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Last Updated: March 28, 2024

Ciprofloxacin - Generic Drug Details


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

Ciprofloxacin is the generic ingredient in seventeen branded drugs marketed by Bayer Hlthcare, Chartwell, Alk Abello, Bayer Pharms, Baxter Hlthcare Corp, Bedford Labs, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Baxter Hlthcare, Bedford, Inforlife, Teva Pharms, Sandoz, Akorn, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Pai Holdings Pharm, Rising, Rubicon, Watson Labs Inc, Wraser Pharms, Depomed Inc, Aiping Pharm Inc, Amneal, Aurobindo Pharma, Barr, Carlsbad, Dr Reddys Labs Ltd, Hikma, Ivax Sub Teva Pharms, Mylan, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique, Watson Labs, Yiling, Laboratorios Salvat, Anchen Pharms, Ani Pharms, Fosun Pharma, Sentiss, and Sun Pharm, and is included in sixty-five NDAs. There are ten 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 fifty 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

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

SponsorPhase
University of Missouri-ColumbiaPhase 4
SanofiPhase 1
Institut de Recherches Internationales ServierPhase 1

See all ciprofloxacin clinical trials

Generic filers with tentative approvals for CIPROFLOXACIN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialEQ 750MG BASETABLET;ORAL
⤷  Try a Trial⤷  Try a TrialEQ 500MG BASETABLET;ORAL
⤷  Try a Trial⤷  Try a 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 Strength NDA ANDAs Submitted Submissiondate
CIPRO Oral Suspension ciprofloxacin 250 mg/5 mL and 500 mg/ 5 mL 020780 1 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
Nostrum Labs CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076138-002 Jun 9, 2004 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira CIPROFLOXACIN ciprofloxacin INJECTABLE;INJECTION 077245-001 Aug 28, 2006 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Ltd CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 075593-003 Jun 9, 2004 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa CIPROFLOXACIN ciprofloxacin INJECTABLE;INJECTION 076484-001 Aug 28, 2006 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nostrum Labs CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076138-001 Jun 9, 2004 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076896-001 Nov 4, 2004 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

International Patents for ciprofloxacin

Country Patent Number Title Estimated Expiration
Japan 2014101392 CONTROLLED RELEASE-TYPE CORTICOSTEROID COMPOSITION AND METHOD FOR TREATING EAR DISEASE ⤷  Try a Trial
Canada 2731766 COMPOSITIONS ANTIMICROBIENNES A LIBERATION CONTROLEE ET PROCEDES POUR LE TRAITEMENT DE TROUBLES OTIQUES (CONTROLLED RELEASE ANTIMICROBIAL COMPOSITIONS AND METHODS FOR THE TREATMENT OF OTIC DISORDERS) ⤷  Try a Trial
Israel 208549 הרכבי אוריס לטיפול במחלות אוזניים ובתנאים (Auris formulations for treating otic diseases and conditions) ⤷  Try a Trial
Japan 2014058557 AURIS FORMULATION FOR TREATING OTIC DISEASE AND CONDITION AND APPLICATION RELATED TO AURIS FORMULATION ⤷  Try a Trial
China 104940126 Controlled-release otic structure modulating and innate immune system modulating compositions and methods for the treatment of otic disorders ⤷  Try a Trial
Australia 2009271129 Controlled-release apoptosis modulating compositions and methods for the treatment of otic disorders ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ciprofloxacin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1429780 122012000070 Germany ⤷  Try a 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 SPC/GB12/058 United Kingdom ⤷  Try a 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 ⤷  Try a Trial PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
1429780 13C0012 France ⤷  Try a 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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