Last updated: February 16, 2026
What is the Drug with NDC 49884-0364?
The NDC 49884-0364 corresponds to Vyndaqel (tafamidis meglumine), approved by the FDA in 2019 for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). It is the first FDA-approved drug specifically for this indication.
Market Overview
Market Size and Growth Drivers
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Prevalence of ATTR-CM: The disease affects approximately 100,000-200,000 Americans, with underdiagnosis likely. Its prevalence increases with age, particularly over 60.
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Diagnosis Trends: Enhanced awareness and improved diagnostic techniques like cardiac MRI and nuclear scintigraphy increase detection rates.
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Competitive Landscape: Currently, tafamidis is the only approved medication for ATTR-CM. Other therapies are in development, including gene-silencing agents and stabilizers.
Key Competitors
| Drug |
Status |
Indication |
Launch Year |
| Vyndaqel (tafamidis) |
Approved (2019) |
ATTR-CM |
2019 |
| Acoramidis (AGT-186) |
Mid-stage clinical trials |
Stabilizer, potential future |
N/A |
| Inotersen (Tegsedi) |
Approved for hATTR polyneuropathy |
Nerve involvement |
2018 |
Market Adoption Factors
- Physician awareness has increased after FDA approval.
- Insurance coverage remains variable, affecting access and pricing.
- Cost-effectiveness analyses influence formulary decisions.
Current Pricing and Revenue Data
Wholesale Acquisition Cost (WAC)
- Original list price: approximately $225,000 per year per patient (per 2020 estimates).
- Insurance rebates and discounts can reduce net price.
Revenue Data
- In 2021, Pfizer's Vyndaqel generated over $500 million in global sales.
- U.S. sales constitute roughly 60-70% of total revenue in that period.
- The U.S. market saw growth of about 20% year over year between 2020 and 2022.
Price Projection Factors
Market Potential
- Estimated patient population: 50,000-100,000 in the U.S.
- Adoption rate: 20-30% within 3-5 years post-launch, progressing to 50-60% over a decade as diagnosis improves.
Pricing Trends
- Pricing is expected to remain stable with slight inflation adjustments.
- Payers’ negotiating power could pressure discounts.
- New formulations or partnerships may influence list prices.
Regulatory and Patent Outlook
- Patent expires in 2028. Patent challenges or biosimilar entry could reduce prices.
- Ongoing expansion into other indications, like ATTR-polyneuropathy, may influence pricing.
Future Price Projections
| Year |
Estimated Price (USD) |
Notes |
| 2023 |
$225,000 |
Current list price |
| 2025 |
$230,000 |
Moderate inflation + increased competition |
| 2030 |
$210,000 - $220,000 |
Potential biosimilar entries or generics by 2028 |
| 2035 |
$200,000 or lower |
Patent expiry, increased biosimilar competition |
Risks to Price and Market Growth
- Entry of biosimilars or generics post-patent expiry.
- Payer restrictions impacting reimbursement.
- Development of alternative therapies.
- Price sensitivity among the patient population.
Conclusion
Vyndaqel maintains high pricing due to its status as a first-in-class treatment and lack of alternatives. Market growth depends on increased diagnosis, clinician awareness, and payer acceptance. Price stability is likely within the near-term, with potential declines after patent expiration around 2028.
Key Takeaways
- The current list price for tafamidis (NDC 49884-0364) is approximately $225,000 annually.
- U.S. sales are nearing over half a billion dollars annually, with growth driven by increased diagnosis and awareness.
- Market expansion is constrained by diagnosis rates and payer negotiations.
- Price declines are probable after patent expiration in 2028 owing to biosimilar competition.
- Price projections suggest slight inflation until 2025, then possible decreases post-2030.
FAQs
Q1: How might biosimilar entry affect tafamidis pricing?
Biosimilars could reduce prices by 20-40% post-2028, depending on market adoption and rivalry intensity.
Q2: What other indications could influence future pricing?
Expansion into ATTR-polyneuropathy and broader amyloid diseases could justify premium pricing for new formulations.
Q3: How does insurance coverage impact the actual cost to patients?
Rebates, discounts, and insurance negotiations significantly lower out-of-pocket expenses compared to list prices.
Q4: What are the barriers to market penetration?
Slow diagnosis process, limited clinician familiarity, and payer restrictions constrain rapid adoption.
Q5: Will new therapies challenge tafamidis’s market dominance?
Yes, especially if they demonstrate higher efficacy, lower cost, or better safety profiles, which can influence prescribing habits.
References
[1] Pfizer. Vyndaqel (tafamidis meglumine). FDA Approval. 2019.
[2] IQVIA. Pharmaceuticals Market Data. 2022.
[3] EvaluatePharma. World Preview: Top 10 Pharma Trends, 2022.
[4] Bureau of Labor Statistics. Medical Price Index, 2022.
[5] MarketWatch. Cardiology Drug Market Forecast, 2021.
