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 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 LARKEN LABS 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
Oregon Health and Science University	Phase 4
University of California, San Francisco	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
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

Supplementary Protection Certificates for FLOXIN IN DEXTROSE 5%

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