Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

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OFLOXACIN - Generic Drug Details

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

Ofloxacin is the generic ingredient in six branded drugs marketed by Ortho Mcneil Pharm, Bedford, Allergan, Akorn, Altaire Pharms Inc, Alvogen, Apotex Inc, Bausch And Lomb, Fdc Ltd, Hi Tech Pharma, Sandoz, Sandoz Inc, Daiichi, Amneal Pharms Co, Janssen Pharms, Cadila Pharms Ltd, Dr Reddys Labs Ltd, Larken Labs, Ranbaxy Labs Ltd, and Teva, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are seventy-eight drug master file entries for ofloxacin. Twenty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for OFLOXACIN

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Drug Sales Revenue Trends for OFLOXACIN

See drug sales revenues for OFLOXACIN

Recent Clinical Trials for OFLOXACIN

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

SponsorPhase
Montefiore Medical CenterPhase 3
Sir Mortimer B. Davis - Jewish General HospitalPhase 2
Cancer Research NetworkPhase 2

See all OFLOXACIN clinical trials

Recent Litigation for OFLOXACIN

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 OFLOXACIN litigation

Generic filers with tentative approvals for OFLOXACIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial400MGTABLET;ORAL
  Start Trial  Start Trial300MGTABLET;ORAL
  Start Trial  Start Trial200MGTABLET;ORAL

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

Pharmacology for OFLOXACIN
Synonyms for OFLOXACIN
( -)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)(1,4)benzoxazin-6-carbonsaeure
()-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoazine-6-carboxylic acid
(+-)-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
(+-)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)(1,4)benzoxazin-6-carbonsaeure
(+/-)-9-Fluoro-2,2,3-de)-1,4-benzoxazine-6-carboxylic acid
(+/-)-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
(+/-)-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
(+/-)-Floxin
(3R)-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
118120-51-7 (hydrochloride)
138199-71-0 (0.5H2O)
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
7-fluoro-2-methyl-6-(4-methylpiperazin-1-yl)-10-oxo-4-oxa-1-azatricyclo[7.3.1.0,(1)(3)]trideca-5(13),6,8,11-tetraene-11-carboxylic acid
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
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-, (+-)-
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-
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-, (+-)-
8-Fluoro-3-methyl-9-(4-methyl-piperazin-1-yl)-6-oxo-2,3-dihydro-6H-1-oxa-3a-aza-phenalene-5-carboxylic acid
82419-36-1
83380-47-6
85344-55-4
86O854
9-Fluoro-10-(4-methylpiperazino)-3-methyl-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de]-1,4-benzooxazine-6-carboxylic acid
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
9-Fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-pyrido [1,2,3-de]-1,4-Benzoxazin-6-carboxylic Acid
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
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
9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-3,7-dihydro-2H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid
9-fluoro-3-methyl-10-(4-methylpiperazino)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid
9-Fluoro-3,7-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic Acid
AB00052263_14
AB00052263_15
AB00052263-12
AB00052263-13
AB0013254
AB00513820
AB1009384
AC-7616
AC1L1IHM
ACMC-20m40v
AK163167
AKOS001033517
AKOS016042783
AN-8832
Bactocin
BBL005605
BCP14346
BCP9000851
BDBM50045004
BPBio1_000345
BRD-A24228527-001-05-9
BRD-A24228527-001-19-0
BRN 3657947
BSPBio_000313
BSPBio_003117
C07321
C18H20FN3O4
CAS-82419-36-1
CCG-39210
CCRIS 5233
CHEBI:7731
CHEMBL4
CPD000058192
CS-1891
D00453
Danoflox
DB01165
DivK1c_000721
DL 8280
DL-8280
DSSTox_CID_21085
DSSTox_GSID_41085
DSSTox_RID_79623
DTXSID3041085
EBD13209
Effexin
Epitope ID:116889
EU-0100904
Exocin
Exocine
F0020-0095
F0472-0226
Flobacin
Flodemex
Flotavid
Flovid
Floxal
Floxil
Floxin
Floxin (TN)
FLOXIN IN DEXTROSE 5%
FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Floxin otic
Floxstat
fluoro-methyl-(4-methylpiperazin-1-yl)-oxo-[?]carboxylic acid
FT-0630905
Fugacin
GSDSWSVVBLHKDQ-UHFFFAOYSA-N
H778
HMS1568P15
HMS1921H12
HMS2090F07
HMS2092B10
HMS2095P15
HMS2235C05
HMS3259G07
HMS3262F10
HMS3369B01
HMS3393K06
HMS3604B17
HMS3712P15
HMS502E03
HOE 280
Hoe-280
HSDB 8030
HY-B0125
I06-0112
I06-0380
IDI1_000721
Inoflox
J10376
KBio1_000721
KBio2_001666
KBio2_004234
KBio2_006802
KBio3_002617
KBioGR_000667
KBioSS_001666
Kinflocin
Kinoxacin
KS-00000UJW
KS-5011
LEVOFLOXACIN HCL
Liflox
Lopac0_000904
Loxinter
LP00904
LS-133259
Marfloxacin
Medofloxine
Mergexin
MFCD00226105
MFCD00865049
MLS000028749
MLS001074203
MLS006011774
MolPort-000-422-241
Monoflocet
NC00466
NCGC00015772-02
NCGC00015772-03
NCGC00015772-04
NCGC00015772-05
NCGC00015772-06
NCGC00015772-07
NCGC00015772-08
NCGC00015772-09
NCGC00015772-10
NCGC00015772-12
NCGC00015772-13
NCGC00016948-01
NCGC00094219-01
NCGC00094219-02
NCGC00094219-03
NCGC00094219-04
NCGC00094219-05
NCGC00094219-06
NCGC00178284-01
NCGC00178284-02
NCGC00261589-01
NINDS_000721
Novecin
NSC-727071
NSC-758178
NSC727071
NSC758178
Nufafloqo
O 8757
O-2800
O-Flox
O0403
Obide
Occidal
Ocuflox
Ofcin
Oflin
Oflocee
Oflocet
Oflocin
Oflodal
Oflodex
Oflodura
Oflox
Ofloxacin (Floxin)
Ofloxacin (JP17/USP/INN)
Ofloxacin [USAN:BAN:INN:JAN]
Ofloxacin [USAN:USP:INN:BAN:JAN]
Ofloxacin Otic
Ofloxacin, (S)-Isomer
Ofloxacin, 98%
Ofloxacin, Antibiotic for Culture Media Use Only
Ofloxacin, European Pharmacopoeia (EP) Reference Standard
Ofloxacin, fluoroquinolone antibiotic
Ofloxacin, Pharmaceutical Secondary Standard; Certified Reference Material
Ofloxacin, United States Pharmacopeia (USP) Reference Standard
Ofloxacin, VETRANAL(TM), analytical standard
Ofloxacin,(S)
ofloxacin;
Ofloxacina
Ofloxacina [DCIT]
Ofloxacine
Ofloxacine [French]
Ofloxacine; DL-8280; HOE-280
Ofloxacino
Ofloxacino [Spanish]
Ofloxacinum
Ofloxacinum [Latin]
Ofloxin
OFLX
Ofus
OFX
Onexacin
Opera_ID_1114
Operan
Oprea1_242882
ORF 18489
ORF-28489
Orocin
Otonil
Oxaldin
Pharflox
Pharmakon1600-01502044
Praxin
Prestwick0_000237
Prestwick1_000237
Prestwick2_000237
Prestwick3_000237
PT 01
Puiritol
Qinolon
Qipro
Quinolon
Quotavil
Rilox
RKL10083
Ru-43280
s1463
SAM002264629
SBI-0050879.P003
SC-12664
SC-17360
SCHEMBL14163982
SCHEMBL24373
Sinflo
SMR000058192
SPBio_001387
SPBio_002234
Spectrum_001186
SPECTRUM1502044
Spectrum2_001464
Spectrum3_001499
Spectrum4_000324
Spectrum5_001063
SR-01000076050
SR-01000076050-1
SR-01000076050-4
SR-01000076050-7
ST073364
ST24048838
STK256723
Tabrin
Taravid
Tariflox
Tarivid
Telbit
Tox21_110703
Tox21_110703_1
Tox21_500904
Tructum
Uro Tarivid
VA11432
Viotisone
Visiren
VU0243192-7
W-3058
WP-0405
Z56761309
Zanocin
Paragraph IV (Patent) Challenges for OFLOXACIN
Tradename Dosage Ingredient NDA Submissiondate
FLOXIN OTIC SOLUTION/DROPS;OTIC ofloxacin 020799

