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Last Updated: May 22, 2025

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
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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 one FDA Regulatory Exclusivity.

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

This potential generic entry date is based on patent 9,770,441.

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

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 9,770,441 ⤷  Try for Free Y Y ⤷  Try for Free
Foldrx Pharms VYNDAMAX tafamidis CAPSULE;ORAL 212161-001 May 3, 2019 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Foldrx Pharms VYNDAMAX tafamidis CAPSULE;ORAL 212161-001 May 3, 2019 RX Yes Yes 7,214,696 ⤷  Try for Free ⤷  Try for Free
Foldrx Pharms VYNDAMAX tafamidis CAPSULE;ORAL 212161-001 May 3, 2019 RX Yes Yes 7,214,695 ⤷  Try for Free Y Y ⤷  Try for Free
>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
Patent: FORMAS SÓLIDAS CRISTALINAS DE 6-CARBOXI-2-(3,5-DICLOROFENIL)-BENZOXAZOL
Estimated Expiration: ⤷  Try for Free

Australia

Patent: 15313875
Patent: Crystalline solid forms of 6-carboxy-2-(3,5-dichlorophenyl)-benzoxazole
Estimated Expiration: ⤷  Try for Free

Brazil

Patent: 2017003421
Patent: formas sólidas cristalinas de 6-carbóxi-2-(3,5-diclorofenil)-benzoxazol
Estimated Expiration: ⤷  Try for Free

Canada

Patent: 03194
Patent: FORMES CRISTALLINES SOLIDES DE 6-CARBOXY-2-(3,5-DICHLOROPHENYL)-BENZOXAZOLE (CRYSTALLINE SOLID FORMS OF 6-CARBOXY-2-(3,5-DICHLOROPHENYL)-BENZOXAZOLE)
Estimated Expiration: ⤷  Try for Free

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 for Free

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 for Free

Croatia

Patent: 0211834
Estimated Expiration: ⤷  Try for Free

Cyprus

Patent: 24843
Estimated Expiration: ⤷  Try for Free

European Patent Office

Patent: 91461
Patent: FORMES CRISTALLINES SOLIDES DU 6-CARBOXY-2-(3,5-DICHLOROPHÉNYL)-BENZOXAZOLE (CRYSTALLINE SOLID FORMS OF 6-CARBOXY-2-(3,5-DICHLOROPHENYL)-BENZOXAZOLE)
Estimated Expiration: ⤷  Try for Free

Patent: 77993
Patent: FORMES CRISTALLINES SOLIDES DU 6-CARBOXY-2-(3,5-DICHLOROPHÉNYL)-BENZOXAZOLE POUR L'UTILISATION COMME MÉDICAMENTS (CRYSTALLINE SOLID FORMS OF 6-CARBOXY-2-(3,5-DICHLOROPHENYL)-BENZOXAZOLE FOR USE AS A MEDICAMENT)
Estimated Expiration: ⤷  Try for Free

Hungary

Patent: 56583
Estimated Expiration: ⤷  Try for Free

Japan

Patent: 57525
Estimated Expiration: ⤷  Try for Free

Patent: 16065042
Patent: 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 (CRYSTALLINE SOLID FORMS OF 6-CARBOXY-2-(3,5-DICHLOROPHENYL)-BENZOXAZOLE)
Estimated Expiration: ⤷  Try for Free

Patent: 20055832
Patent: 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 (CRYSTALLINE SOLID FORMS OF 6-CARBOXY-2-(3,5-DICHLOROPHENYL)-BENZOXAZOLE)
Estimated Expiration: ⤷  Try for Free

Patent: 22024014
Patent: 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
Estimated Expiration: ⤷  Try for Free

Patent: 23134645
Patent: 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 (CRYSTALLINE SOLID FORMS OF 6-CARBOXY-2-(3,5-DICHLOROPHENYL)-BENZOXAZOLE)
Estimated Expiration: ⤷  Try for Free

Lithuania

Patent: 91461
Estimated Expiration: ⤷  Try for Free

Mexico

Patent: 17002954
Patent: FORMAS SOLIDAS CRISTIALINAS DE 6-CARBOXI-2-(3,5-DICLOROFENIL)-BENZ OXAZOL. (CRYSTALLINE SOLID FORMS OF 6-CARBOXY-2-(3,5-DICHLOROPHENYL)-BENZO XAZOLE.)
Estimated Expiration: ⤷  Try for Free

