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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, Otonomy Inc, Bayer Pharms, Baxter Hlthcare Corp, Bedford Labs, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Hospira, Baxter Hlthcare, Bedford, Inforlife, Teva Pharms, Novartis, Akorn Inc, Altaire Pharms Inc, Amring Pharms, Fdc Ltd, Rising, Rubicon, Teligent, Watson Labs Inc, Wraser Pharms, Depomed Inc, Ani Pharms Inc, Aurobindo Pharma, Barr, Carlsbad, Dr Reddys Labs Ltd, Fosun Pharma, 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, and Mylan Pharms Inc, and is included in sixty-three NDAs. There are fifteen 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 forty-six 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:	146
US Patents:	15
Tradenames:	17
Applicants:	45
NDAs:	63
Drug Master File Entries:	34
Suppliers / Packagers:	5
Bulk Api Vendors:	105
Clinical Trials:	240
Patent Applications:	6,983
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

See drug sales revenues for ciprofloxacin

Recent Clinical Trials for ciprofloxacin

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

Sponsor	Phase
National Institute for Health Research, United Kingdom	N/A
University College, London	N/A
Lee's Pharmaceutical Limited	Phase 3

See all ciprofloxacin clinical trials

Generic filers with tentative approvals for CIPROFLOXACIN

Applicant	Application No.	Strength	Dosage Form
		EQ 750MG BASE	TABLET;ORAL
		EQ 500MG BASE	TABLET;ORAL
		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

Quinolone Antimicrobial

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	NDA	Submissiondate
CIPRO	FOR SUSPENSION;ORAL	ciprofloxacin	020780	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
Hikma Farmaceutica	CIPROFLOXACIN	ciprofloxacin	INJECTABLE;INJECTION	076717-001	Dec 22, 2009	AP	RX	No	No
Baxter Hlthcare	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	077888-001	Mar 18, 2008		DISCN	No	No
Ani Pharms Inc	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	075939-003	Jun 9, 2004		DISCN	No	No
Inforlife	CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	078252-001	Mar 18, 2008	AP	RX	No	No
Barr	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	074124-001	Jun 9, 2004		DISCN	No	No

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
Bayer Hlthcare	CIPRO	ciprofloxacin	INJECTABLE;INJECTION	019847-001	Dec 26, 1990
Bayer Hlthcare	CIPRO	ciprofloxacin	FOR SUSPENSION;ORAL	020780-001	Sep 26, 1997
Bayer Hlthcare	CIPRO	ciprofloxacin	FOR SUSPENSION;ORAL	020780-002	Sep 26, 1997
Bayer Pharms	CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019858-001	Dec 26, 1990

International Patents for ciprofloxacin

Country	Patent Number	Estimated Expiration
Chile	2009000956
United Kingdom	0823378
China	102112111
China	102105133
Brazil	PI0910850

Supplementary Protection Certificates for ciprofloxacin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1429780	132013902137451	Italy		PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
1429780	13C0012	France		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		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		PRODUCT NAME: KOMBINATION AUS CIPROFLOXACIN UND DEXAMETHASON, INSBESONDERE CIPROFLOXACINHYDROCHLORID UND DEXAMETHASON; NAT. REGISTRATION NO/DATE: 85150.00. 00 20120830; FIRST REGISTRATION: DAENEMARK 48976 20120808