Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Colorcon
Baxter
Harvard Business School
McKesson
Boehringer Ingelheim
McKinsey

Last Updated: November 17, 2019

DrugPatentWatch Database Preview

Gatifloxacin - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

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

Gatifloxacin is the generic ingredient in three branded drugs marketed by Apotex Inc, Hi-tech Pharma Co, Lupin Ltd, Mylan, 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. Six suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for gatifloxacin

See drug prices for gatifloxacin

Drug Sales Revenue Trends for gatifloxacin

See drug sales revenues for gatifloxacin

Recent Clinical Trials for gatifloxacin

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

SponsorPhase
Laboratorios Sophia S.A de C.V.Phase 3
Carolina Eyecare Physicians, LLCPhase 4
Imprimis Pharmaceuticals, Inc.Phase 4

See all gatifloxacin clinical trials

Recent Litigation for gatifloxacin

Identify potential future generic entrants

District Court Litigation
Case NameDate
Hartig Drug Co Inc v. Senju Pharmaceutical Co Ltd2015-09-21
Senju Pharmaceutical Co. Ltd. v. Aurobindo Pharma Ltd.2014-05-02
Senju Pharmaceutical Co. v. Lupin Limited2013-09-10

See all gatifloxacin litigation

Generic filers with tentative approvals for GATIFLOXACIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.3%SOLUTION; OPHTHALMIC

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 gatifloxacin
Synonyms for gatifloxacin
(+-)-1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid
(3-methylpiperazin-1-yl)-4-oxo-1,4-
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-(3-methylpiperazin-1-yl)-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-
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
BBL010485
BC204030
BCP13408
BDBM50117914
BG0576
BMS 206584-01
BMS-206584
BMS-206584-01
Bonoq
BRD-A74980173-001-02-8
BRD-A74980173-001-06-9
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
D08011
DB-019145
DB01044
DSSTox_CID_25704
DSSTox_GSID_45704
DSSTox_RID_81076
DTXSID5045704
FT-0082686
FT-0626635
FT-0631189
G-2380
G0325
Gaity
Gatiflo
Gatiflo,Tequin and Zymar
Gatifloxacin (INN)
Gatifloxacin (TN)
Gatifloxacin [USAN:INN]
Gatifloxacin & Gamma Interferon
gatifloxacin anhydrous
Gatifloxacin Sesquihydrate,(S)
Gatifloxacin, 98%
Gatifloxacin, Antibiotic for Culture Media Use Only
Gatifloxacin,(S)
Gatifloxacine
gatifloxacino
gatifloxacinum
Gatifloxcin
gatifloxin
Gatilox
Gatiquin
Gatispan
GTFX
HMS1922J15
HMS2090K10
HMS2093G06
HMS2233D20
HMS3259P06
HMS3372J10
HMS3372J12
HMS3715N03
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
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
RKL10068
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
SR-01000610458-3
STK801620
Tequin
Tequin and Zymar
Tequin in dextrose 5% in plastic container
TL8001438
Tox21_110984
Tox21_110984_1
TR-002479
Tymer
VA11838
XUBOMFCQGDBHNK-UHFFFAOYSA-N
ZX-AN079351
ZX-AP010622
Zymar
Zymaxid
Zymer (TN)
Paragraph IV (Patent) Challenges for GATIFLOXACIN
Tradename Dosage Ingredient NDA Submissiondate
ZYMAXID SOLUTION/DROPS;OPHTHALMIC gatifloxacin 022548 2010-12-07
ZYMAR SOLUTION/DROPS;OPHTHALMIC gatifloxacin 021493 2007-07-19

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
Sandoz Inc GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 204227-001 Jul 11, 2016 AT RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 079084-001 Aug 19, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 206446-001 Jun 8, 2018 AT RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 202653-001 Aug 28, 2013 AT RX No No   Start Trial   Start Trial   Start Trial
Hi-tech Pharma Co GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 203189-001 Sep 3, 2014 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 gatifloxacin

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

Supplementary Protection Certificates for gatifloxacin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0230295 C300110 Netherlands   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
AstraZeneca
Express Scripts
Dow
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.