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Last Updated: November 21, 2024

CIPRO Drug Patent Profile

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Which patents cover Cipro, and when can generic versions of Cipro launch?

Cipro is a drug marketed by Bayer Hlthcare, Sandoz, Bayer Pharms, Chartwell, Baxter Hlthcare Corp, Bedford Labs, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Sentiss, Sun Pharm, Ani Pharms, Dr Reddys Labs Ltd, Endo Operations, Fosun Pharma, Rising, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rubicon, Sciegen Pharms Inc, The J Molner, Watson Labs Inc, Aiping Pharm Inc, Amneal, Aurobindo Pharma, Barr, Carlsbad, Hikma, Ivax Sub Teva Pharms, Natco, Nostrum Labs, Pliva, Sun Pharm Inds Ltd, Taro, Teva, Unique, Watson Labs, Yiling, Baxter Hlthcare, Bedford, Inforlife, and Teva Pharms. and is included in sixty NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

The generic ingredient in CIPRO is ciprofloxacin; dexamethasone. There are thirty-four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ciprofloxacin; dexamethasone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cipro

A generic version of CIPRO was approved as ciprofloxacin; dexamethasone by DR REDDYS on August 10^th, 2020.

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Summary for CIPRO

US Patents:	0
Applicants:	44
NDAs:	60
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	123
Patent Applications:	4,474
Drug Prices:	Drug price information for CIPRO
Drug Sales Revenues:	Drug sales revenues for CIPRO
What excipients (inactive ingredients) are in CIPRO?	CIPRO excipients list
DailyMed Link:	CIPRO at DailyMed

Drug patent expirations by year for CIPRO

Drug Prices for CIPRO

Pharmacology for CIPRO

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

Paragraph IV (Patent) Challenges for CIPRO

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 CIPRO

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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
Hikma	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076558-002	Jun 9, 2004	AB	RX	No	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
Rising	CIPROFLOXACIN EXTENDED RELEASE	ciprofloxacin; ciprofloxacin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	078183-001	Mar 22, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sentiss	CIPROFLOXACIN AND DEXAMETHASONE	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	215768-001	Jun 9, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pliva	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076426-004	Jun 15, 2005		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma Farmaceutica	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	078431-001	Nov 18, 2009	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
The J Molner	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	076754-001	Jun 9, 2004		DISCN	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 CIPRO

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-003	Oct 22, 1987	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	CIPRO	ciprofloxacin hydrochloride	TABLET;ORAL	019537-003	Oct 22, 1987	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	CIPRO	ciprofloxacin	FOR SUSPENSION;ORAL	020780-001	Sep 26, 1997	⤷ 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 Hlthcare	CIPRO	ciprofloxacin	INJECTABLE;INJECTION	019847-001	Dec 26, 1990	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	CIPRO	ciprofloxacin	INJECTABLE;INJECTION	019847-001	Dec 26, 1990	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for CIPRO

See the table below for patents covering CIPRO around the world.

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Country	Patent Number	Title	Estimated Expiration
Israel	104362	PHARMACEUTICAL COMPOSITIONS CONTAINING ACTIVE INGREDIENTS WHICH ARE FLAVOUR-MASKED BY MICROENCAPSULATION	⤷ Sign Up
Japan	H0643308		⤷ Sign Up
Denmark	162811		⤷ Sign Up
Japan	S6094910	LACTATE SOLUTION OF PIPERAZINYL-QUINOLONE AND PIPERAZINYL-AZAQUINOLONE CARBOXYLIC ACID	⤷ Sign Up
Australia	7468081		⤷ Sign Up
Japan	S5777683	7-AMINO-1-CYCLOPROPYL-4-OXO-1,4-DIHYDRO- NAPHTHYRIDINE-3-CARBOXYLIC ACIDS OR SALTS THEREOF, MANUFACTURE AND ANTIBACTERIAL THEREOF AS ACTIVE INGREDIENT	⤷ Sign Up
German Democratic Republic	227882	VERFAHREN ZUR HERSTELLUNG VON LOESUNGEN MILCHSAURER SALZE VON PIPERAZINYLCHINOLON- UND PIPERAZINYL-AZACHINOLONCARBONSAEUREN	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CIPRO

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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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