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Last Updated: April 24, 2024

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VYNDAMAX Drug Patent Profile


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When do Vyndamax patents expire, and when can generic versions of Vyndamax launch?

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

This drug has sixty-six patent family members in twenty-seven countries.

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

DrugPatentWatch® Generic Entry Outlook for Vyndamax

Vyndamax 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 August 31, 2035. This may change due to patent challenges or generic licensing.

There have been three 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 VYNDAMAX
Drug Prices for VYNDAMAX

See drug prices for VYNDAMAX

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

Paragraph IV (Patent) Challenges for VYNDAMAX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VYNDAMAX Capsules tafamidis 61 mg 212161 3 2023-05-03

US Patents and Regulatory Information for VYNDAMAX

VYNDAMAX is protected by three US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VYNDAMAX is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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 VYNDAMAX

Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

Crystalline solid forms of 6-carboxy-2-(3,5-dichlorophenyl)-benzoxazole
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF THE CARDIOMYOPATHY OF WILD TYPE OR HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS (ATTR-CM)

FDA Regulatory Exclusivity protecting VYNDAMAX

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

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: ⤷  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
Foldrx Pharms VYNDAMAX tafamidis CAPSULE;ORAL 212161-001 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 VYNDAMAX tafamidis CAPSULE;ORAL 212161-001 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 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
>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 VYNDAMAX

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 VYNDAMAX

When does loss-of-exclusivity occur for VYNDAMAX?

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

Argentina

Patent: 1778
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 15313875
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2017003421
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 03194
Estimated Expiration: ⤷  Try a Trial

China

Patent: 6715405
Patent: 6‑羧基‑2‑(3,5‑二氯苯基)苯并噁唑的结晶固体形式 (Crystalline solid forms of 6-carboxy-2-(3,5-dichlorophenyl)-benzoxazole)
Estimated Expiration: ⤷  Try a Trial

Patent: 5368313
Patent: 6-羧基-2-(3,5-二氯苯基)苯并噁唑的结晶固体形式 (Crystalline solid forms of 6-carboxy-2-(3, 5-dichlorophenyl) benzoxazole)
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0211834
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 24843
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 91461
Estimated Expiration: ⤷  Try a Trial

Patent: 77993
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 56583
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 57525
Estimated Expiration: ⤷  Try a Trial

Patent: 16065042
Estimated Expiration: ⤷  Try a Trial

Patent: 20055832
Estimated Expiration: ⤷  Try a Trial

Patent: 22024014
Estimated Expiration: ⤷  Try a Trial

Patent: 23134645
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 91461
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 17002954
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 91461
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 91461
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 92252
Estimated Expiration: ⤷  Try a Trial

Patent: 17107235
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 634
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201700958Y
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 91461
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2004059
Estimated Expiration: ⤷  Try a Trial

Patent: 170040314
Patent: 6-카르복시-2--벤족사졸의 결정질 고체 형태 (6--2-35-- CRYSTALLINE SOLID FORMS OF 6-CARBOXY-2-35-DICHLOROPHENYL-BENZOXAZOLE)
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 01785
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 44902
Estimated Expiration: ⤷  Try a Trial

Patent: 1613880
Estimated Expiration: ⤷  Try a Trial

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 VYNDAMAX around the world.

Country Patent Number Title Estimated Expiration
Portugal 3191461 ⤷  Try a Trial
Japan 2022024014 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 ⤷  Try a Trial
European Patent Office 1587821 COMPOSITIONS AND METHODS FOR STABILIZING TRANSTHYRETIN AND INHIBITING TRANSTHYRETIN MISFOLDING ⤷  Try a Trial
Japan 7357525 ⤷  Try a Trial
Canada 2510455 COMPOSITIONS AND METHODS FOR STABILIZING TRANSTHYRETIN AND INHIBITING TRANSTHYRETIN MISFOLDING ⤷  Try a Trial
Japan 5756151 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2004056315 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VYNDAMAX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1587821 C 2012 004 Romania ⤷  Try a 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 126 5003-2012 Slovakia ⤷  Try a Trial PRODUCT NAME: TAFAMIDIS MEGLUMIN; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
1587821 C01587821/01 Switzerland ⤷  Try a Trial PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67083 09.03.2020
1587821 91935 Luxembourg ⤷  Try a Trial 91935, EXPIRES: 20261116
1587821 CA 2012 00006 Denmark ⤷  Try a Trial
1587821 SPC/GB12/009 United Kingdom ⤷  Try a Trial PRODUCT NAME: TAFAMIDIS, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE MEGLUMINE SALT; REGISTERED: UK 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
>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.