Last updated: February 12, 2026
What Is the Current Market Status for Drug NDC 51407-0485?
The drug identified by NDC 51407-0485 is Entresto (sacubitril/valsartan). It is approved for treating heart failure with reduced ejection fraction (HFrEF). Since its FDA approval in 2015, Entresto's market penetration has increased steadily, driven by clinical guidelines endorsing its use over ACE inhibitors or ARBs alone.
Revenue for Entresto reached approximately $2.8 billion in 2022, representing a compound annual growth rate (CAGR) of 12% since 2018 [1]. The drug is marketed by Novartis, with global sales in over 80 countries competing against established therapies such as enalapril and candesartan.
Market dynamics are shaped by:
- Decreased reliance on traditional ACE inhibitors due to evidence of efficacy.
- Shifts toward early intervention in heart failure management.
- Increasing prevalence of heart failure, projected to reach 8.5 million cases in the U.S. by 2030 [2].
How Does the Competitive Landscape Influence Pricing?
Entresto's pricing in the United States averages around $470 per month (retail price). The drug holds a significant share of the HFrEF therapy market. Despite its high price, payers face increasing pressure to include it due to clinical benefits demonstrated in the PARADIGM-HF trial [3].
Competition from generic versions is pending primarily in Europe, where patent expiry could occur around 2027. Elsewhere, patent protections extend until 2030, limiting generic competition in the U.S. and similar markets.
Other therapies in development target alternate pathways:
- Valsartan-based generics.
- Novel peptide therapies addressing related pathways.
- Gene therapies for advanced heart failure.
What Are Price Projection Factors?
Pricing forecasts depend on multiple factors:
| Factor |
Impact |
| Patent Status |
U.S. patent expires around 2030; generics likely post-2032 |
| Competition |
Entry of generics reduces price by 40-60% in mature markets |
| Clinical Guidelines |
Continued endorsements push price stability or increases |
| Reimbursement Policies |
Price negotiations with payers influence net revenue |
What Are Future Price Trends?
- In the U.S., brand-name Entresto is expected to maintain stable list prices until patent expiry.
- Post-patent expiry, prices are projected to decline sharply—by roughly 50% or more [4].
- International markets with parallel import restrictions may retain higher prices until generic versions become available.
- New formulations or combination therapies could influence premium pricing for specific indications.
What Are Pricing Models We Anticipate?
In the near term (next 5 years), Entresto will likely sustain premium pricing due to:
- Validated clinical outcomes.
- Ongoing payer negotiations.
- Limited immediate generic competition.
Following patent expiration:
- Prices could decrease to 40-60% of current levels.
- Market share shifts toward generics or biosimilars, depending on approval and launch timelines.
- Price erosion will accelerate as generic manufacturers enter the market.
How Do Regulatory and Policy Factors Affect Future Prices?
Expanded healthcare coverage and value-based reimbursement initiatives may:
- impose price controls or negotiation caps.
- incentivize use of cost-effective options.
- influence the timing and extent of price reductions.
In Europe, health authorities can negotiate prices directly, often leading to discounts of 20-30% on initial list prices.
Conclusions and Strategic Positioning
- Pricing in the U.S. for Entresto remains near $470/month, reflecting continued clinical acceptance.
- Patent expiry around 2030 will likely trigger sharp cost reductions.
- International markets may see earlier price declines due to differing regulatory frameworks.
Investors and manufacturers should monitor:
- Patent statuses closely.
- Market entry of competitors.
- Changes in clinical guidelines and payer policies.
Key Takeaways
- Market value of NDC 51407-0485 is approximately $2.8 billion annually.
- World markets show varying timelines for patent expiry and generic entry.
- Price decreases post-patent are projected at 50% or higher.
- Premium pricing persists until patent expiry, driven by proven clinical benefits.
- Regulatory and reimbursement policies significantly influence future prices.
FAQs
1. When is the patent for Entresto expected to expire?
Patent protections in the U.S. are expected to expire around 2030, with European patent expiry possibly earlier due to regulatory procedures and patent litigation.
2. How will generic competition affect pricing?
Introduction of generics usually reduces prices by 40-60%. The impact depends on market uptake and payer policies.
3. Are there upcoming clinical trials that could influence the drug’s market?
Yes. Ongoing trials investigating expanded indications or combination therapies may extend market dominance or introduce new pricing dynamics.
4. What factors influence international pricing of Entresto?
Regulatory policies, drug patent laws, negotiation with health authorities, and import restrictions shape international prices.
5. How might healthcare policy changes impact future prices?
Price negotiation, reimbursement caps, and use of value-based pricing models could lower effective prices and restrict market access.
References
- IQVIA, "Market Detailed Report," 2022.
- American Heart Association, "Heart Failure Statistics," 2021.
- McMurray, J. J. V., et al., "Angiotensin–Neprilysin Inhibition versus Enalapril in Heart Failure," NEJM, 2014.
- EvaluatePharma, "Global Market Outlook," 2022.
