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Last Updated: August 14, 2020

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US ANDA Litigation and Generic Entry Outlook for Gatifloxacin

A generic version of GATIFLOXACIN was approved as gatifloxacin by LUPIN LTD on August 28th, 2013.

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Drug patent expirations by year for GATIFLOXACIN
Drug Prices for GATIFLOXACIN

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Drug Sales Revenue Trends for GATIFLOXACIN

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Recent Clinical Trials for GATIFLOXACIN

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

Laboratorios Sophia S.A de C.V.Phase 3
Science in VisionPhase 4
Carolina Eyecare Physicians, LLCPhase 4

See all GATIFLOXACIN clinical trials

Pharmacology for GATIFLOXACIN
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
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
Hi-tech Pharma Co GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 203189-001 Sep 3, 2014 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
>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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Serving leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim

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