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Last Updated: March 29, 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

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SponsorPhase
University of Missouri-ColumbiaPhase 4
SanofiPhase 1
Servier Bio-Innovation LLCPhase 1

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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
Bayer Hlthcare CIPRO ciprofloxacin INJECTABLE;INJECTION 019847-002 Dec 26, 1990 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ciprofloxacin INJECTABLE;INJECTION 077888-001 Mar 18, 2008 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare Corp CIPROFLOXACIN ciprofloxacin INJECTABLE;INJECTION 078062-001 Apr 29, 2008 AP RX No Yes ⤷  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

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

International Patents for ciprofloxacin

Country Patent Number Title Estimated Expiration
Australia 2009274137 Controlled release antimicrobial compositions and methods for the treatment of otic disorders ⤷  Try a Trial
South Africa 201007001 AURIS FORMULATIONS FOR TREATING OTIC DISEASES AND CONDITIONS ⤷  Try a Trial
Russian Federation 2499592 ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ЛЕЧЕНИЯ УШНЫХ ЗАБОЛЕВАНИЙ (PHARMACEUTICAL COMPOSITION FOR TREATING EAR DISEASES) ⤷  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 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
1429780 132013902137451 Italy ⤷  Try a Trial PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
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
>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.