Last updated: February 26, 2026
What is NDC 00378-7306?
NDC 00378-7306 corresponds to a specific medication approved by the FDA. Based on the code, it is identified as Entresto (sacubitril/valsartan). Entrastro is used for heart failure with reduced ejection fraction (HFrEF). It was approved by the FDA in July 2015 and has gained significant market penetration within cardiac therapeutics.
Market Size and Adoption
Market Overview
- Indications: Heart failure HFrEF.
- Target Population: 6 million adults in the U.S. diagnosed with heart failure; approximately 50% have reduced ejection fraction.
- Market Penetration: As of 2022, Entresto's prescription volume increased to approximately 2.5 million prescriptions annually.
- Competitive Landscape: Main competitors include ACE inhibitors (e.g., lisinopril), ARBs (e.g., losartan), and other combination therapies.
Market Drivers
- Increasing prevalence of heart failure.
- Growing physician awareness of Entresto’s benefits over traditional ACE inhibitors and ARBs.
- Updated clinical guidelines recommending Sacubitril/Valsartan as initial therapy for HFrEF.
Market Limitations
- Slow adoption in some regions due to cost concerns.
- Prescriber hesitance in switching from established therapies.
- Patent exclusivity until 2026; potential generic entry could reduce prices.
Price Dynamics and Projections
Current Pricing (United States)
- Average Wholesale Price (AWP): Approximately $500 for 30 tablets (97/103 mg dose).
- Estimated Cost to Patients: Retail prices range from $450 to $600 per month without insurance.
- Insurance and PBMs: Reimbursements often reduce patient out-of-pocket costs to roughly $20-$50/month.
Historical Trends
- When first launched in 2015, the average monthly cost was approximately $500.
- Pricing remained relatively stable through 2019.
- In 2020, price reductions occurred as competition intensified and generic versions approached approval.
Future Price projectons (Next 3-5 years)
| Year |
Estimated Price Range (per 30-day supply) |
Comments |
| 2023 |
$400 - $500 |
Monopoly pricing; slight decrease as market saturates. |
| 2024 |
$350 - $450 |
Expected generic entry in late 2024. |
| 2025 |
$250 - $350 |
Post-generic entry, significant price reductions. |
| 2026 |
$150 - $250 |
Fully commoditized with multiple generics available. |
Factors Influencing Price
- Patent expiration: Generic versions anticipated to hit the market in late 2024/early 2025.
- Market competition: Volume-driven discounts will accelerate post-generic entry.
- Regulatory and policy shifts: Price controls or negotiations may influence actual consumer costs.
- Manufacturing costs: Marginal costs will decrease with increased generic manufacturing.
Price Comparison with Competitors
| Drug |
Typical Monthly Price |
Market Position |
Approval Year |
| Entresto (NDC 00378-7306) |
$450 |
Premium option |
2015 |
| Lisinopril (ACE inhibitor) |
$10 |
Cost leader, generic available |
1987 |
| Losartan (ARB) |
$20 |
Moderate cost, generic |
1995 |
Regulatory and Patent Considerations
- Patent Status: Expiration expected in 2026, with patent extensions possibly until 2028.
- Generic Approvals: FDA approved the first generic sacubitril/valsartan in early 2024, with multiple entrants expected.
- Pricing Impact: Generics are projected to reduce the drug’s price by 50% or more.
Investment and Business Implications
- Pharmaceutical Companies: Patent expiry opens pathways for generic manufacturers to capture market share, pressuring prices.
- Pharmacies and PBMs: Will negotiate lower reimbursements as more generics enter.
- Healthcare Payors: Likely to favor generics for cost savings, impacting branded sales.
- R&D Focus: Potential innovation in formulations or combination therapy could extend product lifecycle.
Key Takeaways
- NDC 00378-7306 (Entresto) is a precipitating driver in heart failure treatment post-2015.
- Market size is expanding due to increasing heart failure prevalence and guideline updates.
- Pricing has stabilized but faces downward pressure following patent expiration and generic entry.
- Future prices forecast to decline substantially from current levels, reaching $150–$250 by 2026.
- Market dynamics heavily dependent on patent status, competitive landscape, and healthcare policies.
FAQs
What factors primarily influence Entresto’s price in the U.S.?
The primary factors include patent protection, market competition, insurer negotiations, and regulatory policies.
When are generic versions of sacubitril/valsartan expected to dominate the market?
Generic versions are expected to be widely available post-2024, making a significant impact by 2025.
How does the price of Entresto compare globally?
Prices vary; in Europe, wholesale prices range from $300 to $400 per month, often lower than in the U.S. due to differing healthcare systems.
What is the potential impact of patent expiry on revenue?
Patent expiry typically causes a sharp decline in revenue for the branded product, estimated around 50% in upcoming years as generics enter the market.
Are there ongoing R&D efforts to develop next-generation heart failure drugs?
Yes, multiple pharmaceutical companies are investing in novel compounds and formulations targeting similar pathways but with improved efficacy or reduced costs.
References
[1] Food and Drug Administration. (2015). FDA approves Entresto to treat heart failure.
[2] IQVIA. (2022). Prescription Drug Market Data.
[3] CVS Health. (2022). Medication Price Trends Report.
[4] FDA. (2024). Generic drug approvals list.
[5] Health Policy Institute. (2023). Impact of Patent Expirations on Drug Pricing.
