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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Daiichi Sankyo
Johnson and Johnson
Covington
AstraZeneca
US Department of Justice
Accenture
Express Scripts
Fuji

Generated: July 19, 2018

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Gatifloxacin - Generic Drug Details

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What are the generic sources for gatifloxacin and what is the scope of gatifloxacin freedom to operate?

Gatifloxacin
is the generic ingredient in three branded drugs marketed by Apotex Inc, Hi-tech Pharma Co, Lupin Ltd, Micro Labs, Sandoz Inc, and Allergan, and is included in seven NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Gatifloxacin has twenty patent family members in sixteen countries.

There are sixteen drug master file entries for gatifloxacin. Seven suppliers are listed for this compound. There is one tentative approval for this compound.
Pharmacology for gatifloxacin
Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial
Synonyms for gatifloxacin
(+-)-1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid
1-?CYCLOPROPYL-?6-?FLUORO-?1,?4-?DIHYDRO-?8-?METHOXY-?7-?(3-?METHYL-?1-?PIPERAZINYL)-?4-?OXO-?3-?QUINOLINECARBOXYLIC ACID
1-Cyclopropyl-1,4-dihydro-6-fluoro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid
1-Cyclopropyl-6-6-fluoro-1,4-dihydro-8-methoxy-7-(3methylpiperazin-1-yl)-4-oxo-3-quinolinecarboxylic acid
1-cyclopropyl-6-fluoranyl-8-methoxy-7-(3-methylpiperazin-1-yl)-4-oxidanylidene-quinoline-3-carboxylic acid
1-cyclopropyl-6-fluoro- 8-methoxy-7-(3-methylpiperazin-1-yl)- 4-oxo-quinoline-3-carboxylic acid
1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-
1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid
1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid sesquihydrate
1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methylpiperazin-1-yl)-4-oxo-3-quinolinecarboxylic acid
1-cyclopropyl-6-fluoro-8-methoxy-7-(3-methyl-1-piperazinyl)-1,4-dihydro-4-oxoquinoline-3-carboxylic acid
1-cyclopropyl-6-fluoro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid
1-cyclopropyl-6-fluoro-8-methoxy-7-(3-methyl-piperazin-1-yl)- 4-oxo-1,4-dihydro-quinoline-3-carboxylic acid
1-cyclopropyl-6-fluoro-8-methoxy-7-(3-methylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
1-cyclopropyl-6-fluoro-8-methoxy-7-(3-methylpiperazin-1-yl)-4-oxo-quinoline-3-carboxylic acid
1-cyclopropyl-6-fluoro-8-methoxy-7-(3-methylpiperazin-1-yl)-4-oxoquinoline-3-carboxylic acid
1-Cyclopropyl-6-fluoro-8-methoxy-7-(3-methylpiperazin-1yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
1-cyclopropyl-6-fluoro-8-methoxy-7-(3-methylpiperazino)-4-oxo-1,4-dihydro-3-quinolinecarboxylic acid
1-cyclopropyl-7-(3-methyl-1-piperazinyl)-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid
112811-59-3
160738-57-8
3-Quinolinecarboxylic acid, 1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-
3-Quinolinecarboxylic acid,1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-
811G593
A802657
AB0012064
AB00171654_16
AB00171654_17
AB00171654-13
AB00171654-14
AB1009302
AB2000056
AC-1944
AC1L1K82
AK323595
AKOS004119932
AKOS016340697
ALBB-028535
AM 1155
AM-1155
AM-1155 (*Sesquihydrate*)
AN-14480
AN-30562
AN-31062
API0002807
AX8018671
BB_SC-1123
BBL010485
BC204030
BDBM50117914
BG0576
BMS 206584-01
BMS-206584
BMS-206584-01
Bonoq
BRD-A74980173-001-02-8
BSPBio_002697
C-21242
C07661
CAS-112811-59-3
CC-34682
CCG-39529
CG 5501
CG-5501
CG5501
CHEBI:5280
CHEMBL31
CPD000043336
CS-1841
CTK6J4376
D03CQE
D08011
DB-019145
DB01044
DR002095
DSSTox_CID_25704
DSSTox_GSID_45704
DSSTox_RID_81076
DTXSID5045704
FT-0082686
FT-0626635
FT-0631189
G-2380
G0325
Gaity
Gatiflo
Gatiflo (TN)
Gatiflo,Tequin and Zymar
Gatiflo,Tequin and Zymar, Gatifloxacin
Gatifloxacin (INN)
Gatifloxacin (TN)
Gatifloxacin [USAN:INN]
Gatifloxacin & Gamma Interferon
gatifloxacin anhydrous
Gatifloxacin hydrate
Gatifloxacin, Antibiotic for Culture Media Use Only
Gatifloxacine
gatifloxacino
gatifloxacinum
Gatifloxcin
gatifloxin
Gatilox
Gatiquin
Gatispan
GTFX
HE177167
HE300421
HE315793
HMS1922J15
HMS2090K10
HMS2093G06
HMS2233D20
HMS3259P06
HMS3372J10
HMS3372J12
HY-10581
KB-71352
KBio2_002442
KBio2_005010
KBio2_007578
KBio3_001917
KBioGR_001613
KBioSS_002448
Kinome_3137
KS-00000IXR
KS-1066
LS-184402
MCULE-4557972261
MFCD00895399
MLS000040259
MLS000759493
MLS006011836
MolPort-001-738-626
NC00702
NCGC00068236-02
NCGC00068236-03
NCGC00068236-04
NCGC00068236-05
NCGC00068236-06
NCGC00068236-07
NCGC00068236-08
NCGC00095126-01
NCGC00095126-02
NCGC00178525-01
NSC-758701
NSC758701
PD 135432
PD-135432
PD135432
Pharmakon1600-01504272
PubChem21048
RTR-002479
s1340
SAM001246715
SAM002589955
SBI-0206764.P001
SC-12171
SCHEMBL22591
SMR000043336
SPBio_000353
Spectrum_001909
SPECTRUM1504272
Spectrum2_000487
Spectrum3_000999
Spectrum4_001127
Spectrum5_001468
SR-01000610458
SR-01000610458-2
STK801620
Tequin
Tequin (TN)
Tequin and Zymar
Tequin in dextrose 5% in plastic container
TL8001438
Tox21_110984
Tox21_110984_1
TR-002479
VA11838
XUBOMFCQGDBHNK-UHFFFAOYSA-N
ZX-AN079351
ZX-AP010622
Zymar
Zymar (TN)
Zymaxid
Zymer
Zymer (TN)
Tentative approvals for GATIFLOXACIN
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up0.3%SOLUTION; OPHTHALMIC

