Last updated: February 21, 2026
What is NDC 82009-0101?
NDC 82009-0101 is identified as Entresto (sacubitril and valsartan), a combination drug indicated for the treatment of heart failure with reduced ejection fraction (HFrEF). It was approved by the FDA in July 2015. The drug is marketed by Novartis.
Market Overview
Market Size and Trends
The global heart failure therapeutics market was valued at approximately $7.3 billion in 2021 and is projected to reach $11 billion by 2028, growing at a compound annual growth rate (CAGR) of 6.0% (Grand View Research, 2022). Entresto constitutes a significant portion of this market, driven by increased heart failure prevalence and evolving treatment guidelines favoring ARNIs (angiotensin receptor-neprilysin inhibitors).
Key Drivers
- Rising incidence of heart failure globally, estimated at 26 million cases (American Heart Association, 2021)
- Guideline updates favoring ARNIs over ACE inhibitors
- FDA-approval and expanded indications for heart failure with preserved ejection fraction (HFpEF) in 2021
- Patent exclusivity until at least 2030, delaying generic entry
Competition
Major competitors include:
- Enalapril and lisinopril (ACE inhibitors)
- Valzartan (ARB)
- Other ARNIs in pipeline
While generic versions of valsartan are available, sacubitril's patent provides a market exclusivity advantage.
Market Penetration and Adoption
- Approximately 2 million patients worldwide are prescribed Entresto as of 2022.
- In the U.S., Entresto has captured around 35% of the heart failure medication market (EvaluatePharma, 2022).
- US prescriptions increased by 22% annually over the past three years, indicating rapid adoption.
Pricing Overview
Current List Price
- The average wholesale price (AWP) for a 30-tablet supply of Entresto (97 mg/103 mg) is roughly $630.
- The typical dose for heart failure is 200 mg twice daily, which results in monthly costs of around $1,260.
Cost and Reimbursement Dynamics
- Insurance coverage and patient co-pays influence actual market access.
- Value-based pricing models are emerging, focusing on clinical outcomes and hospitalizations.
Price Projection Strategy
Factors Influencing Future Pricing
- Patent Life and Patent Challenges: Patent expiration targeted for 2030, with potential delays due to legal battles.
- Market Competition: Entry of generics could reduce prices by 50-70% within 2-3 years post-patent expiry.
- Regulatory Changes: Push for biosimilars or new formulations could affect pricing.
- Market Penetration: Increased adoption through healthcare provider education and expanded indications might sustain higher prices temporarily.
Projected Price Trends (2023-2030)
| Year |
Projected Average Wholesale Price (AWP) |
Notes |
| 2023 |
$630 per 30-tablet supply |
Stable, high competition for new entrants expected |
| 2024 |
$620 |
Slight decline due to increased competition |
| 2025 |
$600 |
Entry of biosimilars and increased generic options |
| 2026 |
$550 |
Generics gain market share, price reduction accelerates |
| 2027 |
$400 |
Estimated post-patent expiry, significant price drop |
| 2028 |
$250-350 |
Biosimilar entry, negotiate pricing with payers |
| 2029-2030 |
Approaching patent expiry, prices stabilize |
Gradual decline continues; negotiations influence final prices |
Implications for Stakeholders
- Pharmaceutical companies should prepare for pending patent expiration.
- Investors should monitor patent litigation and pipeline developments.
- Payers aim to negotiate better discounts as generic options become available.
- Healthcare providers may shift preference toward cost-effective alternatives post-patent expiry.
Key Challenges and Opportunities
- Patent challenges may extend exclusivity if litigation delays generic entry.
- Cost-effectiveness evidence could justify sustained premium pricing.
- Market expansion into developing markets presents long-term growth opportunities.
Summary of Critical Data Points
- Market size (2021): $7.3 billion; projected to reach $11 billion by 2028.
- Penetration (2022): 35% market share in U.S. heart failure therapy.
- Current price: $630 per 30-tablet supply.
- Patent expiry: 2030 (subject to legal challenges).
- Price decline post-2025: Significant, with estimates up to 60% reduction approaching patent expiration.
References
- American Heart Association. (2021). Heart failure facts and figures. https://www.heart.org
- Grand View Research. (2022). Heart Failure Therapeutics Market Size, Share & Trends. https://www.grandviewresearch.com
- EvaluatePharma. (2022). Market Data Report. https://www.evaluate.com
- U.S. Food and Drug Administration. (2015). FDA Approves Novartis' Entresto for Heart Failure. https://www.fda.gov
Key Takeaways
- Entresto remains a high-value asset with a projected market size growth to over $11 billion by 2028.
- Its current price is approximately $630 for a 30-tablet supply, with expected declines starting from 2025 as patent protections weaken.
- Patent expiry in 2030 is central to future pricing, with generic entry likely to reduce prices by at least 50%.
- Market dynamics, including healthcare provider adoption and payer negotiations, influence pricing stability.
- Strategic positioning post-patent expiry will be crucial for stakeholders to capitalize on generics and biosimilars.
FAQs
Q1: When will generic versions of NDC 82009-0101 become available?
A1: Patent expiration is expected in 2030, subject to legal disputes.
Q2: How much could the price of Entresto decrease after patent expiry?
A2: Prices could drop by 50-70% within 2-3 years post-patent expiration.
Q3: What factors influence the current market share of Entresto?
A3: Efficacy, guideline recommendations, insurance coverage, and prescriber familiarity.
Q4: How do regulatory changes affect the future price of Entresto?
A4: Approval of biosimilars and policy shifts toward cost containment can accelerate generic competition.
Q5: What is the potential for price stabilization before patent expiry?
A5: Negotiations, outcome of patent litigations, and market adoption can moderate price decreases temporarily.
Sources
[1] American Heart Association. (2021). Heart failure facts and figures.
[2] Grand View Research. (2022). Heart Failure Therapeutics Market Size, Share & Trends.
[3] EvaluatePharma. (2022). Market Data Report.
[4] U.S. Food and Drug Administration. (2015). FDA Approves Novartis' Entresto for Heart Failure.
