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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Levofloxacin - Generic Drug Details

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What are the generic sources for levofloxacin and what is the scope of patent protection?

Levofloxacin is the generic ingredient in six branded drugs marketed by Janssen Pharms, Akorn, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Emcure Pharms Ltd, Hospira Inc, Mylan Asi, Zydus Pharms, Fresenius Kabi Usa, Hikma Farmaceutica, Inforlife, Santen, Anda Repository, Apotex Inc, Micro Labs Ltd India, Mylan Labs Ltd, Watson Labs Teva, Hi Tech Pharma, Lannett Co 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-five 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. Sixty 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
Novartis PharmaceuticalsPhase 3
Otsuka Pharmaceutical Co., Ltd.Phase 3
United States Department of DefensePhase 3

See all levofloxacin clinical trials

Recent Litigation for levofloxacin

Identify potential future generic entrants

District Court Litigation
Case NameDate
Senju Pharmaceutical Co. v. Lupin Limited2013-09-10
Senju Pharmaceutical Co. Ltd. v. Apotex Inc.2012-02-10
Senju Pharmaceutical Co. Ltd. v. Lupin Limited2011-03-31

See all levofloxacin litigation

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.

Synonyms for levofloxacin
(-)-(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid
(-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyridol[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate
(-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7Hpyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate
(-)-Ofloxacin
(-)-Ofloxacin; (-)-(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazin-yl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid
()-(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1;()-(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1
(2S)-7-fluoro-2-methyl-6-(4-methylpiperazin-1-yl)-10-oxo-4-oxa-1-azatricyclo[7.3.1.0^{5,13}]trideca-5(13),6,8,11-tetraene-11-carboxylic acid
(2S)-7-fluoro-2-methyl-6-(4-methylpiperazin-1-yl)-10-oxo-4-oxa-1-azatricyclo[7.3.1.0;{5,13}]trideca-5(13),6,8,11-tetraene-11-carboxylic acid
(3S)-(-)-9-Fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid
(3s)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7h-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid
(3S)-9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid
(R)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid
(R)-isomer
(S)-(-)-9-fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzooxazine-6-carboxylic acid
(S)-(-)-Ofloxacin
(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid
(S)-9-fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]-benzoxazine-6-carboxylic acid
(S)-9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid
(S)-Ofloxacin
100986-85-4
7H-Pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid, 2,3-dihydro-9-fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-, (S)-
7H-Pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid, 2,3-dihydro-9-fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-, hemihydrate, (S)-
7H-Pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, 9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-, (3S)-
986L854
AB00171657_14
AB00171657_15
AB00171657-12
AB00171657-13
AB0072147
AB1009501
AC-7593
AC1L3YF8
Aeroquin
AJ-23383
AK163316
AKOS008901361
AKOS015895104
AN-8873
API0007780
AS-31796
BCP22048
BDBM50366826
BG0235
BIL1009
BRD-K09471561-001-06-7
BSPBio_002689
C07660
C18H20FN3O4
C18H20FN3O4.H2O
CCG-39093
CCRIS 4073
CCRIS 4074
CHEBI:63598
CPD000466387
Cravit
Cravit (TN)
Cravit IV
Cravit Ophthalmic
CS-2218
D08120
DB01137
DE-108
DR-3355
DR-3355: L-isomer of ofloxacin
DR3355
DRG-0129
DTXSID0041060
EBD8264
Elequine
EX-A1488
Floxacin
Floxel
fluoro-methyl-(4-methylpiperazin-1-yl)-oxo-[?]carboxylic acid
FT-0627808
GSDSWSVVBLHKDQ-JTQLQIEISA-N
HMS1922J07
HMS2051G04
HMS2090O10
HMS2093E18
HMS2232G06
HR 355
HR-355
HSDB 8028
HY-B0330
Iquix
KBio2_002199
KBio2_004767
KBio2_007335
KBio3_001909
KBioGR_001605
KBioSS_002199
L-Ofloxacin
L0193
Leroxacin
Lesacin
Levaquin
Levaquin (TN)
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Levo Floxacin
Levofiexacin
Levofloxacin (INN)
Levofloxacin (Levaquin)
Levofloxacin [USAN:INN:JAN]
Levofloxacin hydrate
Levofloxacin solution, 1.0 mg/mL in acetonitrile, certified reference material
Levofloxacin tablet, suspension or intravenous
Levofloxacin, >=98.0% (HPLC)
Levofloxacin, analytical reference material
Levofloxacin, Antibiotic for Culture Media Use Only
Levofloxacin,(S)
Levofloxacine
Levofloxacine [INN-French]
Levofloxacino
Levofloxacino [INN-Spanish]
Levofloxacinum
Levofloxacinum [INN-Latin]
Levokacin
Levox
Levoxacin
LFX
Loxof
LS-133260
LS-171761
LVFX; RWJ 25213; L-Ofloxacin; Ophthalmic; (-)-(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazin-yl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid
LVX
MCULE-2011834955
MLS000759524
MLS001165709
MLS001423977
MMV687798
MolPort-002-885-835
Mosardal
MP 376
MP-376
NC00094
NCGC00178529-01
NCGC00178529-03
Nofaxin
NSC-758709
NSC758709
Ofloxacin S-(-)-form
Oftaquix
Pharmakon1600-01504260
Q-201295
Quixin
Reskuin
RIX4E89Y14
RWJ 25213-097
RWJ-25213
S-(-)-Ofloxacin
s1940
SAM001246758
SBI-0206768.P001
SCHEMBL15397
SMR000466387
SPBio_001891
Spectrum_001719
SPECTRUM1504260
Spectrum2_001676
Spectrum3_000995
Spectrum4_001123
Spectrum5_001438
SR-05000001999
SR-05000001999-1
ST24047487
Tavanic
Unibiotic
UNII-A4P49JAZ9H component GSDSWSVVBLHKDQ-JTQLQIEISA-N
UNII-RIX4E89Y14
Venaxan
Volequin
Z1766089137
ZINC538273
ZX-AFC000651
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
Zydus Pharms LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 205968-002 Jun 1, 2017 DISCN No No   Start Trial   Start Trial   Start Trial
Hec Pharm LEVOFLOXACIN levofloxacin TABLET;ORAL 204968-003 Feb 5, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Baxter Hlthcare Corp LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 091397-001 Aug 8, 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 020634-001 Dec 20, 1996   Start Trial   Start Trial
Santen QUIXIN levofloxacin SOLUTION/DROPS;OPHTHALMIC 021199-001 Aug 18, 2000   Start Trial   Start Trial
Santen QUIXIN levofloxacin SOLUTION/DROPS;OPHTHALMIC 021199-001 Aug 18, 2000   Start Trial   Start Trial
Janssen Pharms LEVAQUIN levofloxacin INJECTABLE;INJECTION 020635-001 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 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 98C0041 Belgium   Start Trial PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 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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Express Scripts
Medtronic
Johnson and Johnson
McKesson
Dow
Merck

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