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Last Updated: January 25, 2021

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ZIOPTAN Drug Profile

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Which patents cover Zioptan, and what generic alternatives are available?

Zioptan is a drug marketed by Akorn and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-three patent family members in thirty-one countries.

The generic ingredient in ZIOPTAN is tafluprost. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tafluprost profile page.

US ANDA Litigation and Generic Entry Outlook for Zioptan

A generic version of ZIOPTAN was approved as tafluprost by MICRO LABS on August 19th, 2019.

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Paragraph IV (Patent) Challenges for ZIOPTAN
Tradename Dosage Ingredient NDA Submissiondate
ZIOPTAN SOLUTION/DROPS;OPHTHALMIC tafluprost 202514 2016-02-10

US Patents and Regulatory Information for ZIOPTAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Akorn ZIOPTAN tafluprost SOLUTION/DROPS;OPHTHALMIC 202514-001 Feb 10, 2012 AT RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Akorn ZIOPTAN tafluprost SOLUTION/DROPS;OPHTHALMIC 202514-001 Feb 10, 2012 AT RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ZIOPTAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0850926 11C0020 France   Start Trial PRODUCT NAME: TAFLUPROST; REGISTRATION NO/DATE IN FRANCE: CIS:6 000 728 O DU 20110328; REGISTRATION NO/DATE AT EEC: 43230 DU 20080430
0850926 CA 2008 00041 Denmark   Start Trial
0850926 C00850926/01 Switzerland   Start Trial PRODUCT NAME: TAFLUPROST; REGISTRATION NO/DATE: SWISSMEDIC 60548 27.01.2010
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Baxter
McKesson
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Boehringer Ingelheim
McKinsey

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