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Last Updated: May 27, 2022

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 four patents protecting this drug.

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 will be eligible for patent challenges on May 3, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

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Summary for VYNDAQEL
International Patents:35
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 4
Drug Prices: Drug price information for VYNDAQEL
What excipients (inactive ingredients) are in VYNDAQEL?VYNDAQEL excipients list
DailyMed Link:VYNDAQEL at DailyMed
Drug patent expirations by year for VYNDAQEL
Drug Prices for VYNDAQEL

See drug prices for VYNDAQEL

DrugPatentWatch® Estimated Generic Entry Opportunity 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

US Patents and Regulatory Information for VYNDAQEL

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VYNDAQEL is See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

Pharmaceutically acceptable salt of 6-carboxy-2-(3,5 dichlorophenyl)-benzoxazole, and a pharmaceutical composition comprising the salt thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for treating transthyretin amyloid diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

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: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Foldrx Pharms VYNDAQEL tafamidis meglumine CAPSULE;ORAL 211996-001 May 3, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Foldrx Pharms VYNDAQEL tafamidis meglumine CAPSULE;ORAL 211996-001 May 3, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Foldrx Pharms VYNDAQEL tafamidis meglumine CAPSULE;ORAL 211996-001 May 3, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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

When does loss-of-exclusivity occur for VYNDAQEL?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 03303196
Estimated Expiration: See Plans and Pricing

Patent: 10201263
Estimated Expiration: See Plans and Pricing

Austria

Patent: 5840
Estimated Expiration: See Plans and Pricing

Patent: 4741
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 17463
Estimated Expiration: See Plans and Pricing

Patent: 0317463
Estimated Expiration: See Plans and Pricing

Canada

Patent: 10455
Estimated Expiration: See Plans and Pricing

Patent: 00237
Estimated Expiration: See Plans and Pricing

China

Patent: 47965
Estimated Expiration: See Plans and Pricing

Patent: 0448852
Estimated Expiration: See Plans and Pricing

Patent: 1413143
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 08467
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 87821
Estimated Expiration: See Plans and Pricing

Patent: 88397
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 87821
Estimated Expiration: See Plans and Pricing

Patent: 88397
Estimated Expiration: See Plans and Pricing

Patent: 25651
Estimated Expiration: See Plans and Pricing

Germany

Patent: 323155
Estimated Expiration: See Plans and Pricing

Patent: 2012000007
Estimated Expiration: See Plans and Pricing

Japan

Patent: 65076
Estimated Expiration: See Plans and Pricing

Patent: 56151
Estimated Expiration: See Plans and Pricing

Patent: 06511612
Estimated Expiration: See Plans and Pricing

Patent: 10270134
Estimated Expiration: See Plans and Pricing

Patent: 13256521
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 935
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 87821
Estimated Expiration: See Plans and Pricing

Patent: 88397
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 87821
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0505034
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1089904
Estimated Expiration: See Plans and Pricing

Patent: 050090410
Estimated Expiration: See Plans and Pricing

Spain

Patent: 12857
Estimated Expiration: See Plans and Pricing

Patent: 73639
Estimated Expiration: See Plans and Pricing

Patent: 24803
Estimated Expiration: See Plans and Pricing

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

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

Country Patent Number Title Estimated Expiration
Germany 60323155 See Plans and Pricing
Denmark 1587821 See Plans and Pricing
China 1747965 Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding See Plans and Pricing
World Intellectual Property Organization (WIPO) 2004056315 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VYNDAQEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1587821 C20120001 00050 Estonia See Plans and Pricing PRODUCT NAME: VYNDAQEL - TAFAMIDIS;REG NO/DATE: C(2011)8519 FINAL 16.11.2011
1587821 382 Finland See Plans and Pricing
1587821 126 5003-2012 Slovakia See Plans and Pricing PRODUCT NAME: TAFAMIDIS MEGLUMIN; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
1587821 6/2012 Austria See Plans and Pricing PRODUCT NAME: TAFAMIDIS; 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.