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Generated: April 25, 2019

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Levofloxacin - Generic Drug Details

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What are the generic sources for levofloxacin and what is the scope of levofloxacin 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 Usa Inc, Fresenius Kabi Usa, Hikma Farmaceutica, Inforlife, Santen, Apotex Inc, Micro Labs Ltd India, Mylan Labs Ltd, Rising Pharms, Watson Labs Teva, Hi Tech Pharma, Lannett Co Inc, 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 Wockhardt, 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. Seventy-two suppliers are listed for this compound. There are four tentative approvals for this compound.

Pharmacology for levofloxacin
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
Tentative approvals for LEVOFLOXACIN
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial5MG/MLINJECTABLE; INJECTION
➤ Try a Free Trial➤ Try a Free Trial750MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial500MGTABLET; ORAL

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
Apotex Inc LEVOFLOXACIN levofloxacin TABLET;ORAL 090787-001 Sep 29, 2011 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Orchid Hlthcare LEVOFLOXACIN levofloxacin TABLET;ORAL 202200-002 Jan 30, 2012 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Hospira Inc LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 078579-001 Sep 3, 2015 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 200674-002 Jun 19, 2013 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Hospira Inc LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 078577-001 Aug 12, 2015 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Akorn LEVOFLOXACIN levofloxacin INJECTABLE;INJECTION 091644-002 Jun 20, 2011 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Rising Pharms LEVOFLOXACIN levofloxacin SOLUTION/DROPS;OPHTHALMIC 077700-001 Dec 20, 2010 AT RX No Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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Expired US Patents for levofloxacin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santen IQUIX levofloxacin SOLUTION/DROPS;OPHTHALMIC 021571-001 Mar 1, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 020635-003 Dec 20, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms LEVAQUIN levofloxacin INJECTABLE;INJECTION 020635-004 Dec 20, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms LEVAQUIN levofloxacin TABLET;ORAL 020634-001 Dec 20, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 020635-002 Dec 20, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms LEVAQUIN levofloxacin INJECTABLE;INJECTION 020635-001 Dec 20, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER levofloxacin INJECTABLE;INJECTION 020635-005 Dec 20, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for levofloxacin

Supplementary Protection Certificates for levofloxacin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0206283 C980016 Netherlands ➤ Try a Free 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 ➤ Try a Free Trial PRODUCT NAME: LEVOFLOXACIN, OPTIONALLY IN THE FORM OF A HEMIHYDRATE; REGISTERED: UK 13402/0011 19970606; UK 13402/0012 19970606; UK 13402/0013 19970606
0206283 98C0041 Belgium ➤ Try a Free Trial PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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