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Last Updated: November 4, 2024

QUIXIN Drug Patent Profile


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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-eight 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 20th, 2010.

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Summary for QUIXIN
Drug patent expirations by year for QUIXIN
Recent Clinical Trials for QUIXIN

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

SponsorPhase
Roswell Park Cancer InstitutePhase 4
National Cancer Institute (NCI)Phase 4
Children's Oncology GroupPhase 3

See all QUIXIN clinical trials

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for QUIXIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0206283 SPC/GB97/085 United Kingdom ⤷  Sign Up 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 ⤷  Sign Up PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606
0206283 C980016 Netherlands ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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