QUIXIN Drug Patent Profile

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

Quixin is a drug marketed by Santen and is included in one NDA.

The generic ingredient in QUIXIN 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 Quixin

A generic version of QUIXIN was approved as levofloxacin by RISING on December 20^th, 2010.

Summary for QUIXIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	2
Patent Applications:	4,371
Formulation / Manufacturing:	see details
DailyMed Link:	QUIXIN at DailyMed

Recent Clinical Trials for QUIXIN

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

Sponsor	Phase
Roswell Park Cancer Institute	Phase 4
National Cancer Institute (NCI)	Phase 4
Children's Oncology Group	Phase 3

See all QUIXIN clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for QUIXIN

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 QUIXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000		DISCN	Yes	No

Expired US Patents for QUIXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000

EU/EMA Drug Approvals for QUIXIN

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 QUIXIN

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

Country	Patent Number	Title	Estimated Expiration
New Zealand	198224	9-HALO-7-OXO-2,3-DIHYDRO-7H-PYRIDO(1,2,3,-DE)(1,4)BENZOXAZINE-6-CARBOXYLIC ACID DERIVATIVES
Finland	862643
Yugoslavia	45512
Japan	S5746986	PYRIDO(1,2,3-DE)(1,4)BENZOXAZINE DERIVATIVE
Yugoslavia	74788
Spain	8301977
Japan	S60123420	USE OF NORFLOXACIN AND RELATED ANTIBIOTICS FOR EYE

Supplementary Protection Certificates for QUIXIN

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