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Last Updated: March 1, 2021

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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, Akorn, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Emcure Pharms Ltd, Gland Pharma Ltd, Hospira Inc, Mylan Asi, Zydus Pharms, Fresenius Kabi Usa, Hikma Farmaceutica, Inforlife, Santen, 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, and Zydus Pharms Usa Inc, and is included in forty-seven NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Levofloxacin has seven patent family members in seven countries.

There are thirty-one drug master file entries for levofloxacin. Fifty-three 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
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

Generic filers with tentative approvals for LEVOFLOXACIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial5MG/MLINJECTABLE; INJECTION
  Start Trial  Start Trial750MGTABLET; ORAL
  Start Trial  Start 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 NDA Submissiondate
LEVAQUIN SOLUTION;ORAL levofloxacin 021721 2009-07-30
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER INJECTABLE;INJECTION levofloxacin 020635
QUIXIN SOLUTION/DROPS;OPHTHALMIC levofloxacin 021199
LEVAQUIN TABLET;ORAL levofloxacin 020634
LEVAQUIN INJECTABLE;INJECTION levofloxacin 020635

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
Teva LEVOFLOXACIN levofloxacin TABLET;ORAL 076361-001 Jun 20, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Asi LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 200560-002 Jun 20, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 200674-002 Jun 19, 2013 AP 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

Expired US Patents for levofloxacin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-002 Dec 20, 1996   Start Trial   Start Trial
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-001 Dec 20, 1996   Start Trial   Start Trial
Janssen Pharms LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 020635-005 Dec 20, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for levofloxacin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0206283 98C0041 Belgium   Start Trial PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606
0206283 C980016 Netherlands   Start Trial PRODUCT NAME: LEVOFLOXACINE, DESGEWENST IN DE VORM VAN EEN SOLVAAT, IN HET BIJZONDER LEVOFLOXACINE-HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 21810 - RVG 21812 19971209; FIRST REGISTRATION: GB 13402/0011 - 13402/0013 19970606
0206283 SPC/GB97/085 United Kingdom   Start Trial PRODUCT NAME: LEVOFLOXACIN, OPTIONALLY IN THE FORM OF A HEMIHYDRATE; REGISTERED: UK 13402/0011 19970606; UK 13402/0012 19970606; UK 13402/0013 19970606
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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