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Last Updated: August 5, 2020

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Tafamidis meglumine - Generic Drug Details

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What are the generic drug sources for tafamidis meglumine and what is the scope of patent protection?

Tafamidis meglumine is the generic ingredient in one branded drug marketed by Foldrx Pharms and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tafamidis meglumine has thirty-five patent family members in seventeen countries.

One supplier is listed for this compound.

Summary for tafamidis meglumine
International Patents:35
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 8
Clinical Trials: 6
Patent Applications: 5
DailyMed Link:tafamidis meglumine at DailyMed
Recent Clinical Trials for tafamidis meglumine

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

SponsorPhase
PfizerPhase 1
PfizerPhase 3

See all tafamidis meglumine clinical trials

US Patents and Regulatory Information for tafamidis meglumine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Foldrx Pharms VYNDAQEL tafamidis meglumine CAPSULE;ORAL 211996-001 May 3, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Foldrx Pharms VYNDAQEL tafamidis meglumine CAPSULE;ORAL 211996-001 May 3, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Foldrx Pharms VYNDAQEL tafamidis meglumine CAPSULE;ORAL 211996-001 May 3, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Foldrx Pharms VYNDAQEL tafamidis meglumine CAPSULE;ORAL 211996-001 May 3, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Foldrx Pharms VYNDAQEL tafamidis meglumine CAPSULE;ORAL 211996-001 May 3, 2019 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Foldrx Pharms VYNDAQEL tafamidis meglumine CAPSULE;ORAL 211996-001 May 3, 2019 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 tafamidis meglumine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1587821 91935 Luxembourg   Start Trial 91935, EXPIRES: 20261116
1587821 12C0008 France   Start Trial PRODUCT NAME: TAFAMIDIS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
1587821 C300516 Netherlands   Start Trial PRODUCT NAME: TAFAMIDIS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER TAFAMIDIS MEGLUMINE ZOUT; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
1587821 CR 2012 00006 Denmark   Start Trial PRODUCT NAME: TAFAMIDIS (SOM MEGLUMIN); REG. NO/DATE: EU/1/11/717/001 20111116
1587821 1290005-6 Sweden   Start Trial PRODUCT NAME: TAFAMIDIS; REG. NO/DATE: EU/1/11/717/001 20111116
1587821 2012/007 Ireland   Start Trial PRODUCT NAME: VYNDAQEL- TAFAMIDIS MEGLUMINE; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
1587821 6/2012 Austria   Start Trial PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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