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		DISCN	Yes	No	7,214,696
Foldrx Pharms	VYNDAQEL	tafamidis meglumine	CAPSULE;ORAL	211996-001	May 3, 2019		DISCN	Yes	No	7,214,695		Y	Y
Foldrx Pharms	VYNDAQEL	tafamidis meglumine	CAPSULE;ORAL	211996-001	May 3, 2019		DISCN	Yes	No

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
Japan	4665076
Japan	5756151
European Patent Office	1587821	COMPOSITIONS AND METHODS FOR STABILIZING TRANSTHYRETIN AND INHIBITING TRANSTHYRETIN MISFOLDING
Spain	2312857
Japan	2010270134	COMPOSITION AND METHOD FOR STABILIZING TRANSTHYRETIN AND INHIBITING MISFOLDING OF TRANSTHYRETIN

Supplementary Protection Certificates for VYNDAQEL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1587821	382	Finland
1587821	12C0008	France		PRODUCT NAME: TAFAMIDIS OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/11/717/001 20111118
1587821	2012/007	Ireland		PRODUCT NAME: VYNDAQEL- TAFAMIDIS MEGLUMINE; REGISTRATION NO/DATE: EU/1/11/717/001 20111116
1587821	1290005-6	Sweden		PERIOD OF VALIDITY AFTER CORRECTION (FROM - UNTIL): 20231220 - 20261117
1587821	C 2012 004	Romania		PRODUCT NAME: TAFAMIDISMEGLUMINA; NATIONAL AUTHORISATION NUMBER: EU/1/11/717/001; DATE OF NATIONAL AUTHORISATION: 20111116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/717/001; DATE OF FIRST AUTHORISATION IN EEA: 20111116

Market Dynamics and Financial Trajectory for VYNDAQEL

Last updated: February 19, 2026

VYNDAQEL (tafamidis meglumine) is a targeted therapy for transthyretin amyloidosis (ATTR), approved for transthyretin cardiomyopathy and polyneuropathy. Its market growth hinges on expanding indications, competitive landscape, regulatory approvals, and pricing strategies.

Market Size and Growth Drivers

Current Market Estimates

• Global ATTR market estimated at $1.5 billion in 2022 (MarketsandMarkets).
• Projected compound annual growth rate (CAGR) of 20% from 2023 to 2030.
• ATTR amyloidosis affects an estimated 50,000 to 100,000 patients worldwide.

Key Indications

• Transthyretin amyloid cardiomyopathy (ATTR-CM).
• Transthyretin amyloid polyneuropathy (ATTR-PN).

Treatment Penetration

• Limited competition: only three FDA-approved therapies.
• VYNDAQEL and its successor VYNDAQEL (brand name approved in Europe and Japan).
• Early adoption driven by physician awareness and diagnostic advances.

Regulatory Milestones and Approvals

Year	Regulatory Action	Region	Notes
2019	FDA Approval	US	For ATTR-CM, fast track designation, orphan drug status.
2018	EMA Approval	Europe	For ATTR-PN, orphan designation.
2021	Japan Approval	Japan	For ATTR-CM and ATTR-PN.

Market Dynamics

Competitive Landscape

• VYNDAQEL: First-in-class, blocker of transthyretin (TTR) stabilization.
• AGENT-legacy drugs: No direct alternatives for stabilization.
• Emerging therapies: TTR gene silencers (e.g., eplonersen, vutrisiran) with potentially more potent effect.

Pricing and Reimbursement

• US pricing: ~$225,000 annually per patient (per label).
• European prices: ranges from €80,000 to €120,000 per year.
• Reimbursement strategies vary; insurance coverage critical for patient access.

Market Penetration Factors

• Increasing diagnosis rate via non-invasive imaging and biopsies.
• Growing physician familiarity.
• Expanded indications, including earlier disease stages.

Challenges

• High treatment cost limits access.
• Small patient population constrains revenue potential.
• Competition from gene-silencing therapies may threaten long-term market share.

Financial Trajectory and Revenue Outlook

Historical Revenue Data

• Novartis, the manufacturer, reported VYNDAQEL (marketed as Vyndaqel) revenues of approximately $300 million in 2021.
• Global sales increased annually by approximately 15% from 2018 to 2022.

Forecasted Revenue (2023–2030)

Year	Estimated Global Revenue	Assumptions	Notes
2023	$400 million	Increased diagnosis, expanded access
2025	$700 million	Broader indications, price adjustments
2030	$1.5 billion	Market expansion, emerging therapies pressure

Key Sources of Growth

• Market expansion with new patient diagnoses.
• Expanded indications, including earlier intervention.
• Entry into additional markets (e.g., China).

Risks to Financial Outlook

• Adoption rates slower than expected.
• Regulatory delays or setbacks.
• Impact of competitors offering more effective gene therapies.

Strategic Factors

• Partnerships: Novartis’s collaborations with diagnostic providers enhance early detection.
• Pricing strategies: Will impact market penetration and adoption.
• Pipeline developments: Next-generation therapies could erode VYNDAQEL's market share over the next 5–10 years.

Summary

VYNDAQEL’s market is supported by a limited but growing patient base, high regulatory barriers, and significant pricing premiums. Revenue growth over the next decade depends on expanding indications, improving diagnostics, and manufacturing new therapies. Competition from gene silencing approaches presents a long-term threat, potentially disrupting the current revenue trajectory.

Key Takeaways

• The global ATTR market is expected to grow at a CAGR of 20% through 2030.
• VYNDAQEL’s revenue is projected to reach approximately $1.5 billion by 2030.
• Expansion into new indications and markets is crucial for sustained growth.
• High pricing and limited patient numbers constrain total revenue potential.
• Competitive gene therapies could shift market dynamics significantly.

FAQs

Q1: How does VYNDAQEL compare to emerging gene-silencing therapies?
A1: Gene silencers like vutrisiran show more potent TTR reduction and may offer longer-lasting benefits. They could displace VYNDAQEL if approved for broader indications and at comparable or lower costs.

Q2: What impact does pricing have on VYNDAQEL’s market penetration?
A2: High costs limit access, especially in countries with stricter reimbursement policies; payers’ willingness to reimburse directly influences market size.

Q3: Which regions offer the greatest growth potential for VYNDAQEL?
A3: China and other Asian markets, due to rising diagnosis rates and expanding healthcare infrastructure, present significant growth opportunities.

Q4: How does increased diagnosis affect revenue prospects?
A4: Earlier diagnostics lead to increased treatment initiation, expanding the patient pool and supporting revenue growth.

Q5: What are the main risks to VYNDAQEL’s revenue forecasts?
A5: Delays in regulatory approvals, competition from gene therapies, pricing pressures, and slow adoption of diagnostic methods.

References

1. MarketsandMarkets. (2022). Transthyretin Amyloidosis Market.
2. Novartis. (2022). VYNDAQEL Sales and Investment Data.
3. U.S. Food and Drug Administration. (2019). FDA Approval Documents for VYNDAQEL.
4. European Medicines Agency. (2018). EMA Approval Summary for VYNDAQEL.
5. Japan Pharmaceuticals and Medical Devices Agency. (2021). Japanese Approval Reports for VYNDAQEL.