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Last Updated: March 28, 2024

LEVOFLOXACIN Drug Patent Profile


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

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

The generic ingredient in LEVOFLOXACIN is levofloxacin. There are thirty-one drug master file entries for this compound. Forty-three 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 RISING on December 20th, 2010.

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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
Watson Labs Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 201484-002 Nov 22, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Generics LEVOFLOXACIN levofloxacin TABLET;ORAL 200250-003 Jun 20, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Celltrion LEVOFLOXACIN levofloxacin TABLET;ORAL 090367-003 Jun 20, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gland Pharma Ltd LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 206908-001 Dec 30, 2020 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Jubilant Generics LEVOFLOXACIN levofloxacin TABLET;ORAL 203613-002 Jun 19, 2015 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Orbion Pharms LEVOFLOXACIN levofloxacin TABLET;ORAL 202200-002 Jan 30, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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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