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Last Updated: April 14, 2021

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LEVOFLOXACIN Drug Profile

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Which patents cover Levofloxacin, and when can generic versions of Levofloxacin launch?

Levofloxacin is a drug marketed by Akorn, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Emcure Pharms Ltd, Gland Pharma Ltd, Hospira Inc, Mylan Asi, Zydus Pharms, Micro Labs Ltd India, Mylan Labs Ltd, Rising, Rubicon, Watson Labs Teva, Lannett Co Inc, Apotex Inc, Celltrion, Cipla Ltd, Dr Reddys Labs Inc, Glenmark Generics, Hec Pharm, Hetero Labs Ltd V, Jubilant Generics, Lupin, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Sandoz, Teva, Torrent Pharms, Watson Labs Inc, Zydus Pharms Usa Inc, Fresenius Kabi Usa, Hikma Farmaceutica, and Inforlife. and is included in forty-two NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Levofloxacin

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

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Drug patent expirations by year for LEVOFLOXACIN
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
Shaheed Benazir Bhutto University Sheringal Dir UpperPhase 1
PolyActiva Pty LtdPhase 1
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityN/A

See all LEVOFLOXACIN clinical trials

Paragraph IV (Patent) Challenges for LEVOFLOXACIN
Tradename Dosage Ingredient NDA Submissiondate
LEVAQUIN SOLUTION;ORAL levofloxacin 021721 2009-07-30
LEVAQUIN INJECTABLE;INJECTION levofloxacin 020635
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER INJECTABLE;INJECTION levofloxacin 020635
QUIXIN SOLUTION/DROPS;OPHTHALMIC levofloxacin 021199
LEVAQUIN TABLET;ORAL levofloxacin 020634

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
Watson Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 201484-002 Nov 22, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Glenmark Generics LEVOFLOXACIN levofloxacin TABLET;ORAL 200250-003 Jun 20, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Celltrion LEVOFLOXACIN levofloxacin TABLET;ORAL 090367-003 Jun 20, 2011 AB RX No 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

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