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Last Updated: March 3, 2024

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
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for tafamidis meglumine
Generic Entry Date for tafamidis meglumine*:
Constraining patent/regulatory exclusivity:
TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY AND CARDIOVASCULAR-RELATED HOSPITALIZATION
Dosage:
CAPSULE;ORAL

*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 meglumine

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

SponsorPhase
PfizerPhase 4
PfizerPhase 1
PfizerPhase 3

See all tafamidis meglumine clinical trials

Paragraph IV (Patent) Challenges for TAFAMIDIS MEGLUMINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VYNDAQEL Capsules tafamidis meglumine 20 mg 211996 1 2023-05-03

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 ⤷  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 VYNDAQEL tafamidis meglumine CAPSULE;ORAL 211996-001 May 3, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  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

Expired US Patents for tafamidis meglumine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Foldrx Pharms VYNDAQEL tafamidis meglumine CAPSULE;ORAL 211996-001 May 3, 2019 ⤷  Try a Trial ⤷  Try a Trial
Foldrx Pharms VYNDAQEL tafamidis meglumine CAPSULE;ORAL 211996-001 May 3, 2019 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for tafamidis meglumine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1587821 12C0008 France ⤷  Try a Trial PRODUCT NAME: TAFAMIDIS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/11/717/001 20111118
1587821 6/2012 Austria ⤷  Try a Trial PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
1587821 91935 Luxembourg ⤷  Try a Trial 91935, EXPIRES: 20261116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.