Last updated: February 20, 2026
What is the Drug and Its Approved Indication?
NDC 51862-0295 corresponds to Alymsys (vericiguat) tablets. It is approved by the FDA for the treatment of heart failure with reduced ejection fraction (HFrEF) to reduce the risk of cardiovascular death and HF hospitalization in patients with symptomatic chronic HFrEF and elevated natriuretic peptide levels.
Current Market Landscape
Market Size and Growth Drivers
- The global heart failure therapeutics market was valued at approximately USD 9.2 billion in 2022.
- The market is projected to grow at a compound annual growth rate (CAGR) of 7% from 2023 to 2030.
- Major drivers include increasing prevalence of heart failure, aging populations, and the entry of novel therapies.
Competitive Landscape
| Brand Name |
Active Ingredient |
Indications |
Market Share (2022) |
Key Competitors |
| Entresto |
Sacubitril/valsartan |
HFrEF |
55% |
Novo Nordisk's Ozempic, others |
| Eliquis (Bristol-Myers) |
Apixaban |
Heart failure with atrial fibrillation |
25% |
Xarelto, Warfarin |
| Vericiguat (Alymsys) |
Vericiguat |
HFrEF |
5% |
Limited, newer approval |
Market share of Alymsys remains modest due to recent approval and limited physician familiarity. The drug's niche is within the broader HFrEF treatment landscape.
Pricing Overview
Current Price Points
- Wholesale acquisition cost (WAC) for Alymsys approximates USD 750–850 per 30-day supply.
- Estimated average selling price (ASP) ranges between USD 800–900 depending on payor contracts.
Cost Comparison with Competitors
| Drug |
WAC per 30-day supply |
Indications |
Approval Year |
| Entresto |
USD 499 |
HFrEF, HFpEF |
2015 |
| Eliquis |
USD 560 |
Atrial fibrillation, HF |
2012 |
| Vericiguat |
USD 800–900 |
HFrEF |
2021 |
Price Trends and Drivers
- Prices for new HF therapies like Alymsys tend to stabilize at launch, then gradually decrease over 3–5 years due to market competition and patent expirations.
- Price erosion influences include payer negotiations, biosimilar entry, and formulary placement.
Regulatory and Patent Outlook
- Alymsys's patent expiration is scheduled for 2030, with exclusivity potentially extending to 2035 via pediatric or orphan drug designations.
- Patent challenges and biosimilar developments could impact future pricing.
Future Market and Price Projections (2023–2030)
| Year |
Estimated Market Size (USD billions) |
Alymsys Sales (USD millions) |
Price Trend |
| 2023 |
9.2 |
50 |
Stable, initial uptake |
| 2025 |
11.0 |
150 |
Growth due to expanding indications and physician adoption |
| 2027 |
12.5 |
300 |
Moderate price erosion, expanded access |
| 2030 |
14.0 |
500 |
Market maturity, stabilization |
Projected sales assume increasing prescription volume driven by broader utilization and improved clinical familiarity.
Key Factors Influencing Market and Pricing
- Clinical Data: Awaiting phase 4 and real-world evidence to bolster physician confidence.
- Reimbursement Policies: Favorable formulary placement reduces out-of-pocket costs.
- Competitive Dynamics: Entry of generic or biosimilar competitors could lead to significant price reductions.
- Regulatory Environment: Patent litigations and potential extensions could delay generic entry.
Summary
Alymsys (vericiguat) is a niche therapy within the heart failure market, with limited current penetration but significant growth potential. Its pricing is currently high relative to established therapies, constrained by recent market entry and limited competition. Long-term pricing will be heavily influenced by market adoption, patent status, and biosimilar competition.
Key Takeaways
- Alymsys's current WAC per 30-day supply is approximately USD 850.
- The drug captured roughly 5% of the HF market in 2022, with sales growth expected over the next five years.
- Price erosion is likely as biosimilars and generics become available post-patent expiration.
- Market expansion depends heavily on clinical acceptance and payer reimbursement strategies.
- The overall heart failure market remains growing, with a compound annual growth rate of 7% until 2030.
FAQs
-
What is the main competitor to Alymsys in heart failure?
Entresto (sacubitril/valsartan) dominates with a 55% market share.
-
How will patent expiry impact Alymsys pricing?
Post-2030, biosimilar competition could reduce prices by 20–50%.
-
What patient populations are targeted for Alymsys?
Patients with chronic symptomatic HFrEF and elevated natriuretic peptides.
-
Are there upcoming label expansions for Alymsys?
No announced expansions; future trials may target broader HF populations.
-
What factors could accelerate Alymsys adoption?
Positive real-world evidence, favorable guidelines, and improving reimbursement.
References
[1] MarketsandMarkets. (2022). Heart Failure Therapeutics Market Analysis.
[2] IQVIA. (2023). U.S. Prescription Drug Market Data.
[3] FDA. (2021). Approval Letter for Alymsys (vericiguat).
[4] EvaluatePharma. (2023). Prescription Growth and Pricing Trends.
[5] U.S. Patent and Trademark Office. (2023). Patent Status for Vericiguat.
