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Serving 500+ biopharmaceutical companies globally:

Merck
Daiichi Sankyo
Covington
Chinese Patent Office
Cerilliant
Farmers Insurance
Johnson and Johnson
Deloitte
Express Scripts
Julphar

Generated: June 27, 2017

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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 Sandoz Inc, Allergan, Lupin Ltd, Apotex Inc, and Hi-tech Pharma Co, and is included in six NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Gatifloxacin has sixteen patent family members in fifteen 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.

Summary for Generic Name: gatifloxacin

Tradenames:3
Patents:2
Applicants:5
NDAs:6
Drug Master File Entries: see list16
Suppliers / Packagers: see list7
Bulk Api Vendors: see list80
Clinical Trials: see list27
Patent Applications: see list5,609
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:gatifloxacin at DailyMed

Pharmacology for Ingredient: gatifloxacin

Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial

Tentative approvals for GATIFLOXACIN

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe0.3%SOLUTION; OPHTHALMIC
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan
ZYMAXID
gatifloxacin
SOLUTION/DROPS;OPHTHALMIC022548-001May 18, 2010ATRXYesYes► Subscribe► Subscribe
Hi-tech Pharma Co
GATIFLOXACIN
gatifloxacin
SOLUTION/DROPS;OPHTHALMIC203189-001Sep 3, 2014ATRXNoNo► Subscribe► Subscribe
Sandoz Inc
GATIFLOXACIN
gatifloxacin
SOLUTION/DROPS;OPHTHALMIC204227-001Jul 11, 2016ATRXNoNo► Subscribe► Subscribe
Apotex Inc
GATIFLOXACIN
gatifloxacin
SOLUTION/DROPS;OPHTHALMIC079084-001Aug 19, 2011DISCNNoNo► Subscribe► Subscribe
Allergan
ZYMAR
gatifloxacin
SOLUTION/DROPS;OPHTHALMIC021493-001Mar 28, 2003RXYesYes6,333,045*PED► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: gatifloxacin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan
ZYMAXID
gatifloxacin
SOLUTION/DROPS;OPHTHALMIC022548-001May 18, 20105,880,283*PED► Subscribe
Allergan
ZYMAR
gatifloxacin
SOLUTION/DROPS;OPHTHALMIC021493-001Mar 28, 20035,880,283*PED► Subscribe
Allergan
ZYMAR
gatifloxacin
SOLUTION/DROPS;OPHTHALMIC021493-001Mar 28, 20034,980,470*PED► Subscribe
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International Patent Family for Ingredient: gatifloxacin

Country Document Number Estimated Expiration
New Zealand504017► Subscribe
China1133432► Subscribe
Spain2264266► Subscribe
World Intellectual Property Organization (WIPO)0010570► Subscribe
Portugal1025846► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: GATIFLOXACIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00110Netherlands► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Queensland Health
UBS
US Army
Healthtrust
Dow
McKesson
Teva
Moodys
Chubb
Fuji

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.

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