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Generated: May 24, 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?

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

Drug Master File Entries: see list16
Suppliers / Packagers: see list7
Bulk Api Vendors: see list80
Clinical Trials: see list11
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

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
SOLUTION/DROPS;OPHTHALMIC021493-001Mar 28, 2003RXYesYes6,333,045*PED► SubscribeY► Subscribe
SOLUTION/DROPS;OPHTHALMIC022548-001May 18, 2010ATRXYesYes► Subscribe► Subscribe
Apotex Inc
SOLUTION/DROPS;OPHTHALMIC079084-001Aug 19, 2011DISCNNoNo► Subscribe► Subscribe
Lupin Ltd
SOLUTION/DROPS;OPHTHALMIC202653-001Aug 28, 2013ATRXNoNo► Subscribe► Subscribe
Hi-tech Pharma Co
SOLUTION/DROPS;OPHTHALMIC203189-001Sep 3, 2014ATRXNoNo► Subscribe► Subscribe
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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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