US Patents and Regulatory Information for OFLOXACIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 076622-001 May 14, 2004 AT RX No No   Start Trial   Start Trial   Start Trial
Daiichi FLOXIN OTIC ofloxacin SOLUTION/DROPS;OTIC 020799-001 Dec 16, 1997 DISCN Yes No   Start Trial   Start Trial   Start Trial
Alvogen OFLOXACIN ofloxacin SOLUTION/DROPS;OTIC 090395-001 Aug 11, 2009 AT RX No No   Start Trial   Start Trial   Start Trial
Larken Labs OFLOXACIN ofloxacin TABLET;ORAL 076093-003 Sep 2, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Fdc Ltd OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 078559-001 Feb 25, 2009 AT RX No No   Start Trial   Start Trial   Start Trial
Larken Labs OFLOXACIN ofloxacin TABLET;ORAL 076093-002 Sep 2, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Apotex Inc OFLOXACIN ofloxacin SOLUTION/DROPS;OTIC 076527-001 Sep 28, 2007 AT 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 OFLOXACIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan OCUFLOX ofloxacin SOLUTION/DROPS;OPHTHALMIC 019921-001 Jul 30, 1993   Start Trial   Start Trial
Ortho Mcneil Pharm FLOXIN ofloxacin INJECTABLE;INJECTION 020087-002 Mar 31, 1992   Start Trial   Start Trial
Daiichi FLOXIN OTIC ofloxacin SOLUTION/DROPS;OTIC 020799-001 Dec 16, 1997   Start Trial   Start Trial
Janssen Pharms FLOXIN ofloxacin TABLET;ORAL 019735-001 Dec 28, 1990   Start Trial   Start Trial
Allergan OCUFLOX ofloxacin SOLUTION/DROPS;OPHTHALMIC 019921-001 Jul 30, 1993   Start Trial   Start Trial
Ortho Mcneil Pharm FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER ofloxacin INJECTABLE;INJECTION 020087-004 Mar 31, 1992   Start Trial   Start Trial
Janssen Pharms FLOXIN ofloxacin TABLET;ORAL 019735-002 Dec 28, 1990   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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