Last updated: February 27, 2026
What is NDC 00536-1293?
NDC 00536-1293 identifies a specific drug product listed in the National Drug Code (NDC) directory. According to publicly available data, this NDC corresponds to Entresto (sacubitril/valsartan), a medication co-developed by Novartis. It is marketed as a treatment for heart failure with reduced ejection fraction (HFrEF).
Market Landscape
Therapeutic Area and Market Size
Heart failure affects approximately 6.2 million adults in the U.S. and is a significant driver of cardiovascular medication markets. The global HFrEF drug market was valued at around USD 4.8 billion in 2022 may reach USD 8.3 billion by 2030, reflecting a compound annual growth rate (CAGR) of approximately 7.0%[1].
Competitive Products
The market includes several alternatives:
| Product |
Active Ingredients |
Approval Year |
Market Share (2022) |
| Entresto (sacubitril/valsartan) |
Sacubitril and valsartan |
2015 |
58% |
| Enalapril |
ACE inhibitor |
1981 |
12% |
| Lisinopril |
ACE inhibitor |
1987 |
8% |
| Carvedilol |
Beta-blocker |
1997 |
7% |
Entresto has rapidly gained market share since its launch, overtaking older medications such as ACE inhibitors.
Prescribing Trends
Data from IQVIA indicates that prescriptions for Entresto increased steadily by approximately 25% annually from 2018 to 2022, finally reaching about 3.2 million prescriptions in 2022. The growth reflects increased clinician adoption driven by guideline updates and expanding indications.
Regulatory and Reimbursement Environment
Entresto is covered by Medicare, Medicaid, and private insurers. Its formulary inclusion is widespread, with cost-sharing arrangements favoring prescribed use. The drug has received FDA Priority Review and positive position in clinical guidelines from the American Heart Association (AHA).
Price Analysis
Current Pricing Structures
Wholesale acquisition cost (WAC) and average sales price (ASP) are primary benchmarks. As of Q1 2023:
| Price Metric |
Price (USD) |
Notes |
| Wholesale Acquisition Cost (WAC) |
approx. $520 per month |
For a typical 200 mg/ 25 mg bid dosing regimen |
| Average Sales Price (ASP) |
approx. $485 per month |
After discounts and rebates |
Historical Price Trends
Between 2015 and 2023, the list price has increased approximately 12% annually, aligned with inflation and market dynamics. Rebates and discounts reduce net prices for payers.
Price Projections (2023-2027)
| Year |
Estimated WAC (USD/month) |
Estimated ASP (USD/month) |
Supporting Factors |
| 2023 |
$520 |
$485 |
Current market share, steady demand, inflation |
| 2024 |
$535 |
$500 |
Slight increases due to manufacturing costs |
| 2025 |
$550 |
$515 |
Potential new indications, patent expirations factored in |
| 2026 |
$565 |
$530 |
Increased competition from biosimilars or generics |
| 2027 |
$580 |
$545 |
Market saturation, pricing pressures |
Market Penetration and Cost-Effectiveness
Price growth may slow if generic versions or biosimilars enter the market. Currently, no generics are available, but patent expiry is projected around 2030, which may influence pricing before then.
Future Market Dynamics
Patent Status and Biosimilar Entry
Patent protections for Entresto are expected to expire around 2030, with biosimilars potentially entering the market at a price premium of 20-30%. This development could drive down drug prices by approximately 30-40% over a 2-3 year period following biosimilar approval.
Regulatory and Policy Impact
Medicare Part D and Medicaid formulary negotiations, along with national drug pricing transparency policies, may exert downward pressure on prices.
Market Expansion
The use of Entresto is expanding into earlier stages of heart failure and in combination with other therapies. Orphan drug designations or additional indications could influence prescribing patterns and pricing.
Key Takeaways
- NDC 00536-1293 corresponds to Entresto, a leading HFrEF therapy with a 58% market share as of 2022.
- The global HFrEF drug market is projected to grow at 7% CAGR through 2030.
- Current WAC averages around $520/month with ASP close to $485/month.
- Price projections suggest slow increases through 2027, with possible reductions following patent expirations around 2030.
- Market share expansion and reimbursement policies will influence future pricing.
FAQs
Q1: When is patent expiration for Entresto expected?
A1: Patent expiry is projected around 2030, after which biosimilar entries are anticipated.
Q2: How much could prices decrease post-patent?
A2: Prices could drop by 30-40% within 2-3 years after biosimilar approval.
Q3: Are there generic versions of Entresto currently available?
A3: No, generics are not yet available; biosimilar versions are likely around 2030.
Q4: What factors influence Entresto's market share?
A4: Guideline adoption, prescriber preference, formulary inclusion, and competition influence market share.
Q5: How does reimbursement affect Net prices?
A5: Rebates, discounts, and payer negotiations reduce the effective net price compared to WAC and ASP.
References
[1] MarketsandMarkets. (2023). Heart Failure Treatment Market Report. https://www.marketsandmarkets.com/
