FLOXIN IN DEXTROSE 5% Drug Patent Profile

Which patents cover Floxin In Dextrose 5%, and what generic alternatives are available?

Floxin In Dextrose 5% is a drug marketed by Ortho Mcneil Pharm and is included in one NDA.

The generic ingredient in FLOXIN IN DEXTROSE 5% is ofloxacin. There are seventy-eight drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Floxin In Dextrose 5%

A generic version of FLOXIN IN DEXTROSE 5% was approved as ofloxacin by CHARTWELL RX on September 2^nd, 2003.

Summary for FLOXIN IN DEXTROSE 5%

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	8
DailyMed Link:	FLOXIN IN DEXTROSE 5% at DailyMed

Recent Clinical Trials for FLOXIN IN DEXTROSE 5%

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

Sponsor	Phase
Montefiore Medical Center	Phase 3
University of California, San Francisco	Phase 4
Winston Chamberlain, MD, PhD	Phase 4

See all FLOXIN IN DEXTROSE 5% clinical trials

US Patents and Regulatory Information for FLOXIN IN DEXTROSE 5%

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 IN DEXTROSE 5%	ofloxacin	INJECTABLE;INJECTION	020087-001	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
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ofloxacin	INJECTABLE;INJECTION	020087-005	Mar 31, 1992		DISCN	No	No

Expired US Patents for FLOXIN IN DEXTROSE 5%

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5%	ofloxacin	INJECTABLE;INJECTION	020087-001	Mar 31, 1992

International Patents for FLOXIN IN DEXTROSE 5%

See the table below for patents covering FLOXIN IN DEXTROSE 5% around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	388981
Yugoslavia	47193
Malaysia	8600712	BENZOXALINE DERIVATIVES
South Korea	840002141
South Korea	830006303
Finland	812693
Bosnia and Herzegovina	97190

Supplementary Protection Certificates for FLOXIN IN DEXTROSE 5%

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0413455	98C0040	Belgium		PRODUCT NAME: ALATROFLOXACIN; NAT. REGISTRATION NO/DATE: EU/1/98/060/001 19980327; FIRST REGISTRATION: CH 54484 19980327
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
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
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
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