Poland

Patent: 91461
Estimated Expiration: ⤷  Try for Free

Portugal

Patent: 91461
Estimated Expiration: ⤷  Try for Free

Russian Federation

Patent: 92252
Patent: КРИСТАЛЛИЧЕСКИЕ ТВЕРДЫЕ ФОРМЫ 6-КАРБОКСИ-2-(3,5-ДИХЛОРФЕНИЛ)БЕНЗОКСАЗОЛА (CRYSTALLINE SOLID FORMS OF 6-CARBOXY-2-(3,5-DICHLOROPHENYL)BENZOXAZOLE)
Estimated Expiration: ⤷  Try for Free

Patent: 17107235
Patent: КРИСТАЛЛИЧЕСКИЕ ТВЕРДЫЕ ФОРМЫ 6-КАРБОКСИ-2-(3,5-ДИХЛОРФЕНИЛ)БЕНЗОКСАЗОЛА
Estimated Expiration: ⤷  Try for Free

Serbia

Patent: 634
Patent: ČVRSTI KRISTALNI OBLICI 6-KARBOKSI-2-(3,5-DIHLOROFENIL)-BENZOKSAZOLA (CRYSTALLINE SOLID FORMS OF 6-CARBOXY-2-(3,5-DICHLOROPHENYL)-BENZOXAZOLE)
Estimated Expiration: ⤷  Try for Free

Singapore

Patent: 201700958Y
Patent: CRYSTALLINE SOLID FORMS OF 6-CARBOXY-2-(3,5-DICHLOROPHENYL)-BENZOXAZOLE
Estimated Expiration: ⤷  Try for Free

Slovenia

Patent: 91461
Estimated Expiration: ⤷  Try for Free

South Korea

Patent: 2004059
Estimated Expiration: ⤷  Try for Free

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 for Free

Spain

Patent: 01785
Estimated Expiration: ⤷  Try for Free

Taiwan

Patent: 44902
Estimated Expiration: ⤷  Try for Free

Patent: 1613880
Patent: Crystalline solid forms of 6-carboxy-2-(3,5-dichlorophenyl)-benzoxazole
Estimated Expiration: ⤷  Try for Free

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
Spain 2901785 ⤷  Try for Free
Argentina 101778 FORMAS SÓLIDAS CRISTALINAS DE 6-CARBOXI-2-(3,5-DICLOROFENIL)-BENZOXAZOL ⤷  Try for Free
Russian Federation 2017107235 КРИСТАЛЛИЧЕСКИЕ ТВЕРДЫЕ ФОРМЫ 6-КАРБОКСИ-2-(3,5-ДИХЛОРФЕНИЛ)БЕНЗОКСАЗОЛА ⤷  Try for Free
China 101413143 Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VYNDAMAX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1587821 6/2012 Austria ⤷  Try for Free PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
1587821 382 Finland ⤷  Try for Free
1587821 1290005-6 Sweden ⤷  Try for Free PERIOD OF VALIDITY AFTER CORRECTION (FROM - UNTIL): 20231220 - 20261117
1587821 C01587821/01 Switzerland ⤷  Try for Free PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67083 09.03.2020
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for Vyndamax (Vyndaqel)

Introduction

Vyndamax, known as Vyndaqel outside the U.S., is a groundbreaking drug developed by Pfizer to treat the cardiac form of a rare disease called transthyretin amyloidosis (ATTR-CM). Here, we delve into the market dynamics and financial trajectory of this blockbuster medication.

Market Performance

Sales Figures

In the first quarter of 2024, Vyndaqel/Vyndamax achieved remarkable sales, generating $1.1 billion, a 25% increase over the consensus estimate of $900 million and a 66% boost from the first quarter of 2023[1][4]. This significant growth underscores the drug's strong market presence and continued uptake, particularly in the U.S. and certain European countries.

Drivers of Growth

Regulatory and Economic Factors

The growth of Vyndaqel/Vyndamax has been influenced by several key factors. The Inflation Reduction Act, which capped out-of-pocket costs for Medicare Part D beneficiaries, is expected to reduce patient spending by approximately $10,000, making the drug more accessible and contributing to its increased adoption[1].

Clinical Uptake

The drug's effectiveness in treating ATTR-CM has led to its widespread acceptance among healthcare providers. Continued strong uptake in the U.S. and Europe has been a major driver of its sales growth[1][3].

