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Last Updated: March 19, 2024

GATIFLOXACIN Drug Patent Profile


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When do Gatifloxacin patents expire, and when can generic versions of Gatifloxacin launch?

Gatifloxacin is a drug marketed by Apotex Inc, Hikma, Lupin Ltd, Rising, Sandoz, and Torrent. and is included in six NDAs.

The generic ingredient in GATIFLOXACIN is gatifloxacin. There are sixteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the gatifloxacin profile page.

DrugPatentWatch® 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

SponsorPhase
Shaheed Benazir Bhutto University Sheringal Dir UpperPhase 1
Khyber Medical University PeshawarPhase 1
Laboratorios Sophia S.A de C.V.Phase 3

See all GATIFLOXACIN clinical trials

Pharmacology for GATIFLOXACIN
Paragraph IV (Patent) Challenges for GATIFLOXACIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZYMAXID Ophthalmic Solution gatifloxacin 0.5 % 022548 1 2010-12-07
ZYMAR Ophthalmic Solution gatifloxacin 0.3 % 021493 1 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 206446-001 Jun 8, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 203189-001 Sep 3, 2014 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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