You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Levofloxacin - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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, 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, 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-three suppliers are listed for this compound. There are four tentative approvals for this compound.

Drug Prices for levofloxacin

See drug prices for levofloxacin

Drug Sales Revenue Trends for levofloxacin

See drug sales revenues for levofloxacin

Recent Clinical Trials for levofloxacin

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

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

See all levofloxacin clinical trials

Generic filers with tentative approvals for LEVOFLOXACIN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial5MG/MLINJECTABLE; INJECTION
⤷  Try a Trial⤷  Try a Trial750MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial500MGTABLET; 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
Orbion Pharms LEVOFLOXACIN levofloxacin TABLET;ORAL 202200-002 Jan 30, 2012 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
Hetero Labs Ltd V LEVOFLOXACIN levofloxacin TABLET;ORAL 202801-003 Jan 8, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 206919-003 Feb 10, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Orbion Pharms LEVOFLOXACIN levofloxacin TABLET;ORAL 202200-001 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

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 ⤷  Try a Trial ⤷  Try a Trial
Santen QUIXIN levofloxacin SOLUTION/DROPS;OPHTHALMIC 021199-001 Aug 18, 2000 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms LEVAQUIN levofloxacin INJECTABLE;INJECTION 020635-001 Dec 20, 1996 ⤷  Try a Trial ⤷  Try a Trial
Santen QUIXIN levofloxacin SOLUTION/DROPS;OPHTHALMIC 021199-001 Aug 18, 2000 ⤷  Try a Trial ⤷  Try a Trial
Santen QUIXIN levofloxacin SOLUTION/DROPS;OPHTHALMIC 021199-001 Aug 18, 2000 ⤷  Try a Trial ⤷  Try a Trial
>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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.