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Last Updated: January 26, 2020

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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 freedom to operate?

Tafluprost is the generic ingredient in two branded drugs marketed by Micro Labs and Oak Pharms Inc, 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 seventy-one 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
Taejoon Pharmaceutical Co., Ltd.Phase 4
wangdaboN/A
Santen OyPhase 4

See all tafluprost clinical trials

Recent Litigation for tafluprost

Identify potential future generic entrants

District Court Litigation
Case NameDate
SANTEN PHARMACEUTICAL CO. LTD. v. MICRO LABS LIMITED2018-08-01
Santen Pharmaceutical Co., Ltd. v. Micro Labs Limited2016-05-13
Santen Pharmaceutical Co., Ltd. v. Sandoz Inc.2016-05-13

See all tafluprost litigation

PTAB Litigation
PetitionerDate
Micro Labs Limited2017-05-12

See all tafluprost litigation

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.

Pharmacology for tafluprost
Synonyms for tafluprost
(Z)-isopropyl 7-((1R,2R,3R,5S)-2-((E)-3,3-difluoro-4-phenoxybut-1-en-1-yl)-3,5-dihydroxy cyclopentyl)hept-5-enoate
(Z)-isopropyl 7-((1R,2R,3R,5S)-2-((E)-3,3-difluoro-4-phenoxybut-1-en-1-yl)-3,5-dihydroxycyclopentyl)hept-5-enoate
1-methylethyl (5Z)-7-((1R,2R, 3R,5S)-2-((1E)-3,3-difluoro-4-phenoxy -1-butenyl-3,5-dihydroxycyclopentyl)-5-heptenoate
1-methylethyl (5Z)-7-{(1R,2R,3R,5S)-2-((1E)-3,3-difluoro-4-phenoxybut-1-enyl)-3,5- dihydroxycyclopentyl}hept-5-enoate
1O6WQ6T7G3
209860-87-7
5-Heptenoic acid, 7-((1R,2R,3R,5S)-2-((1E)-3,3-difluoro-4-phenoxy-1-buten-1-yl)-3,5- dihydroxycyclopentyl)-, 1-methylethyl ester, (5Z)-
5-Heptenoic acid, 7-[(1R,2R,3R,5S)-2-[(1E)-3,3-difluoro-4-phenoxy-1-butenyl]-3,5-dihydroxycyclopentyl]-, 1-methylethyl ester, (5Z)-
860T877
AFP-168
AFP-168;MK2452
AKOS025294885
AN-5815
C25H34F2O5
CHEBI:66899
CHEMBL1963683
CS-2817
D06274
DB08819
DE-085
DE-118
EX-A564
GTPL7451
HMS3649F04
HY-B0600
Isopropyl (5Z)-7-{(1R,2R,3R,5S)-2-((1E)-3,3-difluoro-4-phenoxybut-1-enyl)-3,5-dihydroxycyclopentyl}hept-5-enoate
isopropyl (5Z)-7-{(1R,2R,3R,5S)-2-[(1E)-3,3-difluoro-4-phenoxybut-1-en-1-yl]-3,5-dihydroxycyclopentyl}hept-5-enoate
isopropyl (Z)-7-((1R,2R,3R,5S)-2-((E)-3,3-difluoro-4-phenoxybut-1-en-1-yl)-3,5-dihydroxycyclopentyl)hept-5-enoate
isopropyl (Z)-7-[(1R,2R,3R,5S)-2-[(E)-3,3-difluoro-4-phenoxy-but-1-enyl]-3,5-dihydroxy-cyclopentyl]hept-5-enoate
J-502635
MK-2452
MK2452
MolPort-020-006-049
propan-2-yl (5Z)-7-[(1R,2R,3R,5S)-2-[(1E)-3,3-difluoro-4-phenoxybut-1-en-1-yl]-3,5-dihydroxycyclopentyl]hept-5-enoate
propan-2-yl (Z)-7-[(1R,2R,3R,5S)-2-[(E)-3,3-difluoro-4-(phenoxy)but-1-enyl]-3,5-dihydroxycyclopentyl]hept-5-enoate
RP17751
Saflutan
SCHEMBL1286148
SR-01000946707
SR-01000946707-1
Taflotan
Tafluprost (JAN/USAN/INN)
Tafluprost [USAN:INN:BAN]
Tafluprost isopropyl ester
Tapros
Tapros|||Taflotan
UNII-1O6WQ6T7G3
WSNODXPBBALQOF-VEJSHDCNSA-N
X2642
ZINC13912394
Zioptan
Zioptan (TN)
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
Oak Pharms Inc ZIOPTAN tafluprost SOLUTION/DROPS;OPHTHALMIC 202514-001 Feb 10, 2012 AT RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Micro Labs TAFLUPROST tafluprost SOLUTION/DROPS;OPHTHALMIC 209051-001 Aug 19, 2019 AT RX No No   Start Trial   Start Trial   Start Trial
Oak Pharms Inc ZIOPTAN tafluprost SOLUTION/DROPS;OPHTHALMIC 202514-001 Feb 10, 2012 AT RX Yes Yes   Start Trial   Start Trial Y 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 C00850926/01 Switzerland   Start Trial PRODUCT NAME: TAFLUPROST; REGISTRATION NO/DATE: SWISSMEDIC 60548 27.01.2010
0850926 91943 Luxembourg   Start Trial 91943, EXPIRES: 20221222
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
0850926 CA 2008 00041 Denmark   Start Trial
0850926 SPC013/2011 Ireland   Start Trial SPC013/2011: 20110808, EXPIRES: 20221221
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
Moodys
AstraZeneca
Dow
Merck

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