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Last Updated: November 21, 2024

LEVAQUIN Drug Patent Profile


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When do Levaquin patents expire, and what generic alternatives are available?

Levaquin is a drug marketed by Janssen Pharms and is included in three NDAs.

The generic ingredient in LEVAQUIN 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 Levaquin

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

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Summary for LEVAQUIN
US Patents:0
Applicants:1
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 98
Clinical Trials: 24
Patent Applications: 5,337
Drug Prices: Drug price information for LEVAQUIN
What excipients (inactive ingredients) are in LEVAQUIN?LEVAQUIN excipients list
DailyMed Link:LEVAQUIN at DailyMed
Drug patent expirations by year for LEVAQUIN
Drug Prices for LEVAQUIN

See drug prices for LEVAQUIN

Drug Sales Revenue Trends for LEVAQUIN

See drug sales revenues for LEVAQUIN

Recent Clinical Trials for LEVAQUIN

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

SponsorPhase
Indonesia UniversityPhase 1/Phase 2
PfizerPhase 2
National Lung Hospital, VietnamPhase 2

See all LEVAQUIN clinical trials

Paragraph IV (Patent) Challenges for LEVAQUIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LEVAQUIN Oral Solution levofloxacin 25 mg/mL 021721 1 2009-07-30

US Patents and Regulatory Information for LEVAQUIN

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 levofloxacin INJECTABLE;INJECTION 020635-001 Dec 20, 1996 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Pharms LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 020635-002 Dec 20, 1996 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-001 Dec 20, 1996 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Pharms LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 020635-003 Dec 20, 1996 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Pharms LEVAQUIN levofloxacin INJECTABLE;INJECTION 020635-004 Dec 20, 1996 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 LEVAQUIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms LEVAQUIN levofloxacin INJECTABLE;INJECTION 020635-001 Dec 20, 1996 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms LEVAQUIN levofloxacin SOLUTION;ORAL 021721-001 Oct 21, 2004 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms LEVAQUIN levofloxacin SOLUTION;ORAL 021721-001 Oct 21, 2004 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-002 Dec 20, 1996 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-001 Dec 20, 1996 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for LEVAQUIN

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 LEVAQUIN

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

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