FLOXIN Drug Patent Profile

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

Floxin is a drug marketed by Ortho Mcneil Pharm, Janssen Pharms, and Daiichi. and is included in three NDAs.

The generic ingredient in FLOXIN is ofloxacin. There are seventy-eight drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Floxin

A generic version of FLOXIN was approved as ofloxacin by LARKEN LABS on September 2^nd, 2003.

Summary for FLOXIN

US Patents:	0
Applicants:	3
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	167
Clinical Trials:	8
Patent Applications:	4,346
DailyMed Link:	FLOXIN at DailyMed

Recent Clinical Trials for FLOXIN

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

Sponsor	Phase
Montefiore Medical Center	Phase 3
Stanford University	Phase 4
Oregon Health and Science University	Phase 4

See all FLOXIN clinical trials

US Patents and Regulatory Information for FLOXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ortho Mcneil Pharm	FLOXIN	ofloxacin	INJECTABLE;INJECTION	020087-002	Mar 31, 1992		DISCN	No	No
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ofloxacin	INJECTABLE;INJECTION	020087-004	Mar 31, 1992		DISCN	No	No
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-002	Dec 28, 1990		DISCN	Yes	No
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ofloxacin	INJECTABLE;INJECTION	020087-005	Mar 31, 1992		DISCN	No	No
Ortho Mcneil Pharm	FLOXIN	ofloxacin	INJECTABLE;INJECTION	020087-003	Mar 31, 1992		DISCN	No	No
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-001	Dec 28, 1990		DISCN	Yes	No

Expired US Patents for FLOXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-002	Dec 28, 1990
Ortho Mcneil Pharm	FLOXIN	ofloxacin	INJECTABLE;INJECTION	020087-002	Mar 31, 1992
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-001	Dec 28, 1990
Ortho Mcneil Pharm	FLOXIN	ofloxacin	INJECTABLE;INJECTION	020087-003	Mar 31, 1992
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-003	Dec 28, 1990

International Patents for FLOXIN

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

Country	Patent Number	Title	Estimated Expiration
Spain	505116
Finland	71155
New Zealand	198224	9-HALO-7-OXO-2,3-DIHYDRO-7H-PYRIDO(1,2,3,-DE)(1,4)BENZOXAZINE-6-CARBOXYLIC ACID DERIVATIVES
Yugoslavia	42422
South Africa	8105604
Denmark	204488

Supplementary Protection Certificates for FLOXIN

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
0206283	C980016	Netherlands		PRODUCT NAME: LEVOFLOXACINE, DESGEWENST IN DE VORM VAN EEN SOLVAAT, IN HET BIJZONDER LEVOFLOXACINE-HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 21810 - RVG 21812 19971209; FIRST REGISTRATION: GB 13402/0011 - 13402/0013 19970606
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
0206283	98C0041	Belgium		PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606
0206283	SPC/GB97/085	United Kingdom		PRODUCT NAME: LEVOFLOXACIN, OPTIONALLY IN THE FORM OF A HEMIHYDRATE; REGISTERED: UK 13402/0011 19970606; UK 13402/0012 19970606; UK 13402/0013 19970606