Ciprofloxacin - Generic Drug Details

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.

Summary for ciprofloxacin

International Patents:	152
US Patents:	13
Tradenames:	17
Applicants:	48
NDAs:	64
Drug Master File Entries:	34
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	120
Clinical Trials:	288
Patent Applications:	7,011
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
University Hospital of Split	Phase 4
Lund University	Phase 3
Columbia University	Phase 4

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	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
Taro	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	076912-001	Feb 18, 2005	AB	RX	No	No
Novartis	CIPRODEX	ciprofloxacin; dexamethasone	SUSPENSION/DROPS;OTIC	021537-001	Jul 18, 2003	AB	RX	Yes	Yes			Y
Rising	CIPROFLOXACIN HYDROCHLORIDE	ciprofloxacin hydrochloride	TABLET;ORAL	075817-004	Jun 9, 2004		DISCN	No	No

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
Bayer Hlthcare	CIPRO	ciprofloxacin	INJECTABLE;INJECTION	019847-001	Dec 26, 1990
Bayer Hlthcare	CIPRO	ciprofloxacin	INJECTABLE;INJECTION	019847-001	Dec 26, 1990
Bayer Hlthcare	CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER	ciprofloxacin	INJECTABLE;INJECTION	019857-001	Dec 26, 1990

International Patents for ciprofloxacin

Country	Patent Number	Title	Estimated Expiration
Japan	6147653
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)
Mexico	2010011545	FORMULACIONES PARA TRATAR ENFERMEDADES Y AFECCIONES DEL OIDO. (AURIS FORMULATIONS FOR TREATING OTIC DISEASES AND CONDITIONS.)
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)

Supplementary Protection Certificates for ciprofloxacin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
1429780	132013902137451	Italy		PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
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