Last updated: July 30, 2025
Introduction
The drug with NDC 00517-0799 refers to Entresto (sacubitril/valsartan), marketed by Novartis Pharmaceuticals. As a groundbreaking medication approved by the FDA in 2015, Entresto has revolutionized the management of heart failure with reduced ejection fraction (HFrEF). This analysis evaluates current market dynamics, competitive landscape, regulatory environment, pricing trends, and future projections to inform stakeholders and decision-makers.
Pharmacological Profile and Therapeutic Significance
Entresto combines sacubitril, a novel neprilysin inhibitor, with valsartan, an angiotensin receptor blocker. This dual mechanism of action enhances natriuretic peptide activity while suppressing the renin-angiotensin system, leading to improved clinical outcomes for patients with HFrEF. Its clinical efficacy exceeds that of traditional ACE inhibitors or ARBs, as demonstrated in the PARADIGM-HF trial, which showed reductions in mortality and hospitalization rates.
Market Landscape
Current Market Size
The heart failure therapeutics market is substantial, with 6.5 million Americans living with heart failure, and an estimated 1 million diagnosed with HFrEF [1]. Globally, the market is projected to reach USD 3.7 billion by 2026, exhibiting a CAGR of roughly 8% (2021–2026) [2].
Key Competitors
Entresto’s primary competitors include:
- ACE inhibitors: Enalapril, Ramipril
- ARBs: Losartan, Valsartan (as monotherapy)
- Other novel agents: ARNIs in developmental stages, such as Omecamtiv Mecarbil
Market Penetration
Since its launch, Entresto's adoption has grown steadily, driven by guidelines endorsing its use as first-line therapy for suitable HFrEF patients. Data suggest over 70% of eligible patients are prescribed Entresto in high-income markets, notably the U.S. and Europe [3].
Pricing Trends and Reimbursement Landscape
Current Pricing
In the United States, the average wholesale price (AWP) for Entresto is approximately USD 550–600 per month for a 100 mg/103 mg dose, with variations based on dosing and pharmacy discounts [4].
Reimbursement Policies
Part B and Part D coverage influences patient access. Coverage expansions under Medicare and commercial insurers have facilitated broader adoption. However, high out-of-pocket costs remain a barrier for some populations.
Price Evolution
Since launch, brand pricing has stabilized, with moderate increases aligned with inflation and supply chain costs. The advent of biosimilars is unlikely given the molecule's complexity, which provides Novartis a degree of pricing power.
Regulatory Environment and Patent Landscape
Patent Protections
Entresto's key patents extend until approximately 2030, safeguarding market exclusivity and enabling pricing power. Patent expirations could open opportunities for generics or biosimilars, potentially diminishing prices.
Regulatory Approvals
Beyond the U.S., Entresto holds approvals in over 100 countries, broadening market access. Regulatory barriers and approval times remain moderate but could accelerate in emerging markets.
Market Drivers
- Clinical Guideline Endorsements: Updated guidelines recommend Entresto as the first-line agent in HFrEF, boosting prescriptions.
- Expanding Indications: Ongoing research explores its utility in conditions like HF with preserved ejection fraction (HFpEF) and hypertension.
- Growing HFrEF Prevalence: Aging populations globally will increase demand.
- Healthcare Cost Savings: Reduced hospitalizations improve cost-effectiveness, incentivizing insurers and payers.
Constraints and Challenges
- Pricing Concerns: High cost may limit access in low-to-middle-income regions.
- Competitive Approaches: Other ARNI or novel therapies could challenge Entresto’s market share.
- Patent Expiry Risks: Generic or biosimilar entrants post-2030 could significantly reduce prices.
Future Price Projections
Based on current trends, regulatory environment, and competitive landscape:
| Year |
Price Estimate (USD/month) |
Rationale |
| 2023 |
USD 575–600 |
Stabilization post-launch gains, inflation adjustments |
| 2025 |
USD 580–620 |
Moderate increase, similar to inflation; potential payor pressure |
| 2030 |
USD 450–500 (post-patent expiry) |
Possible decline with generics entry |
| 2035 |
USD 300–400 (post-patent expiry) |
Greater competition, biosimilar market presence |
It is plausible that prior to patent expiration, market prices will remain relatively stable, supported by clinical efficacy and guideline endorsements. Post-expiry, significant price erosion is expected, akin to other branded biologics.
Emerging Trends and Opportunities
- Biosimilar Development: While complex, biosimilar versions could erode pricing by 2030.
- Market Expansion: Entry into emerging markets could lead to localized price reductions but increase global volume.
- Combination Products: Potential combination with other heart failure agents may optimize therapeutic regimens and influence pricing.
Conclusion
Entresto remains a high-value therapy within the HFrEF market, supported by robust clinical data, guideline support, and patent protections. Its current pricing reflects its therapeutic advantages but faces pressure from evolving reimbursement strategies and impending patent cliffs. Stakeholders should anticipate pricing stabilization in the near term, with significant reductions post-patent expiration, especially if biosimilars are introduced. A strategic focus on expanding indications and geographic reach offers avenues for sustained revenue growth.
Key Takeaways
- Market Leadership: Entresto is established as the standard of care for HFrEF, driving consistent revenue streams.
- Pricing Stability: Current pricing remains high but is subject to compression amid emerging biosimilars and competitive therapies.
- Patent Fortification: Patent protection until ~2030 supports pricing power; expiration invites generic entry.
- Global Expansion: Increasing access in emerging markets can augment sales volumes, offsetting domestic price pressures.
- Future Outlook: Price declines are inevitable post-patent expiration; innovative expansion may prolong premium valuation.
FAQs
1. When is Entresto expected to face generic competition?
Patent exclusivity is expected to last until approximately 2030, after which biosimilar or generic versions could enter the market, driving prices downward.
2. How does Entresto's pricing compare with traditional heart failure therapies?
Entresto's monthly cost (~USD 575–600) is higher than many ACE inhibitors or ARBs, reflecting its advanced mechanism and clinical superiority; however, this is often offset by reduced hospitalization costs.
3. What factors influence future price projections for Entresto?
Patent expiration, regulatory approvals, market competition, biosimilar development, and reimbursement policies primarily drive future pricing trends.
4. Are there emerging indications that could impact Entresto's market value?
Yes, clinical trials investigating its role in HFpEF and hypertension could expand its eligible patient population, supporting sales growth before patent expiry.
5. How are payers affecting Entresto's market?
Insurance coverage, formulary placement, and out-of-pocket costs significantly influence patient access and physician prescribing behaviors, impacting market share and pricing strategies.
References
[1] American Heart Association. Heart failure facts and statistics. 2022.
[2] Markets and Markets. Heart Failure Therapeutics Market Forecast until 2026. 2021.
[3] IQVIA. Prescription Data for Heart Failure Medications. 2022.
[4] Red Book Online. Pharmaceutical Pricing Data. 2023.
