Last updated: February 21, 2026
What is NDC 50242-0074?
NDC 50242-0074 refers to a specific drug product listed in the National Drug Code (NDC) directory. Based on available data, this code corresponds to a branded pharmaceutical product, namely Vyndaqel (tafamidis meglumine), used for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). Vyndaqel is marketed by Pfizer, approved by the FDA since 2019.
Market Size and Demand Drivers
Patient Population
- Target condition: ATTR-CM affects approximately 50,000 patients in the U.S., with an estimated 20,000 diagnosed cases.
- Growth factors: Aging population, increased recognition of ATTR-CM, and improved diagnostic methods boost demand.
- Screening: Advances in imaging (e.g., Technetium-99m scans) have increased diagnosis rates.
Competitive Landscape
| Brand Name |
Active Ingredient |
Market Share |
Year Approved |
Key Competitors |
Price (2023) |
| Vyndaqel |
Tafamidis meglumine |
80% |
2019 |
Tolcapone, Inotersen (rare indications) |
$17,000/month |
| Relatives |
Other ATTR therapies |
20% |
N/A |
Not FDA-approved for cardiomyopathy |
N/A |
- Generic alternatives: None available as of 2023; patents protect Vyndaqel through 2027, with patent extensions possibly delaying generics.
- Biosimilars: Not applicable due to molecule complexity.
Market Trends
- Rapid adoption in cardiology centers.
- Investors anticipate growth due to expanding indications for ATTR-related diseases.
- R&D pipelines exploring similar compounds or additional indications.
Pricing Dynamics and Projections
Current Pricing
- Average wholesale price (AWP): $17,000/month per patient.
- Reimbursement: Usually through Medicare, private insurers, and Medicaid with negotiated discounts.
- Patient out-of-pocket: Can range from a few hundred to several thousand dollars, depending on insurance coverage.
Cost-Effectiveness and Payer Coverage
Multiple health economics studies validate Vyndaqel’s high price in light of its clinical benefits. Payers generally favor coverage due to the lack of alternative treatments for ATTR-CM.
Short-term Price Projection (Next 1-3 Years)
| Scenario |
Price Estimate |
Rationale |
| Stable |
$17,000/month |
Market remains stable with no new competitors. |
| Slight Increase |
Up to $18,000/month |
Inflation adjustments, increased demand, and expanded indications. |
| Price Reduction |
Down to $15,000/month |
Entry of biosimilar or generic competitors post-patent expiry (expected 2027). |
Long-term Outlook (Beyond 3 Years)
- Price decline likely following patent expiration around 2027.
- Entry of biosimilars or alternative therapies could reduce prices by 20-40%.
- Market expansion into Europe and Asia may influence pricing strategies, adding regional variability.
Future Market and Pricing Constraints
- Regulatory changes: New pricing controls or value-based reimbursement models could limit price escalation.
- Insurance policies: Insurers may push for discounts, impacting net prices.
- Pipeline: New drugs in late-stage development targeting ATTR-CM could lower the market share and pressure prices.
Key Takeaways
- NDC 50242-0074 (Vyndaqel) commands a high price driven by the rare disease population and lack of alternatives.
- The market is growing due to increased diagnosis and expanding indications.
- Price stability is expected until patent expiry around 2027, after which significant price competition could occur.
- Reimbursement, insurance coverage, and health economics will influence net prices.
- Developing biosimilars or alternative therapies remains a primary risk to future pricing.
FAQs
1. How long will Vyndaqel maintain market exclusivity?
Patent protections for Vyndaqel are expected to last until 2027, with possible extensions. Post-exclusivity, generic versions could significantly reduce prices.
2. What factors could influence the drug’s price over the next two years?
Market demand, insurance negotiations, regulatory policies, and supply chain factors will influence pricing stability.
3. Are biosimilars likely to enter the market?
No biosimilars currently exist for tafamidis. Entry depends on patent expiry and development progress, expected around 2027.
4. How does the competitive landscape affect price projections?
The absence of direct competitors enables Pfizer to maintain high prices. Entry of new therapies or generics would pressure prices downward.
5. What regional factors could impact global pricing?
Regulatory approvals, reimbursement policies, and healthcare infrastructure in Europe and Asia influence regional prices, which may differ from the U.S.
References
- Food and Drug Administration. (2019). FDA approves Vyndaqel for transthyretin amyloid cardiomyopathy. [FDA.gov]
- IQVIA. (2023). Pharmaceutical Pricing Data.
- MedlinePlus. (2022). Transthyretin Amyloid Cardiomyopathy.
- MarketWatch. (2023). Pfizer’s Vyndaqel revenue analysis.
- WHO. (2021). Global Disease Burden of Cardiomyopathies.
[1] U.S. Food and Drug Administration. (2019). FDA Approves Vyndaqel for Transthyretin Amyloid Cardiomyopathy.
[2] IQVIA. (2023). Pharmaceutical Market Data.
[3] MedlinePlus. (2022). Transthyretin Amyloid Cardiomyopathy Overview.
[4] MarketWatch. (2023). Pfizer Revenue from Vyndaqel.
[5] World Health Organization. (2021). Global Burden of Cardiomyopathies.
