Last updated: March 5, 2026
What is NDC 50268-0774?
NDC 50268-0774 corresponds to Entresto (sacubitril/valsartan), an angiotensin receptor-neprilysin inhibitor (ARNI) used for treating heart failure with reduced ejection fraction (HFrEF). Marketed by Novartis, Entresto received FDA approval in July 2015 and pushed into the market as a successor to ACE inhibitors and ARBs for symptomatic heart failure management.
Current Market Landscape
Market Penetration and Usage
- 2018-2022 Growth: The market for heart failure drugs grew at a compound annual growth rate (CAGR) of approximately 6% in the U.S.
- Prescription Trends: Entresto’s market share in HFrEF treatments increased from 45% in 2018 to over 70% in 2022 among prescribed therapies.
- Patient Population: Estimated 6 million adults in the U.S. diagnosed with heart failure, of which approximately 50% have HFrEF.
- Revenue (2022): Estimated at USD 2.5 billion globally, with USD 2 billion from the U.S. market (IQVIA, 2022).
Competitive Landscape
- Key Competitors: Enalapril, lisinopril, carvedilol, and other standard heart failure medications.
- Pipeline Drugs: Other ARNIs and novel heart failure treatments under development include Omecamtiv mecarbil and SGLT2 inhibitors like dapagliflozin and empagliflozin.
- Market Share Drivers: Clinical trial data showing superiority in reducing hospitalization and mortality rates.
Regulatory and Reimbursement Environment
- FDA Approvals: The drug is approved for patients with NYHA class II-IV HFrEF.
- Insurance Coverage: Widely covered under Medicare Part D, with rebates encouraging prescriptions.
- Pricing Policies: Subject to negotiations with payers; price controls in some markets threaten margins.
Price Trends and Projections
Historical Pricing
| Year |
Wholesale Acquisition Cost (WAC) per 30-day supply |
Notes |
| 2015 |
USD 490 |
Launch price |
| 2018 |
USD 530 |
Price increase over initial launch |
| 2022 |
USD 590 |
Continued incremental adjustment |
Future Price Projections (2023-2027)
- Inflation-adjusted prognosis: Prices may stabilize or decline slightly due to market pressures and rebate negotiations.
- Integrated price trend: Expect a compound annual decrease of approximately 1-3% in net realized price due to payer discounts and biosimilar entry scenarios.
- Rebate impact: Estimated rebates of 20-30% could significantly lower the net price.
Market Volume Projections
- 2023-2027 Volume CAGR: Estimated at 4% driven by increasing adoption and expanding indications.
- Total Market Value: Projected to reach USD 2.8-3.2 billion globally by 2027, assuming continued market penetration.
Key Factors Affecting Price and Market Share
- Patent Expirations: No imminent patent losses; exclusivity until at least 2030.
- Biosimilar Entry: No biosimilar competitors currently; entry unlikely in the next 3-5 years.
- Clinical Evidence: Ongoing studies could expand indications, increasing volume but potentially exerting downward pressure on prices.
Risks and Opportunities
| Risk |
Impact |
| Price erosion due to rebates and negotiations |
Lower net revenue per prescription. |
| Aggressive competition from pipeline drugs |
Market share could decline if newer treatments show superior efficacy or safety. |
| Shifts in heart failure treatment guidelines |
May favor or disfavor ARNI class depending on emerging data. |
| Opportunity |
Impact |
| New indications |
Expanding uses for heart failure with preserved ejection fraction (HFpEF). |
| Increased adoption in emerging markets |
Growing global markets can drive higher volumes. |
Summary
Entresto (NDC 50268-0774) is the dominant ARNI in the heart failure market, with steady growth driven by clinical efficacy and formulary acceptance. Pricing has increased modestly since launch, with future price adjustments likely to be tempered by payer pressures and market dynamics. Market expansion hinges on new indications, clinical trial results, and competitive developments.
Key Takeaways
- Market value for Entresto is approximately USD 2.5 billion globally as of 2022.
- Price per 30-day supply stood around USD 590, with projections indicating slight decreases owing to discounts.
- Adoption continues to grow at a CAGR of 4%, with market expansion driven by increased diagnosis and guideline updates.
- Competitive landscape remains stable; biosimilars are unlikely in the near term.
- Pricing and market share may face downward pressures from payers, but clinical superiority supports sustained revenue growth.
FAQs
1. What factors could cause Entresto’s price to decline?
Rebate negotiations, payer discounts, and biosimilar entry could lower effective prices.
2. How does clinical trial data influence Entresto’s market share?
Positive data confirming superior efficacy sustains and increases prescription volumes; negative or neutral results could limit growth.
3. When might biosimilars enter the market?
Biosimilars for sacubitril/valsartan are unlikely before 2026 due to patent protections and regulatory hurdles.
4. Are there upcoming regulatory decisions that could impact Entresto?
Potential approval for additional indications, such as HFpEF, could expand its market.
5. How does the U.S. reimbursement landscape affect Entresto prices?
Reimbursement policies and formulary placement significantly influence net prices and adoption rates.
References
- IQVIA. (2022). Market data for heart failure drugs.
- FDA. (2015). Entresto (sacubitril/valsartan) approval announcement.
- Novartis. (2022). Annual report and pipeline summary.
