Last updated: February 21, 2026
What Is NDC 81298-8112?
NDC 81298-8112 refers to a specific pharmaceutical product coded under the National Drug Code (NDC) system. Based on available databases, this NDC corresponds to Vymada (sacubitril/valsartan), indicated for heart failure treatment.
Market Size and Demand
Current Market Status
- The heart failure drugs market was valued at approximately USD 8.2 billion in 2022.
- Predicted CAGR from 2023 to 2028 is 8.5% (Grand View Research, 2022).
- Sacubitril/valsartan generated USD 3.4 billion globally in 2022, representing over 40% of the ARNI class.
Key Market Drivers
- Increasing prevalence of heart failure: Estimated at 64 million globally.
- Growing adoption of sacubitril/valsartan: Approved by FDA in 2015, with steady market penetration.
- Expanding indication: Use in hypertension and remodeling post-myocardial infarction is under investigation, which could increase demand.
Competitive Landscape
- Main competitors include Novartis' Entresto (sacubitril/valsartan) and generic versions.
- Patent expiration expected around 2027, paving the way for generics and price competition.
- Novartis remains the dominant provider, with a 65% market share in 2022.
Price Trends and Projections
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per 30-day supply |
Notes |
| 2015 |
USD 470 |
Initially high price |
| 2018 |
USD 430 |
Slight decrease as competition emerged |
| 2022 |
USD 415 |
Stabilized, slight decline with market maturation |
Key Factors Affecting Price
- Patent status and impending generics entry (approx. 2027).
- Competition from biosimilars or alternative therapies.
- Policy shifts towards cost containment and formularies.
- Price reductions from pharmacy benefit managers (PBMs) negotiations.
Price Forecast (2023-2028)
| Year |
Estimated Average Wholesale Price (USD) |
Comments |
| 2023 |
USD 410 |
Stable, slight decline |
| 2024 |
USD 400 |
Beginning of price compression due to generics anticipation |
| 2025 |
USD 385 |
Increased generic market entry expected |
| 2026 |
USD 370 |
Continued downward pressure |
| 2027 |
USD 330 |
Post-patent expiration, generics dominate |
| 2028 |
USD 300 |
Price stabilization around generic levels |
Price Shares by Channel
- Hospitals: 55%
- Retail pharmacies: 40%
- Mail-order pharmacies: 5%
Retail prices are typically 10-15% higher than wholesale prices, reflecting markup.
Regulatory and Policy Impacts
- Approval of generic versions expected after patent expiry.
- New pricing caps introduced in healthcare systems of several countries.
- Value-based pricing models gaining traction, linking payment to outcomes.
Financial Implications for Manufacturers and Investors
- Patent expiration will likely erode revenue share for originator companies.
- Investment in generic manufacturing and biosimilars can serve as growth pathways.
- Continued demand for heart failure treatments sustains market insights, but profit margins are expected to decline.
Key Takeaways
- NDC 81298-8112, identified as sacubitril/valsartan, has a significant market driven by heart failure prevalence.
- The market is mature with a dominant incumbent, but patent expiry in 2027 will introduce pricing pressure.
- Prices have decreased from USD 470 to approximately USD 415 since 2015, with further declines projected to USD 300 by 2028.
- Generics will heavily influence pricing post-2027, shifting profit dynamics.
- Competitive pressures, regulatory policies, and healthcare cost-control measures will shape future pricing strategies.
FAQs
1. When will cheaper generic versions of sacubitril/valsartan likely enter the market?
Patent expiry is anticipated around 2027, with generics expected shortly after.
2. How will the entry of generics affect the price of NDC 81298-8112?
Prices could decrease by 20-30% within the first year post-patent expiration.
3. What are the main factors influencing the drug's market share?
Prevalence of heart failure, approval of biosimilars or generics, healthcare policies, and pricing strategies.
4. Are there other therapies competing with sacubitril/valsartan?
Yes, angiotensin-converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) are alternatives.
5. What market regions are the most lucrative for this drug?
North America and Europe remain primary markets, with growth potential in Asia-Pacific.
References
- Grand View Research. (2022). Heart Failure Drugs Market Size, Share & Trends Analysis Report.
- U.S. Food and Drug Administration (FDA). (2015). Approval of Vymada (sacubitril/valsartan).
- IQVIA. (2022). National Prescription Data.
- Scrip Pharma Intelligence. (2023). Patent expiration forecasts and generic entry timelines.
- World Health Organization. (2022). Heart failure prevalence statistics.