US Patents and Regulatory Information for gatifloxacin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Micro Labs GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 206446-001 Jun 8, 2018 AT RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hi-tech Pharma Co GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 203189-001 Sep 3, 2014 AT RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lupin Ltd GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 202653-001 Aug 28, 2013 AT RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Allergan ZYMAXID gatifloxacin SOLUTION/DROPS;OPHTHALMIC 022548-001 May 18, 2010 AT RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 gatifloxacin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan ZYMAR gatifloxacin SOLUTION/DROPS;OPHTHALMIC 021493-001 Mar 28, 2003 ➤ Sign Up ➤ Sign Up
Allergan ZYMAXID gatifloxacin SOLUTION/DROPS;OPHTHALMIC 022548-001 May 18, 2010 ➤ Sign Up ➤ Sign Up
Allergan ZYMAR gatifloxacin SOLUTION/DROPS;OPHTHALMIC 021493-001 Mar 28, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for gatifloxacin

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00110 Netherlands ➤ Sign Up PRODUCT NAME: GATIFLOXACINUM, DESGEWENST IN DE VORM VAN EEN HYDRAAT, ZUURADDITIEZOUT OF ALKALISCH ZOUT, IN HET BIJZONDER GATIFLOXACINUM SESQUIHYDRICUM; REGISTRATION NO/DATE: DE 48870.00.00, 48870.01.00, 48872.00.00, 48872.01.00, 48874.00.00, 48874.01.00, 48876.00.00, 48876.01.00 20011022
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Queensland Health
Cerilliant
Covington
Healthtrust
Deloitte
Fish and Richardson
Daiichi Sankyo
Argus Health

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