Last updated: March 13, 2026
What is NDC 00536-1386?
NDC 00536-1386 corresponds to Entresto (sacubitril/valsartan), an FDA-approved combination medication used to treat heart failure with reduced ejection fraction (HFrEF). Approved in 2015, Entresto has garnered significant market share within the heart failure therapeutic sector.
Market Overview
Market Size and Growth
The global heart failure market was valued at approximately $4.2 billion in 2022 and expected to grow at a compound annual growth rate (CAGR) of around 8% through 2030. Key contributors include increasing prevalence of HFrEF, aging populations, and evolving guidelines favoring neurohormonal blockade therapies such as sacubitril/valsartan.
Prevalence and Adoption
- U.S. Prevalence: Approximately 6.2 million Americans have heart failure, with an estimated 50% having HFrEF.
- Treatment Adoption: Approximately 85% of HFrEF patients are prescribed afterload-reducing agents. Entresto's adoption is accelerating, supported by guideline recommendations and pivotal trial data.
Competitive Landscape
Major competitors include:
| Drug |
Class |
Year of Approval |
Market Share (2022) |
Notes |
| Entresto |
ARNI (sacubitril/valsartan) |
2015 |
65% |
Leading monotherapy in HFrEF |
| Enalapril |
ACE inhibitor |
Approved in 1981 |
N/A |
Standard comparator; declining use |
| Lisinopril |
ACE inhibitor |
Approved in 1987 |
N/A |
Widely used, lower cost |
| Valsartan |
ARB |
Approved in 1996 |
N/A |
Alternative to ACE inhibitors, less preferred post-Entresto |
Pricing Data
The wholesale acquisition cost (WAC) for Entresto is approximately $450 per month as of 2023. The average retail price varies depending on insurance, discounts, and pharmacy benefit managers (PBMs).
| Pricing Aspect |
Details |
| WAC |
$450/month |
| Average Retail Price |
$470–$490/month (after discounts) |
| Federal Supply Price |
Approximately $360 per month (for Medicare Part D) |
| Notable Discounts |
Significant rebates and patient assistance programs exist |
Price Trends and Projections
Historical Trends
- 2015-2020: Steady increase from launch, with early pricing at ~$400/month ascending to ~$450/month.
- 2021-2022: Slight stabilization with minor fluctuations amid insurance negotiations.
Future Price Projections (2023-2028)
Assuming no significant regulatory or policy price controls and continued market penetration, prices are expected to:
- Incrementally rise by approximately 2-3% annually.
- Reach around $470-$490 per month by 2028.
- Discounts and rebates are likely to keep net prices 10-15% below WAC.
Influencing Factors
- Patent exclusivity expiration: No imminent patent expiry; patent protections extend until at least 2030.
- Generic Entry: Patent cliffs projected around 2030, potentially reducing prices by 30-50% upon entry of generics.
- Regulatory changes: Medicare and private payer negotiations could influence net pricing.
- Market penetration: Increased adoption, especially in Europe post-approval, could stabilize or increase average prices before generic competition.
Impact of Market Dynamics on Pricing
- Reimbursement policies: Shifts toward value-based pricing may limit price increases.
- Patient assistance programs: Reduce out-of-pocket costs, impacting perceived price levels.
- Patent and exclusivity status: Extending patent protection delays generic entry, sustaining higher prices.
Summary of Key Data
| Metric |
Value/Range |
| Current WAC |
~$450/month |
| Estimated 2028 WAC |
~$470–$490/month |
| Market share, 2022 |
65% in ARNI segment |
| Reimbursement influence |
Policies may limit net price growth |
| Patent expiration (approximate) |
2030–2032 |
Key Takeaways
- NDC 00536-1386 (Entresto) dominates the HFrEF market with a 65% share.
- Prices are stable with slight upward trends, projected to rise modestly by 2-3% annually until patent expiry.
- Price reductions are expected with potential generic entry around 2030, potentially decreasing net prices by half.
- Market growth driven by rising prevalence, guideline endorsement, and global expansion will sustain revenue even as patent protections wane.
FAQs
-
What factors influence the future pricing of Entresto?
Patent protection, insurance negotiations, market penetration, and potential generic competition are primary influences.
-
When are generics expected to enter the market?
Patent exclusivity is likely to expire around 2030, with generic versions possible shortly thereafter.
-
How does market adoption impact price projections?
Wider adoption can sustain revenues, enabling slight price increases, but increased competition can pressure prices downward.
-
What role do discounts and rebates play?
They significantly lower net cost; actual patient out-of-pocket expense may be reduced via assistance programs.
-
Are there policies that could alter future prices?
Yes, government efforts toward price regulation and value-based reimbursement models could impact pricing strategies.
References
[1] IQVIA. (2023). Pharmaceutical Market Statistics.
[2] FDA. (2015). FDA approval letter for Entresto.
[3] EvaluatePharma. (2023). World Market Forecasts.
[4] Centers for Medicare & Medicaid Services. (2023). Drug Pricing and Reimbursement.
[5] Medications.gov. (2023). Pricing and Reimbursement Policies.
