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Last Updated: March 4, 2021

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LEVAQUIN Drug 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. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has seven patent family members in seven countries.

The generic ingredient in LEVAQUIN is levofloxacin. There are thirty-one drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.

US ANDA Litigation and Generic Entry Outlook for Levaquin

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

  Start Trial

Summary for LEVAQUIN
International Patents:7
US Patents:1
Applicants:1
NDAs:3
Bulk Api Vendors: 83
Clinical Trials: 13
Patent Applications: 4,273
Formulation / Manufacturing:see details
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
National Cancer Institute (NCI)Phase 4
Roswell Park Cancer InstitutePhase 4
Otsuka Pharmaceutical Co., Ltd.Phase 3

See all LEVAQUIN clinical trials

Paragraph IV (Patent) Challenges for LEVAQUIN
Tradename Dosage Ingredient NDA Submissiondate
LEVAQUIN SOLUTION;ORAL levofloxacin 021721 2009-07-30
LEVAQUIN TABLET;ORAL levofloxacin 020634
LEVAQUIN INJECTABLE;INJECTION levofloxacin 020635
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER INJECTABLE;INJECTION levofloxacin 020635

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   Start Trial   Start Trial   Start Trial
Janssen Pharms LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 020635-002 Dec 20, 1996 DISCN Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-001 Dec 20, 1996 DISCN Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 020635-003 Dec 20, 1996 DISCN Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms LEVAQUIN levofloxacin INJECTABLE;INJECTION 020635-004 Dec 20, 1996 DISCN Yes No   Start Trial   Start Trial   Start Trial
>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 TABLET;ORAL 020634-002 Dec 20, 1996   Start Trial   Start Trial
Janssen Pharms LEVAQUIN levofloxacin INJECTABLE;INJECTION 020635-001 Dec 20, 1996   Start Trial   Start Trial
Janssen Pharms LEVAQUIN levofloxacin SOLUTION;ORAL 021721-001 Oct 21, 2004   Start Trial   Start Trial
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-001 Dec 20, 1996   Start Trial   Start Trial
Janssen Pharms LEVAQUIN levofloxacin INJECTABLE;INJECTION 020635-001 Dec 20, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for LEVAQUIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0206283 C980016 Netherlands   Start Trial 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   Start Trial 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   Start Trial PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Express Scripts
Johnson and Johnson

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