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 December 19, 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:

7,214,695

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 patent 7,214,695.

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
Spain	2312857
Australia	2010201263
European Patent Office	1988397	COMPOSITIONS AND USES FOR STABILISING TRANSTHYRETIN AND INHIBITING TRANSTHYRETIN MISFOLDING
South Africa	200505034

Supplementary Protection Certificates for VYNDAQEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1587821	CA 2012 00006	Denmark
1587821	6/2012	Austria		PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
1587821	C300516	Netherlands		PRODUCT NAME: TAFAMIDIS, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER TAFAMIDIS MEGLUMINE ZOUT; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
1587821	SPC/GB12/009	United Kingdom		PRODUCT NAME: TAFAMIDIS, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE MEGLUMINE SALT; REGISTERED: UK EU/1/11/717/001 20111118

Market Dynamics and Financial Trajectory for VYNDAQEL (Tafamidis)

Last updated: November 7, 2025

Introduction

VYNDAQEL (generic name: tafamidis) is a groundbreaking pharmaceutical agent developed to combat transthyretin amyloid cardiomyopathy (ATTR-CM) and familial amyloid polyneuropathy (FAP). Approved by regulatory authorities worldwide, particularly by the U.S. Food and Drug Administration (FDA) in 2019, tafamidis has carved a niche in the niche but rapidly expanding landscape of rare and orphan diseases. Its market trajectory is influenced by a myriad of factors ranging from epidemiological trends to regulatory changes, pricing strategies, competitive dynamics, and clinical advancements.

This analysis offers a comprehensive overview of the market dynamics shaping tafamidis’s commercial success and projects its financial trajectory over the coming years, offering crucial insights for stakeholders.

Pharmacological Profile and Therapeutic Significance

Tafamidis functions as a selective stabilizer of transthyretin (TTR) tetramers, preventing their misfolding and subsequent aggregation—a key pathological driver in amyloidosis. The molecule’s innovative mechanism addresses a core pathological process, differentiating it from symptomatic treatments.

The drug’s approval for ATTR-CM marked a milestone in the treatment of this complex, traditionally underdiagnosed, cardiac disorder characterized by amyloid deposits leading to heart failure. The severity and progressive nature of ATTR-CM make tafamidis’s role indispensable; as such, it is positioned as a first-in-class therapy.

Market Size and Epidemiological Trends

The primary drivers of tafamidis’s market are its target patient populations:

• Transthyretin Amyloid Cardiomyopathy (ATTR-CM): Prevalence estimates indicate approximately 200,000–300,000 patients globally, with a significant underdiagnosis offset by rising awareness and screening initiatives [1].

• Familial Amyloid Polyneuropathy (FAP): Considered rare, with about 10,000–20,000 cases worldwide, predominantly in endemic regions such as Portugal, Sweden, and Japan [2].

Modern diagnostic techniques, including cardiac MRI and nuclear scintigraphy, enhance early detection, expanding the identifiable patient base. Moreover, increased screening in high-risk populations contributes to near-term market growth.

Regulatory and Reimbursement Landscape

Tafamidis’s pathway has been characterized by proactive regulatory engagement leading to accelerated approvals, including those in the EU, Japan, and the U.S. (labeled as a breakthrough therapy). Payers globally have begun to reimburse the drug, recognizing its clinical value, although reimbursement policies vary significantly across geographies.

Pricing strategies reflect the medicine's orphan drug status and high unmet need. The U.S. list price hovers around $225,000 annually, positioning tafamidis among the higher-cost therapies but justified by its substantial clinical benefits [3].

Competitive Dynamics

Tafamidis remains the pioneering therapy in this space, but competition is intensifying:

• Emerging Therapeutics: Several pipeline agents, including gene-silencing drugs (e.g., inotersen, patisiran) and other small molecules, aim at similar or complementary targets [4].

• Biosimilars and Generics: As patent protections (primarily composition patents and method of use patents) expire, generic versions or biosimilars may undercut pricing and erode market share.

• Combination Therapy: Future developments may see tafamidis used alongside other agents, creating new market segments.

Market Penetration and Adoption

Tafamidis’s adoption has been robust in regions with established diagnostic pathways and reimbursement frameworks. In the U.S., Prescribing information, expanded indications, and health economics data have facilitated wider access.

However, challenges include:

• Diagnosis Delays: Amyloidosis remains underdiagnosed in many territories, limiting the immediate market potential.

• Cost and Affordability: High price points impede access in some markets, influencing overall revenue.

Financial Trajectory and Revenue Projections

The financial outlook for tafamidis indicates sustained growth:

• 2019–2022: Post-approval, sales surged from approximately $150 million to over $1 billion globally, supported by expanded indications and increased awareness [5].

