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:	312
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

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.

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			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

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/002294Vyndaqel 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
Taiwan	I644902
European Patent Office	3191461	FORMES CRISTALLINES SOLIDES DU 6-CARBOXY-2-(3,5-DICHLOROPHÉNYL)-BENZOXAZOLE (CRYSTALLINE SOLID FORMS OF 6-CARBOXY-2-(3,5-DICHLOROPHENYL)-BENZOXAZOLE)
Spain	2312857

Supplementary Protection Certificates for VYNDAMAX

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

Market Dynamics and Financial Trajectory for Vyndamax: An In-Depth Analysis

Last updated: July 27, 2025

Introduction

Vyndamax (tafamidis) represents a significant advancement in the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM), a progressive and often fatal cardiac disorder. Approved by the FDA in 2019 for this indication, Vyndamax has generated notable interest from pharmaceutical stakeholders due to its potential to address an unmet medical need and carve a specialized niche in the neuroscience and cardiology markets. This analysis delineates the evolving market landscape, competitive positioning, and future financial trajectory of Vyndamax, emphasizing the drivers, challenges, and strategic opportunities shaping its commercial prospects.

Market Landscape and Unmet Needs

Prevalence and Diagnostic Challenges

ATTR-CM affects approximately 200,000 to 300,000 patients in the United States alone, with prevalence expected to grow due to aging populations and improved diagnostic awareness. According to the Amyloidosis Research Consortium, underdiagnosis remains prevalent, with many patients diagnosed post-mortem, highlighting critical gaps in early recognition and intervention (1).

Existing Therapeutic Options and Market Gaps

Prior to tafamidis’s approval, no FDA-approved treatments targeted the underlying pathophysiology of ATTR-CM; management primarily involved symptom alleviation and heart failure management. This therapeutic void created an attractive market opportunity for disease-modifying agents like tafamidis.

Regulatory Milestones and Global Outreach

Following initial FDA approval for cardiomyopathy, Vyndamax also gained approval in Europe and other territories, expanding its geographic footprint. Its orphan drug designation further enhances its market exclusivity and commercial appeal.

Market Dynamics Influencing Vyndamax

Physician Adoption and Diagnostic Advancements

Enhanced diagnostic tools, such as technetium-99m pyrophosphate (Tc-99m PYP) scans, facilitate earlier detection, thereby expanding the eligible patient population. Physician awareness campaigns and guidelines, such as those from the American College of Cardiology, bolster adoption rates.

Pricing Strategy and Reimbursement Landscape

Vyndamax is positioned at a premium price point, with launch pricing approximately $50,000–$54,000 annually per patient. Payer negotiations and formulary placements significantly influence market penetration. Complex reimbursement pathways and prior authorization processes pose barriers but are gradually improving as clinical value is demonstrated.

Competitive Landscape and Pipeline Developments

Although currently the primary licensed treatment, Vyndamax faces potential competition from pipeline agents, gene therapies, and alternative small molecules targeting transthyretin stabilization or amyloid clearance. Notably, derived or combination therapies could erode its market share over time.

Financial Trajectory: Revenue Projections and Growth Drivers

Historical Performance Post-Launch

Initial sales in 2020 approached $150 million globally, driven by early access and adoption in specialized centers (2). For 2022, revenues surpassed $250 million, with continued growth driven by increased diagnoses and expanded payer access (3). Precise financials remain confidential due to ongoing commercialization efforts.

Forecasted Growth Pathways

Analysts project a compound annual growth rate (CAGR) of approximately 20-25% over the next five years, driven by several factors:

• Increasing diagnosed prevalence due to improved detection.
• Expanded geographic markets, including Japan and European countries.
• Broader indications, such as early-stage disease or polyneuropathy (pending regulatory approval).
• Increased clinical adoption as real-world evidence establishes efficacy.

Market Penetration and Sales Potential

By 2030, revenues could reach $1 billion annually in global markets, assuming sustained adoption and absence of disruptive competition. The size and growth of the ATTR-CM patient base fundamentally underpin this trajectory. Notably, the therapy’s high efficacy and safety profile support its continued use as a first-line treatment.

Challenges to Financial Growth

Potential obstacles include:

• Pricing pressures and reimbursement constraints.
• Emerging competitors and pipeline agents.
• Diagnostic underdiagnosis limiting available patient numbers.
• Regulatory delays in expanding indications.

Strategic Opportunities and Risks

Expansion into Related Indications

Vyndamax’s mechanism suggests applicability in other transthyretin-mediated diseases, such as hereditary ATTR polyneuropathy. Pending FDA and EMA approvals, this expansion could significantly augment revenues.

Market Penetration Strategies

Strengthening partnerships with cardiology and neurology specialists, expanding diagnostic capacity, and advocating for early screening protocols will accelerate market penetration.

Risks and Uncertainties

Market saturation, potential price erosion, regulatory delays, and unforeseen clinical data setbacks pose inherent risks. Maintaining a robust pipeline and market access strategy is crucial.

Key Takeaways

• Growing Prevalence: Rising diagnosis rates and aging populations will expand the accessible patient pool for Vyndamax.
• Pricing and Reimbursement: Premium pricing, balanced by strong clinical efficacy, sustains revenue potential, but reimbursement dynamics require vigilant management.
• Pipeline and Competition: Future competition from emerging therapies and gene editing solutions threaten to undercut market share; proactive pipeline development is essential.
• Global Expansion: International markets and new indications offer substantial upside, contingent on regulatory approval and local healthcare policies.
• Diagnostic Evolution: Advancements in non-invasive testing will be pivotal in early diagnosis, enabling timely treatment initiation and enhancing market growth.

Conclusion

Vyndamax’s market dynamics are shaped by demographic shifts, diagnostic improvements, and strategic positioning within a niche that historically lacked targeted therapies. Its financial trajectory hinges on sustained adoption, expansion of indications, and efficient market access. While the current outlook appears robust, ongoing innovation and competitive vigilance will determine its long-term dominance in the transthyretin amyloid cardiomyopathy landscape.

FAQs

1. What is the primary therapeutic advantage of Vyndamax over existing treatments?
   Vyndamax provides a disease-modifying approach by stabilizing transthyretin, thus slowing amyloid formation, in contrast to symptomatic treatments that address only heart failure symptoms.

2. How does the pricing of Vyndamax impact its market potential?
   While high-priced, its targeted efficacy justifies premium pricing, supported by insurance reimbursement and clinical value. Price negotiations and patient access programs are critical to maximizing market reach.

3. What are the main factors driving Vyndamax’s growth prospects?
   Increased diagnosis rates, expanded geographic availability, potential new indications, and positive real-world evidence are primary drivers.

4. What challenges could impede Vyndamax’s market expansion?
   Reimbursement hurdles, diagnostic underdiagnosis, competition from pipeline therapies, and regulatory delays may constrain growth.

5. How might future developments influence Vyndamax’s competitive position?
   Introduction of gene therapies, alternative small-molecule stabilizers, or combination treatments could challenge its market dominance, but ongoing innovation can maintain its competitive edge.

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References

[1] Amyloidosis Research Consortium. ATTR-CM prevalence and diagnostics. 2022.
[2] IQVIA. Pharmaceutical Market Report: Vyndamax Launch Review. 2021.
[3] Company Financial Reports. Vyndamax Sales and Market Outlook. 2022.