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Last Updated: September 25, 2023

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 sixty-three patent family members in twenty-eight countries.

One supplier is listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for tafamidis
Generic Entry Date for tafamidis*:
Constraining patent/regulatory exclusivity:

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for tafamidis

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

University of Texas Southwestern Medical CenterPhase 4
Yale UniversityPhase 1
Columbia UniversityPhase 4

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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Foldrx Pharms VYNDAMAX tafamidis CAPSULE;ORAL 212161-001 May 3, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Foldrx Pharms VYNDAQEL tafamidis meglumine CAPSULE;ORAL 211996-001 May 3, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Foldrx Pharms VYNDAMAX tafamidis CAPSULE;ORAL 212161-001 May 3, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for tafamidis

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pfizer Europe MA EEIG Vyndaqel tafamidis EMEA/H/C/002294
Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage-1 symptomatic polyneuropathy to delay peripheral neurologic impairment.
Authorised no no yes 2011-11-16
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for tafamidis

Country Patent Number Title Estimated Expiration
Japan 2020055832 6−カルボキシ−2−(3,5−ジクロロフェニル)−ベンゾオキサゾールの結晶性固体形態 (CRYSTALLINE SOLID FORMS OF 6-CARBOXY-2-(3,5-DICHLOROPHENYL)-BENZOXAZOLE) ⤷  Try a Trial
Denmark 1587821 ⤷  Try a Trial
Denmark 1988397 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tafamidis

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1587821 382 Finland ⤷  Try a Trial
1587821 CA 2012 00006 Denmark ⤷  Try a Trial
1587821 6/2012 Austria ⤷  Try a Trial PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
1587821 126 5003-2012 Slovakia ⤷  Try a Trial PRODUCT NAME: TAFAMIDIS MEGLUMIN; 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:

Express Scripts
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.