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Last Updated: July 16, 2024

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VYNDAQEL Drug Patent Profile


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Which patents cover Vyndaqel, and when can generic versions of Vyndaqel launch?

Vyndaqel is a drug marketed by Foldrx Pharms and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-five patent family members in seventeen countries.

The generic ingredient in VYNDAQEL is tafamidis meglumine. One supplier is listed for this compound. Additional details are available on the tafamidis meglumine profile page.

DrugPatentWatch® Generic Entry Outlook for Vyndaqel

Vyndaqel was eligible for patent challenges on May 3, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 3, 2026. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for VYNDAQEL
Drug Prices for VYNDAQEL

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VYNDAQEL
Generic Entry Date for VYNDAQEL*:
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
NDA:
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 VYNDAQEL

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

SponsorPhase
PfizerPhase 4
PfizerPhase 1
Pfizer

See all VYNDAQEL clinical trials

Paragraph IV (Patent) Challenges for VYNDAQEL
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 VYNDAQEL

VYNDAQEL is protected by two US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VYNDAQEL is ⤷  Sign Up.

This potential generic entry date is based on TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY AND CARDIOVASCULAR-RELATED HOSPITALIZATION.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VYNDAQEL

Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM)

FDA Regulatory Exclusivity protecting VYNDAQEL

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM) IN ADULTS TO REDUCE CARDIOVASCULAR MORTALITY AND CARDIOVASCULAR-RELATED HOSPITALIZATION
Exclusivity Expiration: ⤷  Sign Up

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

International Patents for VYNDAQEL

See the table below for patents covering VYNDAQEL around the world.

Country Patent Number Title Estimated Expiration
Austria 524741 ⤷  Sign Up
European Patent Office 1587821 ⤷  Sign Up
European Patent Office 2325651 Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding ⤷  Sign Up
Slovenia 1587821 ⤷  Sign Up
South Korea 20050090410 ⤷  Sign Up
Brazil PI0317463 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VYNDAQEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1587821 91935 Luxembourg ⤷  Sign Up 91935, EXPIRES: 20261116
1587821 SPC/GB12/009 United Kingdom ⤷  Sign Up PRODUCT NAME: TAFAMIDIS, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE MEGLUMINE SALT; REGISTERED: UK EU/1/11/717/001 20111118
1587821 126 5003-2012 Slovakia ⤷  Sign Up PRODUCT NAME: TAFAMIDIS MEGLUMIN; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
1587821 1290005-6 Sweden ⤷  Sign Up PERIOD OF VALIDITY AFTER CORRECTION (FROM - UNTIL): 20231220 - 20261117
1587821 12C0008 France ⤷  Sign Up PRODUCT NAME: TAFAMIDIS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/11/717/001 20111118
1587821 C300516 Netherlands ⤷  Sign Up 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
>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.