VYNDAQEL Drug Patent Profile

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 two patents protecting this drug and one Paragraph IV challenge.

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 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 May 3, 2026. This may change due to patent challenges or generic licensing.

There have been two 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 VYNDAQEL

International Patents:	35
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	4
Drug Prices:	Drug price information for VYNDAQEL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VYNDAQEL
What excipients (inactive ingredients) are in VYNDAQEL?	VYNDAQEL excipients list
DailyMed Link:	VYNDAQEL at DailyMed

See drug prices for VYNDAQEL

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) 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:

211996

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

Sponsor	Phase
Pfizer	Phase 4
Pfizer	Phase 1
Pfizer

See all VYNDAQEL clinical trials

Paragraph IV (Patent) Challenges for VYNDAQEL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VYNDAQEL	Capsules	tafamidis meglumine	20 mg	211996	1	2023-05-03

US Patents and Regulatory Information for VYNDAQEL

VYNDAQEL is protected by two US patents and one FDA Regulatory Exclusivity.

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.

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	7,214,696
Foldrx Pharms	VYNDAQEL	tafamidis meglumine	CAPSULE;ORAL	211996-001	May 3, 2019		RX	Yes	Yes	7,214,695		Y	Y
Foldrx Pharms	VYNDAQEL	tafamidis meglumine	CAPSULE;ORAL	211996-001	May 3, 2019		RX	Yes	Yes

Expired US Patents for VYNDAQEL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Foldrx Pharms	VYNDAQEL	tafamidis meglumine	CAPSULE;ORAL	211996-001	May 3, 2019	8,168,663
Foldrx Pharms	VYNDAQEL	tafamidis meglumine	CAPSULE;ORAL	211996-001	May 3, 2019	8,653,119

International Patents for VYNDAQEL

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

Country	Patent Number	Title	Estimated Expiration
South Africa	200505034	Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding
Spain	2312857
European Patent Office	1988397	COMPOSITIONS AND USES FOR STABILISING TRANSTHYRETIN AND INHIBITING TRANSTHYRETIN MISFOLDING
South Korea	20050090410
Portugal	1587821

Supplementary Protection Certificates for VYNDAQEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1587821	1290005-6	Sweden		PERIOD OF VALIDITY AFTER CORRECTION (FROM - UNTIL): 20231220 - 20261117
1587821	382	Finland
1587821	CA 2012 00006	Denmark
1587821	C20120001 00050	Estonia		PRODUCT NAME: VYNDAQEL - TAFAMIDIS;REG NO/DATE: C(2011)8519 FINAL 16.11.2011
1587821	91935	Luxembourg		91935, EXPIRES: 20261116

Market Dynamics and Financial Trajectory for Vyndaqel

Introduction to Vyndaqel

Vyndaqel, also known as tafamidis, is a medication developed by Pfizer to treat the cardiac form of a rare disease called transthyretin amyloidosis (ATTR-CM). This drug has been making significant waves in the pharmaceutical industry due to its strong sales performance and the growing demand for treatments of rare diseases.

Market Size and Growth Projections

The global Vyndaqel market is anticipated to experience robust growth over the coming years. As of 2022, the market size was valued at approximately $1.5 billion, and it is projected to reach $9.2 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 15.8% from 2023 to 2032[3][5].

Key Growth Factors

Disease Prevalence and Awareness

The increasing recognition and awareness of transthyretin amyloidosis among healthcare providers and the public are driving the demand for effective treatments like Vyndaqel. Improved diagnostics have led to a growing patient pool, contributing to the market's expansion[3].

Advancements in Medical Research

Ongoing research in the field of amyloidosis and RNA-based therapies has paved the way for innovative treatments. Scientific breakthroughs and clinical trials are expanding treatment options, which in turn are contributing to market growth[3].

Regulatory Approvals

Vyndaqel’s approval by regulatory agencies in various regions has provided a solid foundation for its market presence. Regulatory support ensures patient safety, enhances the drug’s credibility, and improves its accessibility[3].

Strategic Collaborations

Partnerships between pharmaceutical companies, such as Pfizer and Akcea Therapeutics, have enabled the development, distribution, and marketing of Vyndaqel. These collaborations streamline the drug’s availability to a broader patient population[3].

Patient Access and Support Programs

Initiatives to improve patient access, affordability, and adherence to Vyndaqel therapy are crucial. Support programs and financial assistance options help patients receive the treatment they need, further boosting market growth[3].

