baxter Hlthcare, Bedford, Inforlife, Teva Pharms, Novartis, Akorn Inc, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Teligent, Watson Labs Inc, Wraser Pharms, Depomed Inc, Ani Pharms Inc, Aurobindo Pharma, Barr, Carlsbad, 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, Laboratorios Salvat, Anchen Pharms, and Mylan Pharms Inc, and is included in sixty-three NDAs. There are fifteen 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 forty-six patent family members in twenty countries.

There are thirty-four drug master file entries for ciprofloxacin. Five suppliers are listed for this compound. There are four tentative approvals for this compound.

Drug Prices for ciprofloxacin

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Drug Sales Revenue Trends for ciprofloxacin

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Recent Clinical Trials for ciprofloxacin

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SponsorPhase
National Institute for Health Research, United KingdomN/A
University College, LondonN/A
Lee's Pharmaceutical LimitedPhase 3

See all ciprofloxacin clinical trials

Generic filers with tentative approvals for CIPROFLOXACIN
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
Medical Subject Heading (MeSH) Categories for ciprofloxacin
Paragraph IV (Patent) Challenges for CIPROFLOXACIN
Tradename Dosage Ingredient NDA Submissiondate
CIPRO FOR SUSPENSION;ORAL ciprofloxacin 020780 2009-10-16

US Patents and Regulatory Information for ciprofloxacin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076794-002 Jun 9, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Bayer Hlthcare CIPRO ciprofloxacin INJECTABLE;INJECTION 019847-001 Dec 26, 1990 DISCN Yes No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd CIPROFLOXACIN EXTENDED RELEASE ciprofloxacin; ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 077701-001 Mar 26, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Bayer Hlthcare CIPRO ciprofloxacin hydrochloride TABLET;ORAL 019537-003 Oct 22, 1987 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Taro CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076912-003 Oct 6, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Novartis CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 AB RX Yes Yes   Start Trial   Start Trial Y   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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-001 Sep 26, 1997   Start Trial   Start Trial
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-002 Sep 26, 1997   Start Trial   Start Trial
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-002 Sep 26, 1997   Start Trial   Start Trial
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-001 Sep 26, 1997   Start Trial   Start Trial
Bayer Hlthcare CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER ciprofloxacin INJECTABLE;INJECTION 019857-001 Dec 26, 1990   Start Trial   Start Trial
Bayer Hlthcare CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER ciprofloxacin INJECTABLE;INJECTION 019857-001 Dec 26, 1990   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ciprofloxacin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1429780 122012000070 Germany   Start Trial PRODUCT NAME: KOMBINATION AUS CIPROFLOXACIN UND DEXAMETHASON, INSBESONDERE CIPROFLOXACINHYDROCHLORID UND DEXAMETHASON; NAT. REGISTRATION NO/DATE: 85150.00. 00 20120830; FIRST REGISTRATION: DAENEMARK 48976 20120808
1429780 132013902137451 Italy   Start Trial PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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