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, Hospira Inc, Mylan Asi, Zydus Pharms, Fresenius Kabi Usa, Hikma Farmaceutica, Inforlife, Santen, Apotex Inc, Micro Labs Ltd India, Mylan Labs Ltd, Rising, 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. Fifty-three suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for levofloxacin

International Patents:	7
US Patents:	1
Tradenames:	6
Applicants:	35
NDAs:	45
Drug Master File Entries:	31
Suppliers / Packagers:	53
Bulk Api Vendors:	80
Clinical Trials:	222
Patent Applications:	6,735
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for levofloxacin
Drug Sales Revenues:	Drug sales revenues for levofloxacin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for levofloxacin
DailyMed Link:	levofloxacin at DailyMed

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

Sponsor	Phase
KRKA	N/A
Slovenian Society for Gastroenterology and Hepatology	N/A
Novartis Pharmaceuticals	Phase 3

See all levofloxacin clinical trials

Recent Litigation for levofloxacin

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Senju Pharmaceutical Co. v. Lupin Limited	2013-09-10
Senju Pharmaceutical Co. Ltd. v. Apotex Inc.	2012-02-10
Senju Pharmaceutical Co. Ltd. v. Lupin Limited	2011-03-31

See all levofloxacin litigation

Generic filers with tentative approvals for LEVOFLOXACIN

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	5MG/ML	INJECTABLE; INJECTION
Start Trial	Start Trial	750MG	TABLET; ORAL
Start Trial	Start Trial	500MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for levofloxacin

Anti-Bacterial Agents
Anti-Infective Agents, Urinary
Cytochrome P-450 CYP1A2 Inhibitors
Topoisomerase II Inhibitors

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
(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-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-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
Aeroquin
AK163316
AKOS008901361
AKOS015895104
Anhydrous Ofloxacin
API0007780
AS-31796
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 hydrate
Cravit IV
CS-2218
D08120
DB01137
DE-108
DR-3355
DR-3355: L-isomer of ofloxacin
DR3355
DTXSID0041060
EBD8264
Elequine
EX-A1488
Floxacin
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
Iquix hydrate
KBio2_002199
KBio2_004767
KBio2_007335
KBio3_001909
KBioGR_001605
KBioSS_002199
L-Ofloxacin
L0193
Levaquin
Levaquin (TN)
Levaquin hydrate
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Levo Floxacin
Levofiexacin
Levofloxacin (INN)
Levofloxacin (Levaquin)
Levofloxacin [USAN:INN:JAN]
Levofloxacin Anhydrous
Levofloxacin hydrate
Levofloxacin solution, 1.0 mg/mL in acetonitrile, certified reference material
Levofloxacin tablet, suspension or intravenous
levofloxacin-levaquin
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]
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
MP 376
MP-376
NC00094
NCGC00178529-01
NCGC00178529-03
NSC-758709
NSC758709
Ofloxacin S-(-)-form
Ofloxacin s-(-)-form hemihydrate
Ofloxcacin
Oftaquix
Pharmakon1600-01504260
Q-201295
Q424193
Quixin
RIX4E89Y14
RWJ 25213-097
RWJ-25213
S-(-)-Ofloxacin
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
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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	LEVOFLOXACIN	levofloxacin	TABLET;ORAL	201043-001	Jun 20, 2011	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Hikma Farmaceutica	LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER	levofloxacin	INJECTABLE;INJECTION	091375-002	Sep 16, 2011	AP	RX	No	No	Start Trial	Start Trial				Start Trial
Dr Reddys Labs Inc	LEVOFLOXACIN	levofloxacin	TABLET;ORAL	076710-001	Jun 20, 2011	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Akorn	LEVOFLOXACIN	levofloxacin	INJECTABLE;INJECTION	091644-001	Jun 20, 2011	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000	Start Trial	Start Trial
Janssen Pharms	LEVAQUIN	levofloxacin	INJECTABLE;INJECTION	020635-004	Dec 20, 1996	Start Trial	Start Trial
Janssen Pharms	LEVAQUIN	levofloxacin	INJECTABLE;INJECTION	020635-001	Dec 20, 1996	Start Trial	Start Trial
Santen	QUIXIN	levofloxacin	SOLUTION/DROPS;OPHTHALMIC	021199-001	Aug 18, 2000	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for levofloxacin

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Country	Patent Number	Estimated Expiration
Malaysia	129406	Start Trial
Mexico	PA03008056	Start Trial
Canada	2440412	Start Trial
Japan	2004535370	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for levofloxacin

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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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