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Last Updated: January 21, 2021

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TAFLUPROST - Generic Drug Details

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

Tafluprost is the generic ingredient in two branded drugs marketed by Micro Labs and Akorn, and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are three drug master file entries for tafluprost. There is one tentative approval for this compound.

Recent Clinical Trials for TAFLUPROST

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Tun Hussein Onn National Eye HospitalPhase 4
Taejoon Pharmaceutical Co., Ltd.Phase 4
wangdaboN/A

See all TAFLUPROST clinical trials

Generic filers with tentative approvals for TAFLUPROST
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.0015%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.

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

US Patents and Regulatory Information for TAFLUPROST

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Micro Labs TAFLUPROST tafluprost SOLUTION/DROPS;OPHTHALMIC 209051-001 Aug 19, 2019 AT RX No No   Start Trial   Start Trial   Start Trial
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 TAFLUPROST

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0850926 CA 2008 00041 Denmark   Start Trial
0850926 91943 Luxembourg   Start Trial 91943, EXPIRES: 20221222
0850926 SPC013/2011 Ireland   Start Trial SPC013/2011: 20110808, EXPIRES: 20221221
0850926 300407 Netherlands   Start Trial 300407, 20171222, EXPIRES: 20221221
0850926 339 Finland   Start Trial
0850926 SPC/GB09/005 United Kingdom   Start Trial PRODUCT NAME: TAFLUPROST OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: DK 43230 20080430; UK PL 16058/0011-0001 20081017
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Express Scripts
Mallinckrodt
Moodys
McKesson
Colorcon

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