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Last Updated: July 11, 2020

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ZYMAR Drug Profile


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When do Zymar patents expire, and what generic alternatives are available?

Zymar is a drug marketed by Allergan and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty patent family members in sixteen countries.

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

US ANDA Litigation and Generic Entry Outlook for Zymar

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

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Paragraph IV (Patent) Challenges for ZYMAR
Tradename Dosage Ingredient NDA Submissiondate
ZYMAR SOLUTION/DROPS;OPHTHALMIC gatifloxacin 021493 2007-07-19

US Patents and Regulatory Information for ZYMAR

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
>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 ZYMAR

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 ZYMAR gatifloxacin SOLUTION/DROPS;OPHTHALMIC 021493-001 Mar 28, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ZYMAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0230295 300110 Netherlands   Start Trial
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
Express Scripts
AstraZeneca
Moodys
Baxter
Boehringer Ingelheim

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