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Last Updated: September 16, 2021

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Gatifloxacin - Generic Drug Details

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What are the generic sources for gatifloxacin and what is the scope of patent protection?

Gatifloxacin is the generic ingredient in three branded drugs marketed by Akorn, Apotex Inc, Lupin Ltd, Mylan, Sandoz Inc, and Allergan, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for gatifloxacin. Five 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
Laboratorios Sophia S.A de C.V.Phase 3
Carolina Eyecare Physicians, LLCPhase 4

See all gatifloxacin clinical trials

Generic filers with tentative approvals for GATIFLOXACIN
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever 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
Sandoz Inc GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 204227-001 Jul 11, 2016 AT RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mylan GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 206446-001 Jun 8, 2018 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Apotex Inc GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 079084-001 Aug 19, 2011 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan ZYMAXID gatifloxacin SOLUTION/DROPS;OPHTHALMIC 022548-001 May 18, 2010 AT RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Lupin Ltd GATIFLOXACIN gatifloxacin SOLUTION/DROPS;OPHTHALMIC 202653-001 Aug 28, 2013 AT RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan ZYMAXID gatifloxacin SOLUTION/DROPS;OPHTHALMIC 022548-001 May 18, 2010 ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan ZYMAR gatifloxacin SOLUTION/DROPS;OPHTHALMIC 021493-001 Mar 28, 2003 ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan ZYMAXID gatifloxacin SOLUTION/DROPS;OPHTHALMIC 022548-001 May 18, 2010 ⤷  Free Forever Trial ⤷  Free Forever Trial
Allergan ZYMAR gatifloxacin SOLUTION/DROPS;OPHTHALMIC 021493-001 Mar 28, 2003 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
Colorcon
Baxter
Mallinckrodt
Dow

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