➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Moodys
McKinsey
Boehringer Ingelheim
McKesson
Harvard Business School
AstraZeneca

Last Updated: July 2, 2020

DrugPatentWatch Database Preview

VYNDAQEL Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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.

US ANDA Litigation and 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

< Available with Subscription >

  Start Trial

Summary for VYNDAQEL
International Patents:35
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 3
Drug Prices: Drug price information for VYNDAQEL
DailyMed Link:VYNDAQEL at DailyMed
Drug patent expirations by year for VYNDAQEL
Drug Prices for VYNDAQEL

See drug prices for VYNDAQEL

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 1
PfizerN/A

See all VYNDAQEL clinical trials

US Patents and Regulatory Information for VYNDAQEL

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 Y Y   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
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
>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 VYNDAQEL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1587821 1290005-6 Sweden   Start Trial PRODUCT NAME: TAFAMIDIS; REG. NO/DATE: EU/1/11/717/001 20111116
1587821 CR 2012 00006 Denmark   Start Trial PRODUCT NAME: TAFAMIDIS (SOM MEGLUMIN); REG. NO/DATE: EU/1/11/717/001 20111116
1587821 CA 2012 00006 Denmark   Start Trial
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 6/2012 Austria   Start Trial PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
1587821 2012/007 Ireland   Start Trial PRODUCT NAME: VYNDAQEL- TAFAMIDIS MEGLUMINE; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
McKinsey
Boehringer Ingelheim
McKesson
Harvard Business School
AstraZeneca

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.