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Last Updated: March 9, 2021

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Tafamidis meglumine - Generic Drug Details

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What are the generic 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: 13
Clinical Trials: 7
Patent Applications: 5
What excipients (inactive ingredients) are in tafamidis meglumine?tafamidis meglumine excipients list
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 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 C 2012 004 Romania   Start Trial PRODUCT NAME: TAFAMIDISMEGLUMINA; NATIONAL AUTHORISATION NUMBER: EU/1/11/717/001; DATE OF NATIONAL AUTHORISATION: 20111116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/717/001; DATE OF FIRST AUTHORISATION IN EEA: 20111116
1587821 CR 2012 00006 Denmark   Start Trial PRODUCT NAME: TAFAMIDIS (SOM MEGLUMIN); REG. NO/DATE: EU/1/11/717/001 20111116
1587821 SPC/GB12/009 United Kingdom   Start Trial PRODUCT NAME: TAFAMIDIS, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE MEGLUMINE SALT; REGISTERED: UK EU/1/11/717/001 20111118
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Boehringer Ingelheim
Mallinckrodt
Express Scripts
Moodys
Merck

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