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Last Updated: August 8, 2020

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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, Hi-tech Pharma Co, Lupin Ltd, Mylan, Sandoz Inc, and Allergan, and is included in seven 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. Six 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
Laboratorios Sophia S.A de C.V.Phase 3
Imprimis Pharmaceuticals, Inc.Phase 4
Science in VisionPhase 4

See all GATIFLOXACIN clinical trials

Generic filers with tentative approvals for GATIFLOXACIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start 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 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
Allergan ZYMAR gatifloxacin SOLUTION/DROPS;OPHTHALMIC 021493-001 Mar 28, 2003 RX Yes Yes   Start Trial   Start Trial   Start Trial
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
>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   Start Trial   Start Trial
Allergan ZYMAR gatifloxacin SOLUTION/DROPS;OPHTHALMIC 021493-001 Mar 28, 2003   Start Trial   Start Trial
Allergan ZYMAXID gatifloxacin SOLUTION/DROPS;OPHTHALMIC 022548-001 May 18, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for GATIFLOXACIN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0230295 C300110 Netherlands   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Harvard Business School
McKesson
Moodys
Medtronic
Baxter

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