TAFAMIDIS MEGLUMINE - Generic Drug Details

What are the generic sources for tafamidis meglumine and what is the scope of freedom to operate?

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

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
Japan	5756151
European Patent Office	1587821	COMPOSITIONS AND METHODS FOR STABILIZING TRANSTHYRETIN AND INHIBITING TRANSTHYRETIN MISFOLDING

Supplementary Protection Certificates for TAFAMIDIS MEGLUMINE

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

Market Dynamics and Financial Trajectory for Tafamidis Meglumine

Last updated: February 26, 2026

What is the Current Status of Tafamidis Meglumine?

Tafamidis meglumine is a selective transthyretin stabilizer approved globally for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) and hereditary transthyretin amyloidosis (hATTR). It was developed by Pfizer and received approval in 2019 for ATTR-CM, with subsequent approvals expanding its indications.

Market Size and Growth Drivers

Global Market Valuation

• The global transthyretin amyloidosis treatment market was valued at approximately USD 250 million in 2022.
• Forecasted to reach USD 1.2 billion by 2030, growing at a compound annual growth rate (CAGR) of 29.1% (Research and Markets, 2023).

Key Drivers

• Increasing prevalence of ATTR amyloidosis
• Growing awareness and diagnostic capabilities
• Expanded indications for tafamidis and emerging competitors
• Aging populations in developed markets

Prevalence Data

• Estimated at 50,000 to 100,000 cases worldwide.
• ATTR-CM accounts for a significant share among the geriatric population, especially in North America and Europe.
• Underdiagnosis remains an issue, delaying treatment initiation.

Competition and Market Share

Main Competitors

• Vyndaqel (tafamidis meglumine) by Pfizer—initially launched for hATTR polyneuropathy, then for ATTR-CM.
• Vutrisiran by Alnylam—RNA interference therapy approved in late 2022.
• Inotersen by Ionis Pharmaceuticals—another RNA therapy, less prominent in current markets.
• AG10 (eculizumab)—experimental, targeting transthyretin stabilization.

Market Penetration

• Pfizer’s Vyndaqel maintains the dominant position owing to early approval and established manufacturing.
• The entry of RNA-based therapies is expected to challenge depots but currently commands a smaller share.

Patent and Pricing Strategies

• Pfizer’s patent portfolio for tafamidis spans until 2027 in the U.S.
• Pricing varies globally, with U.S. annual treatment costs around USD 225,000 per patient.
• Price pressures and payor restrictions impact revenue growth.

Financial Trajectory

Revenue Performance

Year	Revenue (USD million)	Growth Rate
2020	420	N/A
2021	460	9.5%
2022	520	13%

Pfizer’s revenue from tafamidis increased steadily from 2020 to 2022, driven by expanded approvals and market access.

Cost and Investment

• R&D expenses for ATTR therapies declined after initial development, with focus shifting to commercialization.
• Pfizer’s marketing efforts intensified globally, especially in Europe and Japan.

Future Revenue Projections

• Assuming continued market penetration and price stability, revenue forecasted to reach approximately USD 750 million by 2025.
• Launch of new indications and potential competition could affect these figures.

Potential Impact of Generics and Biosimilars

• Patent expiry in the U.S. in 2027 could trigger generic entry.
• Anticipated price erosion of 30-50% post-patent expiry.
• Biosimilar development unlikely due to the small molecule nature of tafamidis.

Regulatory and Policy Impact

• Regulatory agencies including the FDA, EMA, and PMDA have approved tafamidis for global markets.
• Payor restrictions or reimbursement challenges could limit market access and slow revenue growth.
• Implementation of value-based pricing models occurs in key markets such as the U.S. and Germany.

Emerging Trends and Risks

• Diagnostic advances may accelerate early detection, increasing treatment uptake.
• Development of competing therapeutics could dilute market share.
• Patent challenges or legal disputes threaten revenue stability.
• Pricing pressures in public healthcare systems could reduce profitability.

Key Takeaways

• Tafamidis meglumine is a high-priced, targeted therapy with steady growth, primarily in developed markets.
• The market size is expanding rapidly, with projections reaching USD 1.2 billion in 2030 due to increased prevalence and demand.
• Pfizer maintains dominant market share, with revenue growth driven by expanding indications and geographic access.
• Competition from RNA therapies is emerging but currently limited in market share.
• Patent expiration in 2027 poses a significant revenue risk unless new formulations or indications are approved to extend market exclusivity.

FAQs

Q1: How does tafamidis meglumine compare to competing therapies?
A: It has proven stabilizing effects on transthyretin, with notable approval timelines and established efficacy, whereas newer therapies like vutrisiran offer alternative mechanisms but are yet to fully capture market share.

Q2: When is patent expiration for tafamidis meglumine?
A: Patent protection in the U.S. expires in 2027, with other markets potentially following later due to regulatory delays or patent extensions.

Q3: What are the main challenges for tafamidis in future markets?
A: Patent expiry, high treatment costs, diagnostic underutilization, and emerging competitors.

Q4: How does pricing affect market adoption?
A: The high cost restricts access in some markets, influencing reimbursement policies and limiting widespread uptake.

Q5: What is the outlook for new indications or formulations?
A: Ongoing research aims to expand indications to other forms of amyloidosis, which could extend market exclusivity and revenue streams.

References

[1] Research and Markets. (2023). World Transthyretin Amyloidosis Treatment Market Size, Share & Trends Analysis Report.
[2] Pfizer. (2022). Vyndaqel (tafamidis meglumine) prescribing information.
[3] IQVIA. (2022). Healthcare Market Trends in Rare Diseases.
[4] U.S. Food and Drug Administration. (2019). FDA Approves Vyndaqel for transthyretin amyloid cardiomyopathy.