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Last Updated: March 1, 2021

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Tafamidis - Generic Drug Details

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

Tafamidis is the generic ingredient in two branded drugs marketed by Foldrx Pharms and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tafamidis has fifty-three patent family members in twenty-three countries.

One supplier is listed for this compound.

Summary for tafamidis
International Patents:53
US Patents:5
Tradenames:2
Applicants:1
NDAs:2
Suppliers / Packagers: 1
Bulk Api Vendors: 52
Clinical Trials: 20
Patent Applications: 100
DailyMed Link:tafamidis at DailyMed
Recent Clinical Trials for tafamidis

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

SponsorPhase
Boston UniversityEarly Phase 1
Corino Therapeutics, Inc.Early Phase 1
PfizerPhase 1

See all tafamidis clinical trials

US Patents and Regulatory Information for tafamidis

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 Y Y   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 VYNDAMAX tafamidis CAPSULE;ORAL 212161-001 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
>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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1587821 382 Finland   Start Trial
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 C20120001 00050 Estonia   Start Trial PRODUCT NAME: VYNDAQEL - TAFAMIDIS;REG NO/DATE: C(2011)8519 FINAL 16.11.2011
1587821 2012/007 Ireland   Start Trial PRODUCT NAME: VYNDAQEL- TAFAMIDIS MEGLUMINE; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Merck
Dow
Express Scripts
Harvard Business School

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