VYNDAMAX Drug Patent Profile

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

Summary for VYNDAMAX

International Patents:	66
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	70
Patent Applications:	109
Drug Prices:	Drug price information for VYNDAMAX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VYNDAMAX
DailyMed Link:	VYNDAMAX at DailyMed

See drug prices for VYNDAMAX

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VYNDAMAX

Constraining patent/regulatory exclusivity:

9,770,441

NDA:

212161

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.

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		Y	Y
Foldrx Pharms	VYNDAMAX	tafamidis	CAPSULE;ORAL	212161-001	May 3, 2019		RX	Yes	Yes
Foldrx Pharms	VYNDAMAX	tafamidis	CAPSULE;ORAL	212161-001	May 3, 2019		RX	Yes	Yes	7,214,696
Foldrx Pharms	VYNDAMAX	tafamidis	CAPSULE;ORAL	212161-001	May 3, 2019		RX	Yes	Yes	7,214,695		Y	Y

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

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

Australia

Brazil

Canada

China

Croatia

Cyprus

European Patent Office

Hungary

Japan

Lithuania

Mexico

Poland

Portugal

Russian Federation

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

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
Argentina	101778	FORMAS SÓLIDAS CRISTALINAS DE 6-CARBOXI-2-(3,5-DICLOROFENIL)-BENZOXAZOL
Russian Federation	2017107235	КРИСТАЛЛИЧЕСКИЕ ТВЕРДЫЕ ФОРМЫ 6-КАРБОКСИ-2-(3,5-ДИХЛОРФЕНИЛ)БЕНЗОКСАЗОЛА
China	101413143	Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding

Supplementary Protection Certificates for VYNDAMAX

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

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