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Last Updated: March 19, 2024

GATIFLOXACIN - Generic Drug Details


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What are the generic drug sources for gatifloxacin and what is the scope of freedom to operate?

Gatifloxacin is the generic ingredient in three branded drugs marketed by Apotex Inc, Hikma, Lupin Ltd, Rising, Sandoz, Torrent, Allergan, and Abbvie, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for gatifloxacin. Three suppliers are listed for this compound. There is one tentative approval for this compound.

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

Generic filers with tentative approvals for GATIFLOXACIN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial0.3%SOLUTION; OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Abbvie ZYMAXID gatifloxacin SOLUTION/DROPS;OPHTHALMIC 022548-001 May 18, 2010 AT RX Yes Yes ⤷  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
Apotex Inc GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 079084-001 Aug 19, 2011 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 204227-001 Jul 11, 2016 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

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 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ZYMAXID gatifloxacin SOLUTION/DROPS;OPHTHALMIC 022548-001 May 18, 2010 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ZYMAXID gatifloxacin SOLUTION/DROPS;OPHTHALMIC 022548-001 May 18, 2010 ⤷  Try a Trial ⤷  Try a Trial
Allergan ZYMAR gatifloxacin SOLUTION/DROPS;OPHTHALMIC 021493-001 Mar 28, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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