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Last Updated: November 21, 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, Norvium Bioscience, Rising, Zydus Pharms, Fresenius Kabi Usa, Hikma Farmaceutica, Inforlife, Knack, Santen, Micro Labs Ltd India, Rubicon, Sciegen Pharms Inc, Watson Labs Teva, Lannett Co Inc, Novitium Pharma, Anda Repository, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Molecular, Dr Reddys Labs Inc, Glenmark Pharms Ltd, Hec Pharm, Hetero Labs Ltd V, Jubilant Generics, Lupin, Macleods Pharms Ltd, Natco Pharma, 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-eight 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

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

SponsorPhase
Beijing Chest HospitalPhase 3
National Medical Center for Infectious DiseasesPhase 3
Erasmus Medical CenterPhase 4

See all levofloxacin clinical trials

Generic filers with tentative approvals for LEVOFLOXACIN
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up5MG/MLINJECTABLE; INJECTION
⤷  Sign Up⤷  Sign Up750MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up500MGTABLET; 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
Eugia Pharma LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 202328-002 Jan 24, 2013 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glenmark Pharms Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 200250-003 Jun 20, 2011 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Knack LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 216164-002 Jan 29, 2024 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Macleods Pharms Ltd LEVOFLOXACIN levofloxacin TABLET;ORAL 200839-003 Mar 22, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Knack LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 216164-001 Jan 29, 2024 DISCN 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 levofloxacin TABLET;ORAL 020634-001 Dec 20, 1996 ⤷  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
Janssen Pharms LEVAQUIN levofloxacin INJECTABLE;INJECTION 020635-001 Dec 20, 1996 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-003 Sep 8, 2000 ⤷  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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