Competitive Landscape

Potential Competitors

Vyndaqel/Vyndamax faces potential competition from other pharmaceutical companies. BridgeBio Pharma is awaiting FDA approval for its drug acoramidis, which targets the same condition, with a decision expected by late November 2024. Alnylam Pharmaceuticals is also anticipating results from a study on its drug vutrisiran, which could compete with Vyndaqel if successful[1][4].

Market Positioning

Despite the looming competition, Vyndaqel/Vyndamax remains a blockbuster drug. Analysts project that it will maintain its market dominance, with estimates suggesting peak sales of around $5 billion to $6 billion, although this could be influenced by pricing strategies and other economic drivers[4].

Patent and Exclusivity

Patent Life

The basic product patent for Vyndaqel/Vyndamax is set to expire at the end of 2024 in the U.S. and in 2026 in Europe. Pfizer has filed for patent term extensions to protect its market exclusivity through 2028, which, if granted, would significantly impact the drug's financial trajectory[1].

Generic Competition

Several generic drugmakers have filed for U.S. approval of copycat versions, prompting Pfizer to sue them for patent infringement. The outcome of these legal battles will be crucial in determining the drug's future market share[1].

Financial Impact on Pfizer

Revenue Contribution

Vyndaqel/Vyndamax has become a critical component of Pfizer's revenue stream, especially as the company navigates declines in COVID-19 vaccine and antiviral drug sales. Excluding COVID-19 products, Pfizer's revenue grew 11% operationally in the first quarter of 2024, with Vyndaqel/Vyndamax contributing significantly to this growth[1][3].

Overall Financial Performance

Pfizer's total revenue in the first quarter of 2024 was $14.9 billion, down about 20% from the same period a year ago due to the decline in COVID-19 product sales. However, the strong performance of Vyndaqel/Vyndamax and other non-COVID products has helped mitigate this decline[1].

Industry Expert Insights

Analyst Perspectives

Analysts like Salim Syed from Mizuho Securities and Paul Matteis from Stifel have highlighted the drug's strong uptake and the potential impact of regulatory changes. They also emphasize the need for full data from competing drugs to assess the long-term competitive landscape[1][4].

Future Outlook

Market Expansion

The potential expansion of the patient population for ATTR-CM, driven by noninvasive diagnosis techniques, could further boost Vyndaqel/Vyndamax sales. However, pricing strategies and competition from new entrants will play a significant role in shaping its future market dynamics[4].

Pricing Considerations

The pricing of Vyndaqel/Vyndamax and its competitors will be a key factor. Currently, Alnylam's Amvuttra is priced higher but is expected to be adjusted downward, which could influence prescribing patterns and market share[4].

Key Takeaways

  • Strong Sales Performance: Vyndaqel/Vyndamax achieved $1.1 billion in sales in Q1 2024, exceeding expectations.
  • Regulatory Impact: The Inflation Reduction Act has increased accessibility, contributing to the drug's growth.
  • Competitive Landscape: Potential competition from BridgeBio and Alnylam, but Vyndaqel/Vyndamax is expected to maintain its market dominance.
  • Patent and Exclusivity: Pfizer is seeking patent term extensions to protect market exclusivity through 2028.
  • Financial Contribution: The drug is crucial for Pfizer's revenue, especially as COVID-19 product sales decline.

FAQs

What is Vyndamax used for?

Vyndamax is used to treat the cardiac form of transthyretin amyloidosis (ATTR-CM), a rare disease.

How much did Vyndaqel/Vyndamax generate in sales in Q1 2024?

Vyndaqel/Vyndamax generated $1.1 billion in sales in the first quarter of 2024.

What factors have contributed to the growth of Vyndaqel/Vyndamax?

The growth has been driven by continued strong uptake, regulatory changes like the Inflation Reduction Act, and increased accessibility.

Who are the potential competitors to Vyndaqel/Vyndamax?

BridgeBio Pharma and Alnylam Pharmaceuticals are potential competitors with drugs in development for the same condition.

What is the current patent status of Vyndaqel/Vyndamax?

The basic product patent is set to expire at the end of 2024 in the U.S. and in 2026 in Europe, with Pfizer seeking patent term extensions.

Sources

  1. Yahoo Finance: Pfizer's strong Vyndaqel sales draw attention to rare disease drug's ...
  2. Pfizer: PFIZER REPORTS FOURTH-QUARTER AND FULL-YEAR 2020 ...
  3. Pfizer: Pfizer Reports First-Quarter 2023 Results
  4. BioSpace: Alnylam Could Challenge Pfizer in ATTR-CM But Experts Want Full ...
Last updated: 2024-12-16

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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.