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Last Updated: August 3, 2020

DrugPatentWatch Database Preview

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 sixteen branded drugs marketed by Bayer Hlthcare, Lupin Ltd, 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, 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, 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-three patent family members in twenty countries.

There are thirty-four drug master file entries for ciprofloxacin. Four 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

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

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

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
Ani Pharms Inc CIPROFLOXACIN EXTENDED RELEASE ciprofloxacin; ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 077417-001 Nov 30, 2010 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
Bedford CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ciprofloxacin INJECTABLE;INJECTION 078114-002 Mar 18, 2008 DISCN 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Pharms CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER ciprofloxacin INJECTABLE;INJECTION 019858-001 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
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-002 Sep 26, 1997   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 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Medtronic
Moodys
Johnson and Johnson
Boehringer Ingelheim

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