LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Levaquin In Dextrose 5% In Plastic Container, and when can generic versions of Levaquin In Dextrose 5% In Plastic Container launch?

Levaquin In Dextrose 5% In Plastic Container is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER is levofloxacin. There are thirty-one drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Levaquin In Dextrose 5% In Plastic Container

A generic version of LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER was approved as levofloxacin by RISING on December 20^th, 2010.

Summary for LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	23
Formulation / Manufacturing:	see details
DailyMed Link:	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

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

Sponsor	Phase
Harvard Medical School	Phase 2
University of California, San Francisco	Phase 2
Otsuka Pharmaceutical Co., Ltd.	Phase 2

See all LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

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

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-002	Dec 20, 1996		DISCN	Yes	No
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-003	Dec 20, 1996		DISCN	Yes	No
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-005	Dec 20, 1996		DISCN	Yes	No

Expired US Patents for LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-003	Dec 20, 1996
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-003	Dec 20, 1996
Janssen Pharms	LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	020635-002	Dec 20, 1996

EU/EMA Drug Approvals for LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Chiesi Farmaceutici S.p.A	Quinsair	levofloxacin	EMEA/H/C/002789 Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis.Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	no	no	no	2015-03-25

International Patents for LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

See the table below for patents covering LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	285086
Japan	S6111955
Denmark	158267

Supplementary Protection Certificates for LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
0206283	98C0041	Belgium		PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606