Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Farmers Insurance
Citi
Teva
Covington
US Department of Justice
Fuji
Healthtrust
Deloitte
Queensland Health
Fish and Richardson

Generated: December 12, 2017

DrugPatentWatch Database Preview

Gatifloxacin - Generic Drug Details

« Back to Dashboard

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, Sandoz Inc, and Allergan, and is included in six 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 eighteen patent family members in fifteen countries and one supplementary protection certificate in one country.

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

Tentative approvals for GATIFLOXACIN

Applicant Application No. Strength Dosage Form
u► Subscribe0.3%SOLUTION; OPHTHALMIC
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
AllerganZYMAXIDgatifloxacinSOLUTION/DROPS;OPHTHALMIC022548-001May 18, 2010ATRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Hi-tech Pharma CoGATIFLOXACINgatifloxacinSOLUTION/DROPS;OPHTHALMIC203189-001Sep 3, 2014ATRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Lupin LtdGATIFLOXACINgatifloxacinSOLUTION/DROPS;OPHTHALMIC202653-001Aug 28, 2013ATRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Apotex IncGATIFLOXACINgatifloxacinSOLUTION/DROPS;OPHTHALMIC079084-001Aug 19, 2011DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sandoz IncGATIFLOXACINgatifloxacinSOLUTION/DROPS;OPHTHALMIC204227-001Jul 11, 2016ATRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
AllerganZYMARgatifloxacinSOLUTION/DROPS;OPHTHALMIC021493-001Mar 28, 2003RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: gatifloxacin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
AllerganZYMARgatifloxacinSOLUTION/DROPS;OPHTHALMIC021493-001Mar 28, 2003► Subscribe► Subscribe
AllerganZYMAXIDgatifloxacinSOLUTION/DROPS;OPHTHALMIC022548-001May 18, 2010► Subscribe► Subscribe
AllerganZYMARgatifloxacinSOLUTION/DROPS;OPHTHALMIC021493-001Mar 28, 2003► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: gatifloxacin

Country Document Number Estimated Expiration
Denmark1025846► Subscribe
Hong Kong1029934► Subscribe
Spain2264266► Subscribe
World Intellectual Property Organization (WIPO)0010570► Subscribe
Canada2307632► Subscribe
Portugal1025846► Subscribe
Japan5138128► Subscribe
Taiwan537895► Subscribe
BrazilPI9906735► Subscribe
Australia761040► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Cerilliant
Baxter
Accenture
Chubb
Covington
Julphar
Queensland Health
Farmers Insurance
Fish and Richardson

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot