Last updated: February 22, 2026
What is the Drug with NDC 10337-0450?
The National Drug Code (NDC) 10337-0450 refers to Youvaris (vericiguat) tablets, produced by Merck. It is indicated for the treatment of chronic heart failure with reduced ejection fraction (HFrEF). Approved by the FDA in January 2021, Youvaris is an oral soluble guanylate cyclase stimulator. It offers an alternative to existing heart failure therapies.
Market Size and Demand Drivers
Current Market Size
The U.S. heart failure therapy market exceeds $5 billion annually. Vericiguat entered this market as a niche product, primarily targeting patients with HFrEF with high risk of hospitalization or mortality.
Key Demand Factors
- Prevalence of HFrEF: Over 6 million Americans have heart failure, with HFrEF comprising around 50% of cases.
- Treatment Gap: Despite available therapies, hospitalization rates remain high, driving demand for new agents like vericiguat.
- Guideline Inclusion: The 2022 AHA/ACC/HFSA guidelines highlight vericiguat as a secondary option for certain patient groups with persistent symptoms despite standard therapy.
Competitive Landscape
Major competitors include:
- Beta-blockers
- ACE inhibitors/ARBs
- ARNIs (e.g., sacubitril/valsartan)
- SGLT2 inhibitors (e.g., dapagliflozin, empagliflozin)
Vericiguat’s niche is as an add-on therapy for high-risk, symptomatic HFrEF patients.
Pricing Trends and Projections
Current Pricing Data
Price per 30-tablet bottle (e.g., 2.5 mg or 5 mg dosage) varies, with average wholesale prices (AWP) around $825 to $950.
| Attribute |
Data |
| Average Wholesale Price (AWP) |
$850 per 30-count |
| Estimated Wholesale Acquisition Cost (WAC) |
$700 to $750 |
| Median Retail Price (Post-Rebate) |
$820 |
Pricing Dynamics
- Launch Price: When launched in early 2021, initial wholesale acquisition cost was approximately $850 per month.
- Discounts & Rebates: Payers usually negotiate rebates, reducing net prices by 20-30%.
- Formulary Positioning: As a new entry, initial placement is moderate, with strategic increases expected as clinical benefits become established.
Price Projection (2023–2027)
Price reductions are expected in response to:
- Increased generic or biosimilar competition (if applicable)
- Price erosion driven by payer negotiations
- Market penetration strategies
Projected average wholesale price by 2027 is forecasted at $750–$800 per 30-day supply, considering discount trends, payer pressure, and competitive dynamics.
Revenue Projections
Assuming a gradual uptake:
- Year 1 (2023): Approximately 15,000 patients, generating around $250 million in sales.
- Year 3 (2025): Uptake increases to 35,000 patients, with sales reaching $600–700 million.
- Year 5 (2027): Saturation at 50,000 patients, with sales surpassing $800 million annually.
The growth rate depends heavily on FDA label expansion, payer acceptance, and real-world evidence of improved outcomes.
Regulatory and Reimbursement Outlook
Approval Status
- FDA approved in January 2021 for reducing risk of cardiovascular death and heart failure hospitalization.
- Pending expansion of indications and label updates to include broader heart failure populations.
Reimbursement
- Coverage hinges on formulary placement, clinical guidelines, and payer negotiations.
- As a novel agent, initial reimbursement may be limited but expected to improve with accumulating clinical data.
Market Entry Strategy Considerations
- Partnerships with payers and providers to maximize formulary placement
- Clinical evidence supporting improved outcomes over standard care
- Educational campaigns targeting cardiologists and heart failure specialists
Key Takeaways
- The heart failure market continues to grow, driven by patient prevalence and unmet needs.
- Youvaris has a premium pricing position, with prices around $850/month; moderate reductions are forecasted.
- Revenue growth depends on clinical adoption, payer acceptance, and competition.
- The next few years will determine if vericiguat secures a significant niche in heart failure therapy.
FAQs
1. What factors influence the price of NDC 10337-0450?
Pricing is impacted by manufacturing costs, market demand, payer negotiations, competition, and clinical value in treating high-risk heart failure patients.
2. When will prices for Youvaris decline significantly?
Prices are likely to trend downward post-2023, especially if generics or biosimilars enter the market or if payer discounts increase.
3. How does Youvaris compare with other heart failure drugs in terms of price?
It is priced higher than many standard therapies due to being a new molecular entity. Standard heart failure drugs, such as ACE inhibitors or beta-blockers, typically cost significantly less.
4. What is the potential market size for Youvaris?
Targeted at high-risk HFrEF patients, the potential U.S. market covers approximately 3 million patients, with adoption rates estimated to reach 25–50% over five years.
5. What are the primary barriers to price growth for vericiguat?
Barriers include existing competition, payer restrictions, limited clinical data beyond current indication, and the high cost of new heart failure therapies.
References
[1] FDA. (2021). FDA approves Vericiguat for heart failure.
[2] MarketWatch. (2022). Heart failure drugs market size & forecast.
[3] IQVIA. (2022). U.S. prescription drug price trends.
[4] American Heart Association. (2022). Heart failure guideline updates.
[5] Institute for Clinical and Economic Review. (2022). Heart failure therapies cost-effectiveness analyses.
