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Last Updated: July 21, 2024

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 eighteen 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, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Pai Holdings Pharm, Rising, Rubicon, Saptalis Pharms, Watson Labs Inc, Key Therap, 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-six 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
Shanghai Pulmonary Hospital, Shanghai, ChinaPhase 4
University of Missouri-ColumbiaPhase 4
SanofiPhase 1

See all ciprofloxacin clinical trials

Generic filers with tentative approvals for CIPROFLOXACIN
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign UpEQ 750MG BASETABLET;ORAL
⤷  Sign Up⤷  Sign UpEQ 500MG BASETABLET;ORAL
⤷  Sign Up⤷  Sign UpEQ 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
Sun Pharm Inds Ltd CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 075747-003 Jun 9, 2004 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alk Abello OTIPRIO ciprofloxacin INJECTABLE, SUSPENSION;OTIC 207986-001 Dec 10, 2015 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Unique CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076639-003 Sep 10, 2004 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz CILOXAN ciprofloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 019992-001 Dec 31, 1990 AT RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Ltd CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 075593-003 Jun 9, 2004 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 IN DEXTROSE 5% IN PLASTIC CONTAINER ciprofloxacin INJECTABLE;INJECTION 019857-001 Dec 26, 1990 ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-002 Sep 26, 1997 ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-002 Sep 26, 1997 ⤷  Sign Up ⤷  Sign Up
Bayer Pharms CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER ciprofloxacin INJECTABLE;INJECTION 019858-001 Dec 26, 1990 ⤷  Sign Up ⤷  Sign Up
Bayer Hlthcare CIPRO ciprofloxacin FOR SUSPENSION;ORAL 020780-001 Sep 26, 1997 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ciprofloxacin

Country Patent Number Title Estimated Expiration
Japan 5491502 ⤷  Sign Up
Uruguay 31827 COMPOSICIONES CORTICOESTEROIDES DE LIBERACIÓN CONTROLADA Y MÉTODOS PARA EL TRATAMIENTO DE ENFERMEDADES ÓTICAS ⤷  Sign Up
Australia 2009239429 Auris formulations for treating otic diseases and conditions ⤷  Sign Up
South Korea 101367479 ⤷  Sign Up
China 103417472 Controlled release corticosteroid compositions and methods for the treatment of otic disorders ⤷  Sign Up
>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 ⤷  Sign Up 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 ⤷  Sign Up 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 ⤷  Sign Up PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
1429780 13C0012 France ⤷  Sign Up 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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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.