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Last Updated: September 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 three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are three drug master file entries for tafluprost. One supplier is listed for this compound. 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
⤷  Try it Free⤷  Try it Free0.0015%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.

Pharmacology for tafluprost
Anatomical Therapeutic Chemical (ATC) Classes for tafluprost
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
Akorn ZIOPTAN tafluprost SOLUTION/DROPS;OPHTHALMIC 202514-001 Feb 10, 2012 AT RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Akorn ZIOPTAN tafluprost SOLUTION/DROPS;OPHTHALMIC 202514-001 Feb 10, 2012 AT RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Micro Labs TAFLUPROST tafluprost SOLUTION/DROPS;OPHTHALMIC 209051-001 Aug 19, 2019 AT RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Akorn ZIOPTAN tafluprost SOLUTION/DROPS;OPHTHALMIC 202514-001 Feb 10, 2012 AT RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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 SPC013/2011 Ireland ⤷  Try it Free SPC013/2011: 20110808, EXPIRES: 20221221
0850926 300407 Netherlands ⤷  Try it Free 300407, 20171222, EXPIRES: 20221221
0850926 11C0020 France ⤷  Try it Free PRODUCT NAME: TAFLUPROST; REGISTRATION NO/DATE IN FRANCE: CIS:6 000 728 O DU 20110328; REGISTRATION NO/DATE AT EEC: 43230 DU 20080430
0850926 C00850926/01 Switzerland ⤷  Try it Free PRODUCT NAME: TAFLUPROST; REGISTRATION NO/DATE: SWISSMEDIC 60548 27.01.2010
0850926 339 Finland ⤷  Try it Free
0850926 CA 2008 00041 Denmark ⤷  Try it Free
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
AstraZeneca
McKinsey
Medtronic
Boehringer Ingelheim
Dow

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