Tafamidis meglumine - Generic Drug Details

What are the generic sources for tafamidis meglumine and what is the scope of patent protection?

Tafamidis meglumine is the generic ingredient in one branded drug marketed by Foldrx Pharms and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tafamidis meglumine has thirty-five patent family members in seventeen countries.

One supplier is listed for this compound.

Summary for tafamidis meglumine

International Patents:	35
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	26
Clinical Trials:	10
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tafamidis meglumine
What excipients (inactive ingredients) are in tafamidis meglumine?	tafamidis meglumine excipients list
DailyMed Link:	tafamidis meglumine at DailyMed

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

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 tafamidis meglumine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Qilu Pharmaceutical Co., Ltd.	PHASE4
Pfizer	Phase 4
Pfizer	Phase 1

See all tafamidis meglumine clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for tafamidis meglumine

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for TAFAMIDIS MEGLUMINE

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 tafamidis meglumine

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

Expired US Patents for tafamidis meglumine

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

International Patents for tafamidis meglumine

Country	Patent Number	Title	Estimated Expiration
Japan	4665076
Spain	2373639
China	101413143	Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding
China	1747965	Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding
Brazil	0317463	Métodos de triar para um composto que evita ou reduz a dissolução de um tetrâmero de transtiretina e de tratar uma doença amilóide transtiretina

Supplementary Protection Certificates for tafamidis meglumine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1587821	CR 2012 00006	Denmark		PRODUCT NAME: TAFAMIDIS (SOM MEGLUMIN); REG. NO/DATE: EU/1/11/717/001 20111116
1587821	C20120001 00050	Estonia		PRODUCT NAME: VYNDAQEL - TAFAMIDIS;REG NO/DATE: C(2011)8519 FINAL 16.11.2011
1587821	CA 2012 00006	Denmark
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
1587821	6/2012	Austria		PRODUCT NAME: TAFAMIDIS; REGISTRATION NO/DATE: EU/1/11/717/001 20111116

Market Dynamics and Financial Trajectory for Tafamidis Meglumine

Last updated: July 28, 2025

---

Introduction

Tafamidis meglumine, marketed under the brand name Vyndaqel®, represents a pivotal advancement in the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) and polyneuropathy (ATTR-PN). As a TTR stabilizer, it is the first FDA-approved drug targeting the underlying pathophysiology of these rare, life-threatening systemic disorders. Its market dynamics and financial trajectory reflect a confluence of clinical efficacy, regulatory developments, competitive landscape, and evolving healthcare economics.

---

Market Overview

The global market for tafamidis meglumine is primarily driven by the rising prevalence of transthyretin amyloidosis (ATTR), especially as diagnostic capabilities improve. Historically classified as a rare disease, ATTR has garnered increased attention due to its underdiagnosis and significant mortality burden. The increasing aging population, particularly in North America and Europe, accelerates the demand for disease-modifying therapies. According to recent estimates, the global ATTR market is projected to grow substantially, with a Compound Annual Growth Rate (CAGR) of approximately 15-20% over the next decade (1).

The uptake of tafamidis is contingent on its approval status, pricing strategies, healthcare provider awareness, and patient access pathways. As of early 2023, the drug is approved in multiple regions, including the US, EU, and Japan, with broader geographical expansion underway.

---

Regulatory Landscape and Market Entry

Tafamidis received FDA approval in 2019 for ATTR-CM and subsequently for ATTR-PN in Europe and other jurisdictions. Its approval marked a milestone as a first-in-class targeted therapy for ATTR, transitioning the disease management paradigm from symptomatic treatments to disease modification. Regulatory expansion grants it exclusivity periods that influence short- and long-term market shares.

The FDA approval was based on pivotal studies, including the ATTR-ACT trial, which demonstrated a significant reduction in all-cause mortality and cardiovascular-related hospitalizations (2). These compelling clinical outcomes underpin confidence among clinicians and payers, enhancing adoption rates.

Pricing, Reimbursement, and Market Access

Tafamidis commands premium pricing, with wholesale acquisition costs (WAC) in the U.S. exceeding $225,000 annually for ATTR-CM. Payers and healthcare systems evaluate such prices against clinical benefits, cost-effectiveness analyses, and budget impact models. Early analyses suggest that while high costs limit access initially, cost offsets from reduced hospitalizations and disease progression offer a persuasive value proposition (3).

Market access is dynamically evolving, influenced by negotiations, formulary placements, and HTA (Health Technology Assessment) recommendations. Countries with nationalized healthcare systems implement cost-effectiveness thresholds, shaping reimbursement landscapes.

---

Competitive Dynamics and Market Penetration

Though tafamidis dominates its niche, competition from other TTR stabilizers and gene-silencing modalities is emerging. Compounds such as acoramidis (AG10), designed to improve upon the efficacy and safety profile of tafamidis, are in advanced clinical phases. Small molecule destabilizers and RNA interference (RNAi) therapies, like patisiran, form part of the broader therapeutic universe targeting ATTR.

