CILOXAN Drug Patent Profile

When do Ciloxan patents expire, and what generic alternatives are available?

Ciloxan is a drug marketed by Sandoz and is included in two NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ciloxan

A generic version of CILOXAN was approved as ciprofloxacin hydrochloride by RUBICON on June 9^th, 2004.

Summary for CILOXAN

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	6
Patent Applications:	3,288
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CILOXAN
Drug Sales Revenues:	Drug sales revenues for CILOXAN
What excipients (inactive ingredients) are in CILOXAN?	CILOXAN excipients list
DailyMed Link:	CILOXAN at DailyMed

See drug prices for CILOXAN

See drug sales revenues for CILOXAN

Recent Clinical Trials for CILOXAN

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

Sponsor	Phase
National University of Malaysia	Phase 1/Phase 2
Santen Pharmaceutical Co., Ltd.	Phase 1/Phase 2
CR-CSSS Champlain-Charles-Le Moyne	Phase 3

See all CILOXAN clinical trials

Pharmacology for CILOXAN

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

Anatomical Therapeutic Chemical (ATC) Classes for CILOXAN

J01MA	Fluoroquinolones
J01M	QUINOLONE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J01MA	Fluoroquinolones
J01M	QUINOLONE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S03AA	Antiinfectives
S03A	ANTIINFECTIVES
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

US Patents and Regulatory Information for CILOXAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	CILOXAN	ciprofloxacin hydrochloride	OINTMENT;OPHTHALMIC	020369-001	Mar 30, 1998		RX	Yes	Yes
Sandoz	CILOXAN	ciprofloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019992-001	Dec 31, 1990	AT	RX	Yes	Yes

Expired US Patents for CILOXAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	CILOXAN	ciprofloxacin hydrochloride	OINTMENT;OPHTHALMIC	020369-001	Mar 30, 1998
Sandoz	CILOXAN	ciprofloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019992-001	Dec 31, 1990

International Patents for CILOXAN

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

Country	Patent Number	Title	Estimated Expiration
Finland	885278
South Africa	8204829
Japan	S6362510
Denmark	306082

Supplementary Protection Certificates for CILOXAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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