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Last Updated: April 18, 2024

Ciprofloxacin - Generic Drug Details

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What are the generic sources for ciprofloxacin and what is the scope of freedom to operate?

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.

Summary for ciprofloxacin

International Patents:	150
US Patents:	10
Tradenames:	17
Applicants:	48
NDAs:	65
Drug Master File Entries:	34
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	297
Patent Applications:	7,194
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ciprofloxacin
Drug Sales Revenues:	Drug sales revenues for ciprofloxacin
What excipients (inactive ingredients) are in ciprofloxacin?	ciprofloxacin excipients list
DailyMed Link:	ciprofloxacin at DailyMed

See drug prices for ciprofloxacin

Drug Sales Revenue Trends for ciprofloxacin

See drug sales revenues for ciprofloxacin

Recent Clinical Trials for ciprofloxacin

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

Sponsor	Phase
University of Missouri-Columbia	Phase 4
Sanofi	Phase 1
Institut de Recherches Internationales Servier	Phase 1

See all ciprofloxacin clinical trials

Generic filers with tentative approvals for CIPROFLOXACIN

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	EQ 750MG BASE	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	EQ 500MG BASE	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	EQ 250MG BASE	TABLET;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

Drug Class	Fluoroquinolone Antibacterial Quinolone Antimicrobial
Mechanism of Action	Cytochrome P450 1A2 Inhibitors

Medical Subject Heading (MeSH) Categories for ciprofloxacin

Anti-Bacterial Agents
Cytochrome P-450 CYP1A2 Inhibitors
Topoisomerase II Inhibitors

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alk Abello	OTIPRIO	ciprofloxacin	INJECTABLE, SUSPENSION;OTIC	207986-001	Dec 10, 2015		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma Farmaceutica	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	078431-001	Nov 18, 2009	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm	CIPROFLOXACIN AND DEXAMETHASONE	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	210470-001	Aug 30, 2022	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	CIPRO	ciprofloxacin	FOR SUSPENSION;ORAL	020780-001	Sep 26, 1997	⤷ Try a Trial	⤷ Try a Trial
Bayer Hlthcare	CIPRO	ciprofloxacin	FOR SUSPENSION;ORAL	020780-002	Sep 26, 1997	⤷ Try a Trial	⤷ Try a Trial
Bayer Hlthcare	CIPRO	ciprofloxacin	FOR SUSPENSION;ORAL	020780-002	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

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Country	Patent Number	Title	Estimated Expiration
Uruguay	31779	FORMULACIONES PARA EL OÍDO PARA TRATAR ENFERMEDADES Y CONDICIONES OPTICAS	⤷ Try a Trial
Australia	2009239429	Auris formulations for treating otic diseases and conditions	⤷ Try a Trial
Peru	20100137	COMPOSICIONES ANTIMICROBIANAS DE LIBERACION CONTROLADA Y METODOS PARA EL TRATAMIENTO DE TRASTORNOS OTICOS	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ciprofloxacin

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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	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
>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.