Last updated: July 30, 2025
Introduction
The drug identified by the National Drug Code (NDC) 00228-1410 is Entresto (sacubitril/valsartan), developed and marketed by Novartis Pharmaceuticals. Entresto is primarily indicated for heart failure with reduced ejection fraction (HFrEF). As a pivotal agent in cardiovascular therapy, its market dynamics are influenced by a combination of clinical efficacy, regulatory factors, patent status, competitive landscape, and healthcare policy changes.
This analysis assesses current market conditions, key stakeholders, competitive forces, and formulary positioning to project future pricing trajectories over the next five years.
Current Market Landscape
Market Size and Demand
Heart failure remains a significant healthcare burden globally, with the American Heart Association estimating over 6 million Americans living with heart failure, and incidence rising with aging populations [1]. Entresto, launched in 2015, quickly established itself as a standard of care following pivotal trials like PARADIGM-HF, which demonstrated superior outcomes compared to ACE inhibitors [2].
The U.S. market for heart failure therapies was valued at approximately $4 billion in 2022, with Entresto capturing roughly 60% of the prescription volume within this segment [3]. The growth rate for this category remains robust due to increased diagnosis rates, expanded acceptance among clinicians, and evolving guidelines.
Regulatory and Patent Status
Entresto’s initial exclusivity period extends until 2027, with patent protections providing a competitive moat. However, biosimilar and generic entrants could emerge post-patent expiry, potentially reducing prices. The patent landscape and legal challenges are critical factors that could alter pricing and market dynamics prior to 2027.
Competitive Landscape
While Entresto remains the frontrunner, generic angiotensin receptor blockers (ARBs) and ACE inhibitors continue to provide more affordable alternatives. Newly approved drugs, such as soluble guanylate cyclase stimulators (e.g., Vericiguat), are emerging competitors, albeit with niche applications.
The market is also seeing increased adoption of combination and comprehensive heart failure management protocols, which could influence demand patterns.
Pricing Trends and Projections
Historical Pricing
Initially launched at a wholesale acquisition cost (WAC) of approximately $470 per month for a standard 24/26 mg dose, Entresto’s price has seen moderate inflation aligned with medical inflation and research & development recoupment costs. The average retail price varies between $460-$500/month, generally higher than other ARBs.
Factors Influencing Price Trajectory
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Patent Expiry and Biosimilar Entry: Anticipated post-2027, which could catalyze price reductions ranging from 20-50%, pending regulatory and market uptake.
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Reimbursement and Formularies: Favorable inclusion in major insurance formularies sustains current pricing levels; however, shifts toward more cost-sensitive plans could pressure discounts.
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Manufacturing and Distribution Costs: Incremental reductions are possible with technological efficiencies in production, potentially easing price inflation.
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Market Expansion: Broadened indications, such as earlier intervention in heart failure or heart failure with preserved ejection fraction (though currently less approved), could increase volume, stabilizing or reducing per-unit prices due to economies of scale.
Projected Price Range (2023–2028)
| Year |
Estimated Wholesale Price (per month) |
Key Factors |
| 2023 |
$470–$490 |
Stable, with minor inflation |
| 2024 |
$470–$490 |
Continued demand; slight inflation |
| 2025 |
$460–$480 |
Anticipated generic threat readiness |
| 2026 |
$450–$470 |
Post-patent expiry preparations; cautious discounts |
| 2027+ |
$350–$460 |
Potential generic entry; volume-driven pricing |
Note: These figures are projections grounded in current market trends and regulatory milestones.
Market Drivers and Impediments
Drivers:
- Growing prevalence of heart failure
- Evidence-based guidelines endorsing Entresto
- Favorable clinical outcomes validated in large trials
- Expanded insurer and formulary inclusion
Impediments:
- Patent expiration risk and biosimilar competition
- Cost-containment pressures from providers and payers
- Perception of high drug prices relative to alternative therapies
- Market saturation and increasing generic availability
- Potential shifts in clinical guidelines emphasizing cost-effective care
Strategic Considerations for Stakeholders
Manufacturers: Focus on optimizing manufacturing efficiency, fostering formulary access, and differentiating through clinical outcomes and patient adherence programs.
Payers: Engage in formulary negotiations, incentivize therapies with proven cost-effectiveness, and monitor biosimilar developments.
Providers: Balance clinical benefit against cost considerations, especially in resource-constrained settings.
Policymakers: Promote transparency in drug pricing and support biosimilar integration for cost containment.
Key Takeaways
- Market growth for Entresto remains robust driven by increasing heart failure prevalence and its position as a leading therapy.
- Price stability is likely in the short term (up to 2024), with modest inflation primarily driven by healthcare cost trends.
- Post-2027, significant price declines are probable as patent protections expire and biosimilars or generics enter the market.
- Stakeholders must monitor regulatory developments, patent timelines, and biosimilar approvals to optimize financial and clinical decision-making.
- Cost-effectiveness evaluations will increasingly influence formulary decisions, impacting future pricing and market share.
FAQs
1. When is the patent for Entresto set to expire?
Patent protections are anticipated to expire around 2027, opening the pathway for biosimilar entries.
2. How does Entresto compare to generic ARBs in cost?
Generic ARBs can cost as low as $20–$50 per month, significantly less than Entresto’s estimated $470–$490 per month, influencing prescribing patterns once patent protections lapse.
3. What are the main factors influencing Entresto’s market share?
Clinical efficacy, guideline endorsements, formulary access, competing therapies, and pricing strategies primarily determine its market penetration.
4. How might biosimilar entry impact Entresto's price?
Biosimilar competitors could reduce prices by 20–50%, depending on market acceptance, regulatory pathways, and payer negotiations.
5. Are there upcoming clinical trials that could influence Entresto’s demand?
Future studies exploring broader indications or combination therapies may expand its use but are not imminent, with current data supporting HFrEF management.
Conclusion
Entresto’s market will experience incremental stabilization in the near term, with significant price adjustments likely following patent expiry in 2027. Stakeholders should proactively monitor regulatory milestones, biosimilar developments, and evolving clinical guidelines to align their strategies with upcoming market transformations.
References
[1] American Heart Association. Heart Failure Facts & Statistics. 2022.
[2] McMurray, J. J. V., et al. (2014). The New England Journal of Medicine, 371(11), 993-1004.
[3] IQVIA, 2022 National Prescription Data.
