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Serving leading biopharmaceutical companies globally:

Deloitte
Moodys
Cantor Fitzgerald
US Army
Federal Trade Commission
Chubb
Citi
Mallinckrodt
McKinsey
Healthtrust

Generated: February 19, 2018

DrugPatentWatch Database Preview

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, 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 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
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
Lupin Ltd GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 202653-001 Aug 28, 2013 AT RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 079084-001 Aug 19, 2011 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sandoz Inc GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 204227-001 Jul 11, 2016 AT RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Allergan ZYMAR gatifloxacin SOLUTION/DROPS;OPHTHALMIC 021493-001 Mar 28, 2003 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Allergan ZYMAXID gatifloxacin SOLUTION/DROPS;OPHTHALMIC 022548-001 May 18, 2010 AT RX Yes Yes ➤ 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
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 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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for gatifloxacin

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:

US Army
Accenture
Fuji
Citi
Baxter
AstraZeneca
Cerilliant
McKinsey
QuintilesIMS

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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