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Last Updated: November 29, 2022

Ciprofloxacin - Generic Drug Details


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What are the generic 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, Novartis, 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 Pharm Labs, Watson Labs, Yiling, Laboratorios Salvat, Anchen Pharms, Ani Pharms, Fosun Pharma, Mylan Pharms Inc, and Sun Pharm, and is included in sixty-four NDAs. There are thirteen 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-two 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 Hospital of SplitPhase 4
Lund UniversityPhase 3
Columbia UniversityPhase 4

See all ciprofloxacin clinical trials

Generic filers with tentative approvals for CIPROFLOXACIN
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and PricingEQ 750MG BASETABLET;ORAL
See Plans and PricingSee Plans and PricingEQ 500MG BASETABLET;ORAL
See Plans and PricingSee Plans and PricingEQ 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
Watson Labs CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076794-002 Jun 9, 2004 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Taro CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 076912-001 Feb 18, 2005 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis CIPRODEX ciprofloxacin; dexamethasone SUSPENSION/DROPS;OTIC 021537-001 Jul 18, 2003 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Rising CIPROFLOXACIN HYDROCHLORIDE ciprofloxacin hydrochloride TABLET;ORAL 075817-004 Jun 9, 2004 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare CIPRO ciprofloxacin INJECTABLE;INJECTION 019847-001 Dec 26, 1990 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare CIPRO ciprofloxacin INJECTABLE;INJECTION 019847-001 Dec 26, 1990 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER ciprofloxacin INJECTABLE;INJECTION 019857-001 Dec 26, 1990 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ciprofloxacin

Country Patent Number Title Estimated Expiration
Japan 6147653 See Plans and Pricing
Japan 2017160232 耳の障害の処置のための耳感覚細胞モジュレータ組成物の制御放出及びその方法 (CONTROLLED RELEASE OF AURIS SENSORY CELL MODULATOR COMPOSITIONS FOR TREATMENT OF OTIC DISORDERS AND METHODS THEREFOR) See Plans and Pricing
Mexico 2010011545 FORMULACIONES PARA TRATAR ENFERMEDADES Y AFECCIONES DEL OIDO. (AURIS FORMULATIONS FOR TREATING OTIC DISEASES AND CONDITIONS.) See Plans and Pricing
Japan 2016026218 耳の疾患と疾病を処置するための耳の製剤と関連する応用 (AURIS FORMULATION FOR TREATING OTIC DISEASE AND CONDITION AND APPLICATION RELATED THERETO) See Plans and Pricing
>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 See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
1429780 SPC/GB12/058 United Kingdom See Plans and Pricing 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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