Global Expansion

Efforts to expand Vyndaqel’s availability in different regions and countries are increasing its market reach. Securing regulatory approvals in new markets and addressing unmet medical needs are key strategies[3].

Financial Performance of Vyndaqel

Recent Sales Figures

In the first quarter of 2024, Vyndaqel delivered impressive sales figures, exceeding Wall Street forecasts. The drug generated $1.1 billion in revenue between January and March, a 25% increase over the consensus estimate of just over $900 million. This performance was significantly higher than the $686 million in sales during the same period in the previous year[1].

Operational Revenue Growth

Excluding contributions from Pfizer's COVID-19 vaccine (Comirnaty) and antiviral drug (Paxlovid), the company's operational revenue grew 11% in the first quarter of 2024. Vyndaqel was a key driver of this growth, with its sales increasing by 39% operationally compared to the prior year[2][4].

Impact of Healthcare Policies

The Inflation Reduction Act, which capped out-of-pocket costs for people covered by Medicare Part D, is expected to reduce out-of-pocket spending by about $10,000 for patients using Vyndaqel. This policy change has likely boosted the uptake of the drug, particularly in the U.S.[1].

Patent and Market Exclusivity

Patent Life and Generic Competition

The basic product patent for Vyndaqel is set to expire at the end of 2024 in the U.S. and in 2026 in Europe. Several generic drugmakers have filed for U.S. approval of copycat versions, prompting Pfizer to sue them for patent infringement. Pfizer is also seeking to extend the drug’s market exclusivity through 2028 via pending patent term extension requests[1].

Competitive Landscape

The looming patent expiration and potential generic competition have significant implications for Pfizer and its competitors. Companies like BridgeBio Pharma and Alnylam Pharmaceuticals are awaiting FDA approvals for their own treatments in the same condition, which could potentially compete with Vyndaqel in the future[1].

Regional Market Dynamics

Largest and Fastest-Growing Markets

Europe is currently the largest market for Vyndaqel, while the Asia-Pacific region is expected to be the fastest-growing market over the forecast period. This growth is driven by increasing awareness, improved diagnostics, and expanding access to the drug in these regions[5].

Impact of COVID-19

Healthcare Spending and Budgets

The COVID-19 pandemic had a mixed impact on the Vyndaqel market. While it presented budget constraints in healthcare systems, it also accelerated the adoption of telemedicine and remote monitoring technologies, which could positively impact Vyndaqel’s market by facilitating remote consultations and monitoring[3].

Increased Focus on Rare Diseases

The pandemic heightened awareness of the importance of addressing rare diseases and fostering healthcare resilience. This increased focus could lead to greater emphasis on treatments like Vyndaqel, contributing to its market growth[3].

Key Takeaways

• Strong Sales Performance: Vyndaqel has outperformed expectations, with $1.1 billion in sales in the first quarter of 2024.
• Market Growth: The global Vyndaqel market is projected to reach $9.2 billion by 2032, growing at a CAGR of 15.8%.
• Regulatory and Policy Support: Regulatory approvals and favorable healthcare policies, such as the Inflation Reduction Act, are driving market growth.
• Competitive Landscape: The drug faces potential competition from generic versions and new treatments from other pharmaceutical companies.
• Regional Dynamics: Europe is the largest market, while the Asia-Pacific region is the fastest-growing.

FAQs

What is Vyndaqel used for?

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

How much did Vyndaqel generate in sales in the first quarter of 2024?

Vyndaqel generated $1.1 billion in sales in the first quarter of 2024, exceeding Wall Street forecasts.

What is the projected market size of Vyndaqel by 2032?

The global Vyndaqel market is projected to reach $9.2 billion by 2032.

What are the key factors driving the growth of the Vyndaqel market?

Key factors include increasing disease prevalence and awareness, advancements in medical research, regulatory approvals, strategic collaborations, and favorable healthcare policies.

When is the basic product patent for Vyndaqel set to expire?

The basic product patent for Vyndaqel is set to expire at the end of 2024 in the U.S. and in 2026 in Europe.

Sources

1. Yahoo Finance: Pfizer's strong Vyndaqel sales draw attention to rare disease drug's growth[1].
2. Pfizer: Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance[2].
3. Custom Market Insights: Global Vyndaqel Market Size Reach $9.2 Billion 2032[3].
4. Pfizer: Pfizer Reports First-Quarter 2024 Results[4].
5. Custom Market Insights: Global Vyndaqel Market Size, Trends, Share, Forecast 2032[5].

Last updated: 2024-12-16