• 2023–2025: Market analysts predict compound annual growth rates (CAGR) around 20–25%, driven by:

  • Increased diagnosis rates
  • Geographic expansion (e.g., emerging markets)
  • Approvals for additional indications (e.g., early-stage ATTR-CM)
  • Patent protections and exclusivity periods providing pricing power

• Long-term Outlook: Once patent exclusivity ends (expected around 2027–2029), the entry of biosimilars may diminish revenues unless new formulations or indications are approved.

Regulatory and Scientific Developments

Recent pivotal trials like ATTRibute and ATTRact showcased tafamidis’s efficacy, further reinforcing its market position. Upcoming therapies pending approval could influence the trajectory by providing alternatives or combination options.

Additionally, genetic and biomarker-driven approaches will refine patient selection, potentially expanding the addressable market and improving outcomes, thus enhancing revenue flow.

Market Risks and Opportunities

Risks:

• Pricing pressures from biosimilar entrants and healthcare payers.

• Delayed diagnosis limiting market penetration.

• Clinical setbacks or failure of pipeline compounds.

Opportunities:

• Expanded indications (e.g., early-stage ATTR-CM or polyneuropathy).

• Market penetration in underserved regions with emerging screening initiatives.

• Partnerships with payers and advocacy groups to foster early diagnosis and reimbursement.

Key Factors Influencing Financial Outlook

Factor	Impact	Outlook
Epidemiological Demand	Positive	Expanding patient base with better screening
Pricing and Reimbursement	Variable	Influences revenue potential regionally
Patent and Market Exclusivity	Critical	Determines duration of premium pricing
Clinical Development Pipeline	Encouraging	Potential for new indications to broaden market
Competitive Landscape	Worsening	Biosimilar entry could compress margins

Conclusion

VYNDAQEL (tafamidis) stands as a pioneering drug with significant market traction driven by its clinical efficacy and orphan drug designation. The product’s market dynamic is characterized by robust growth metrics, contingent upon continued innovation, expanded indications, and strategic pricing. Its financial trajectory appears favorable over the medium term but faces headwinds from emerging competitors, pricing pressures, and market access challenges.

Long-term success will hinge upon proactive engagement with regulators, payers, and the clinical community to broaden its reach, while navigating patent and biosimilar entry timelines prudently. Stakeholders must monitor epidemiological trends, advances in diagnostics, and scientific breakthroughs to optimize the drug’s commercial and therapeutic impact.

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Key Takeaways

• Tafamidis has established itself as a first-in-class therapy in the rare amyloidosis space, with revenues scaling rapidly since approval.

• The expanding prevalence of ATTR-CM, aided by improved diagnostics, underpins sustained demand growth.

• Strategic pricing, early diagnosis programs, and regulatory support are pivotal to optimizing the commercial potential.

• The future market will be shaped by pipeline developments, biosimilar entry, and advancements in genetic-based therapies.

• Stakeholders must balance market expansion efforts with challenges posed by affordability, competition, and regulatory pathways.

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FAQs

1. What is the primary therapeutic target of VYNDAQEL (tafamidis)?
Tafamidis stabilizes transthyretin (TTR) tetramers, preventing their dissociation and subsequent amyloid fibril formation, which is central to transthyretin amyloidosis.

2. How does the expiration of patents affect tafamidis’s market?
Patent expiration around 2027–2029 will allow biosimilar entrants, likely leading to price reductions and potential market share erosion unless new indications or formulations are approved.

3. Are there any emerging therapies that threaten tafamidis’s market position?
Yes, drugs like gene-silencing agents (e.g., inotersen, patisiran) and other TTR stabilizers are in development, some of which may compete or complement tafamidis depending on regulatory outcomes.

4. What are the main obstacles to increasing tafamidis’s adoption globally?
Key challenges include underdiagnosis of amyloidosis, high treatment costs, variable reimbursement policies, and the need for clinician awareness.

5. What future developments could enhance tafamidis's market prospects?
Approval of additional indications, early diagnosis initiatives, combination therapy strategies, and entry into new geographical markets are poised to boost its market presence.

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Sources:
[1] Day, S. (2022). Epidemiology of transthyretin amyloid cardiomyopathy. Heart Failure Clinics.
[2] Maurer, M. S., et al. (2018). ATTR amyloidosis clinical overview. JACC.
[3] Pfizer. (2022). VYNDAQEL Pricing and Reimbursement Data.
[4] Gillmore, J. D., et al. (2020). Advances in amyloidosis therapeutics. Nature Reviews Drug Discovery.
[5] IQVIA. (2023). Global Sales Data for Tafamidis.