Last updated: July 29, 2025
Introduction
Understanding the market dynamics and pricing trends for the drug associated with National Drug Code (NDC) 00832-1672 is essential for stakeholders spanning pharmaceutical companies, healthcare providers, and investors. This comprehensive analysis evaluates current market conditions, competitive landscape, reimbursement factors, regulatory environment, and future pricing trajectories specific to this drug.
Product Profile and Regulatory Status
NDC 00832-1672 corresponds to Entresto (sacubitril/valsartan), manufactured by Novartis. Approved by the FDA in July 2015, Entresto is indicated for reducing the risk of cardiovascular death and hospitalization due to heart failure with reduced ejection fraction (HFrEF). Its mechanism combines neprilysin inhibition with angiotensin receptor blockade, positioning it as a key therapy within the heart failure treatment paradigm.
Given its pivotal role in chronic heart failure management, Entresto maintains a significant market share among renin-angiotensin system inhibitors. Its regulatory approval across various jurisdictions, including EU and Japan, further bolsters its global presence.
Market Overview
Market Size and Penetration
The heart failure drug market is projected to reach approximately $7.2 billion by 2025 globally, with Entresto accounting for a substantial portion of this due to its patent-protected status and clinical efficacy[1]. The global prevalence of heart failure exceeds 64 million people, with increasing incidence driven by aging populations and chronic cardiovascular risk factors.
In the U.S., the drug's adoption has been robust, supported by multiple guideline updates endorsing its use for HFrEF, such as the 2016 guidelines from the American College of Cardiology and the American Heart Association. Market penetration reached over 50% among eligible patients by 2022[2].
Competitive Landscape
Entresto's primary competitors include traditional ACE inhibitors and ARBs like enalapril and valsartan. However, their widespread generic availability and lower cost diminish direct competition. The only significant alternative branded agent in similar indications is BiDil (isosorbide dinitrate/hydralazine), but its use is more niche.
Generic versions of sacubitril/valsartan are anticipated to enter the market following patent expiration, which could considerably affect pricing and sales volumes.
Pricing Trends and Reimbursement Landscape
Current Price Structure
As of recently, the average wholesale price (AWP) for Entresto is approximately $470–$480 per month for the branded formulation in the U.S. retail setting. Actual reimbursements vary based on insurance, pharmacy benefit managers (PBMs), and formularies.
Reimbursement and Cost-Effectiveness
Reimbursement policies significantly influence market access. Medicare Part D covers Entresto, with patient copayments often ranging from $10 to $50 per month, depending on plans. High drug costs initially posed barriers, but subsequent demonstration of clinical benefits—namely reduction in hospitalizations—has supported favorable formulary placements.
Cost-effectiveness analyses report incremental cost-effectiveness ratios (ICERs) around $50,000–$70,000 per quality-adjusted life year (QALY), positioning Entresto as a cost-effective therapy within its class[3].
Trend Toward Price Competition
Patent expiration and the entry of biosimilars or generics are poised to drive prices downward. The forecast suggests generic sacubitril/valsartan could reduce drug prices by 50–70% within 3–5 years of market entry, aligned with trends seen in other specialty drugs.
Future Pricing Projections
Impact of Patent Expiry and Biosimilar Entry
The patent for Entresto is expected to expire around 2029–2030. Once generic alternatives are available, price reductions are anticipated. Historically, brand-to-generic price drops average around 60%, contingent on market competition and regulatory approval of generics or biosimilars.
Market-Oriented Price Trajectory
- Short-term (next 1–2 years): Stability or slight price reductions due to market maturation but minimal impact until generics are approved.
- Mid-term (3–5 years post-patent expiry): Significant price declines, with estimates of $150–$200 per month for generic equivalents.
- Long-term (beyond 2030): Prices could stabilize at 20–30% of current branded levels, especially if biosimilars or alternative therapies gain market share.
Pricing Influences
Factors influencing future prices include:
- Reimbursement policies emphasizing cost containment.
- Insurance coverage trends favoring generics.
- Physician prescribing behavior driven by efficacy and cost considerations.
- Market demand elasticity among heart failure populations.
Regulatory and Policy Factors
The FDA’s ongoing initiatives on biosimilar acceptance and price transparency policies may accelerate generic penetration. Additionally, managed care organizations' inclusion of cost-effective options will pressure prices downward.
Global regulatory harmonization and regional patent laws will influence timing and pricing dynamics outside the U.S., notably in the EU, Japan, and emerging markets.
Market Growth and Price Projection Summary
| Time Frame |
Expectation |
Price Trend |
Market Dynamics |
| Next 1–2 years |
Stable with marginal reductions |
Maintains at ~$470–$480 per month |
Strong market share held by brand |
| 3–5 years post-patent |
Entry of generics begins, prices decline |
Drop of 50–70% expected |
Increased competition, reimbursement shifts |
| Beyond 2030 |
Price stabilization at lower levels |
Level at ~$150–$200 per month (generic) |
Market consolidation and new therapies |
Key Takeaways
- Entresto (NDC 00832-1672) remains a dominant player in the HFrEF market, bolstered by strong clinical data and guideline endorsements.
- Pricing is currently high, with AWP around $470–$480 per month, supported by brand exclusivity, but future secular decline is inevitable once patents expire.
- Generic entry post-2029–2030 will likely reduce prices by up to 70%, significantly impacting revenues.
- Healthcare policy trends and reimbursement practices will further influence market access and pricing strategies.
- Proactive planning for patent cliffs and generic competition will be necessary for stakeholders to optimize profitability and market positioning.
FAQs
1. When will generic versions of sacubitril/valsartan become available?
Patent expiry is anticipated around 2029–2030, at which point generics are likely to enter the market, leading to substantial price reductions.
2. How does the current pricing of Entresto compare globally?
Pricing varies globally due to regulatory and reimbursement differences, with higher prices in the U.S. and more negotiated rates in countries with national health services.
3. What factors influence the reimbursement of Entresto in the U.S.?
Insurance coverage, formulary placement, cost-effectiveness assessments, and negotiated discounts significantly impact reimbursement levels.
4. How might biosimilar development impact the heart failure treatment landscape?
While biosimilars for sacubitril/valsartan are not yet approved, their emergence could further decrease prices and expand access.
5. Are there ongoing efforts to develop cheaper alternatives for heart failure therapy?
Yes, ongoing research into novel pathways and cheaper drug formulations continues, with the goal of improving affordability and patient outcomes.
References
[1] MarketWatch. “Global Heart Failure Drugs Market Size, Share & Trends Analysis Report” (2022).
[2] American Heart Association. "Heart Failure Statistics." 2022.
[3] Neumann, et al. "Cost-effectiveness of Sacubitril-Valsartan in Heart Failure." Journal of Cardiology, 2021.
