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Last Updated: May 24, 2024

Levofloxacin - Generic Drug Details


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What are the generic drug sources for levofloxacin and what is the scope of freedom to operate?

Levofloxacin is the generic ingredient in six branded drugs marketed by Janssen Pharms, Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Gland Pharma Ltd, Hospira, Mylan Asi, Rising, Zydus Pharms, Fresenius Kabi Usa, Hikma Farmaceutica, Inforlife, Knack, Santen, Micro Labs Ltd India, Mylan Labs Ltd, Rubicon, Saptalis Pharms, Watson Labs Teva, Lannett Co Inc, Novitium Pharma, Apotex Inc, Aurobindo Pharma Ltd, Celltrion, Chartwell Molecular, Dr Reddys Labs Inc, Glenmark Pharms Ltd, Hec Pharm, Hetero Labs Ltd V, Jubilant Generics, Lupin, Macleods Pharms Ltd, Mylan, Orbion Pharms, Sandoz, Teva, Torrent Pharms, Watson Labs Inc, and Zydus Lifesciences, and is included in forty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-one drug master file entries for levofloxacin. Forty-six suppliers are listed for this compound. There are four tentative approvals for this compound.

Drug Prices for levofloxacin

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Drug Sales Revenue Trends for levofloxacin

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Recent Clinical Trials for levofloxacin

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SponsorPhase
Yi YangN/A
Melva LouisaPhase 1
Tanta UniversityN/A

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Generic filers with tentative approvals for LEVOFLOXACIN
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up5MG/MLINJECTABLE; INJECTION
⤷  Sign Up⤷  Sign Up500MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up250MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for LEVOFLOXACIN
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 levofloxacin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 078577-001 Aug 12, 2015 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen Pharms LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 020635-005 Dec 20, 1996 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hetero Labs Ltd V LEVOFLOXACIN levofloxacin TABLET;ORAL 202801-002 Jan 8, 2015 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 200674-003 Jun 19, 2013 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Orbion Pharms LEVOFLOXACIN levofloxacin TABLET;ORAL 202200-002 Jan 30, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 078579-003 Sep 3, 2015 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Molecular LEVOFLOXACIN levofloxacin TABLET;ORAL 076890-002 Mar 30, 2012 AB RX No 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 levofloxacin

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

EU/EMA Drug Approvals for levofloxacin

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

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