The competitive landscape influences tafamidis’s financial trajectory by impacting market share, pricing strategies, and potential for combination therapies. Moreover, increasing awareness and early diagnosis, driven by advancing biomarker detection and genetic screening, expand the target patient pool, supporting sustained revenue growth.

Patents and Market Exclusivity

Tafamidis benefits from patent protection extending into the late 2020s or early 2030s, offering a period of market exclusivity. This protection induces high revenues, but imminent patent expirations could open opportunities for biosimilars or generics, challenging pricing power and market dominance.

---

Financial Trajectory and Revenue Projections

Pharmaceutical companies, notably Pfizer and Eikonok, oversee the commercial deployment of tafamidis. Based on sales reports, global revenues approached $1.2 billion in 2022, reflecting robust adoption in key markets (4). The revenue growth is expected to persist, driven by:

• Expanded geographic footprint, including approvals in emerging markets.
• Increasing diagnosed prevalence owing to better awareness and screening.
• Broadened indications, such as early-stage ATTR.

Analysts project that by 2030, global sales could reach $3-5 billion, assuming continued growth and market penetration. These forecasts are contingent on competitive dynamics, regulatory environment, and healthcare policy shifts.

Potential for Price Adjustments

Given the high cost, payers might implement tiered or value-based pricing arrangements, potentially influencing revenue recognition. Outcomes-based payment models could foster access while safeguarding payer budgets.

Risks and Uncertainties

Market contraction could ensue from emerging competitors, biosimilars, or generic entries. Clinical setbacks, safety concerns, or reimbursement pressures also pose risks to revenue stability. Conversely, novel combination approaches or indications may open additional revenue streams.

---

Future Outlook

The future of tafamidis meglumine is intertwined with ongoing clinical trials examining its efficacy across broader populations and earlier disease stages. The adoption of genetic testing and improved diagnostic algorithms can catalyze earlier intervention, transforming the market’s size and financial potential.

Further, policy trends favoring high-value, targeted therapies and personalized medicine support a favorable environment for tafamidis’s sustained financial performance. Strategic partnerships, licensing, and market expansion efforts are likely to amplify revenue streams.

Key Opportunities:

• Expansion into emerging markets with generics or biosimilars.
• Development of next-generation TTR stabilizers or combination therapies.
• Enhanced patient stratification enabling personalized treatment, increasing efficacy, and cost-effectiveness.

---

Conclusion

Tafamidis meglumine’s market dynamics are characterized by strong clinical validation, high pricing power, and expanding indications, underpinning a lucrative financial trajectory. Its success is contingent upon continuous clinical innovation, regulatory navigation, and the evolving healthcare ecosystem's receptivity to high-cost, targeted therapies. Stakeholders must remain vigilant to competitive developments, patent landscapes, and reimbursement mechanics to optimize its market potential.

---

Key Takeaways

• Growing Market Demand: An increasing prevalence of ATTR due to aging populations and improved diagnosis expands tafamidis’s market potential.
• Premium Pricing & Reimbursement: High valuation is sustained through clinical efficacy; however, reimbursement negotiations remain pivotal.
• Competitive Landscape: Emerging therapies and biosimilars threaten market share, but existing patent protections afford significant revenue streams.
• Regulatory Expansion & Broadened Indications: Additional approvals and early-stage indications promise increased sales.
• Risks & Opportunities: Market shares will hinge on clinical, regulatory, and economic factors; innovation and market access strategies are essential.

---

FAQs

1. What drives the high cost of tafamidis meglumine?
Its high cost reflects extensive R&D investment, clinical validation, and the rarity of the disease, which limits patient volume but necessitates high per-patient pricing to recoup investment.

2. How does tafamidis compare to emerging therapies for ATTR?
While tafamidis is the first approved TTR stabilizer, emerging agents, such as acoramidis and RNAi therapies, aim to offer improved efficacy, safety, or convenience, potentially impacting its market share.

3. What is the outlook for generic versions of tafamidis?
Patent expirations expected in the late 2020s could lead to biosimilar or generic competition, reducing prices and expanding access but potentially decreasing exclusivity-driven revenues.

4. How does expanding indications influence tafamidis’s financial trajectory?
Broader indications, including earlier disease stages, could significantly enlarge the treated population, driving revenue growth, provided regulatory and reimbursement pathways are favorable.

5. What role do diagnostic advances play in tafamidis’s market growth?
Enhanced diagnostic tools facilitate early detection, enabling timely intervention with tafamidis, which can improve outcomes and expand the total addressable market.

---

References

1. GlobalData. Transthyretin Amyloidosis Market Report. 2022.
2. Maurer MS, et al. "Tafamidis for transthyretin amyloid cardiomyopathy: A randomized clinical trial." JAMA, 2018.
3. Morrison M, et al. "Cost-effectiveness of tafamidis for transthyretin amyloid cardiomyopathy." Orphanet Journal of Rare Diseases, 2020.
4. Pfizer. Annual Report 2022.