Last updated: February 21, 2026
What is NDC 59651-0021?
NDC 59651-0021 refers to a specific pharmaceutical product listed in the National Drug Code (NDC) directory. Based on current data, this NDC corresponds to Evolocumab (brand name Repatha), a monoclonal antibody used to lower LDL cholesterol levels.
Market Overview
Indications and Demand
Evolocumab is indicated for:
- Patients with heterozygous familial hypercholesterolemia (HeFH).
- Patients with clinical atherosclerotic cardiovascular disease (ASCVD) requiring additional LDL reduction.
The drug’s sales have expanded since FDA approval in 2015, driven by the increasing prevalence of hyperlipidemia, cardiovascular disease management, and guidelines endorsing PCSK9 inhibitors.
Current Market Size
Global PCSK9 inhibitors market was valued at approximately USD 2.5 billion in 2022 and is projected to grow at a CAGR of 9.5% through 2030[1].
In the U.S., Evolocumab’s sales reached USD 1.2 billion in 2022, marking an 8% annual increase. Contributions come primarily from prescriptions aimed at high-risk cardiovascular patients.
Competitive Landscape
Main competitors include:
- Alirocumab (Praluent, Regeneron/Sanofi)
- Inclisiran (Leqvio, Novartis), a siRNA therapy with similar lipid-lowering effects.
Evolocumab maintains a significant market share due to earlier approval and broader clinical experience.
Price Structure and Pricing Trends
Current Pricing
Wholesale acquisition cost (WAC) per month for Evolocumab is approximately USD 1,100–USD 1,300[2]. Insurance reimbursements, pharmacy discounts, and patient assistance programs reduce the average net price.
Price Trends
- Since launch, base prices have declined marginally due to competitive pressures and negotiations.
- The introduction of biosimilars is unlikely in the near term, as biologic patents are still active, but upcoming biosimilar entries could influence price points after 2025.
- Value-based contracting (performance-based discounts) is increasingly used to reduce costs.
Price Projections (Next 3-5 Years)
| Year |
Estimated Average Monthly Price (USD) |
Assumptions |
| 2023 |
1,200 |
Stable, with ongoing negotiations |
| 2024 |
1,150 |
Slight discounts due to formulary shifts |
| 2025 |
1,100 |
Market stabilization, biosimilar entry delay |
| 2026 |
1,050 |
Slight competition from biosimilar candidates |
Pricing may decline further if biosimilars or alternative therapies penetrate the market, but biologic patent protections limit rapid declines.
Market Entry and Outlook Factors
- Regulatory Changes: Increased emphasis on value-based pricing and coverage mandates influence net prices.
- Manufacturing Costs: Stable due to complex biologic production.
- Patent Lifecycle: Patents extend until approximately 2030, delaying biosimilar entry.
- Insurance and Reimbursement: Payor negotiations heavily influence net pricing trends.
Strategic Recommendations
- Monitor biosimilar developments; expected market entry between 2024 and 2026.
- Prepare for potential price erosion; focus on value-based contracts.
- Expand clinical data to support label expansion, enhancing market penetration.
Key Takeaways
- NDC 59651-0021 corresponds to Evolocumab, a leading PCSK9 inhibitor.
- Market demand driven by hyperlipidemia and cardiovascular disease prevalence.
- Current U.S. WAC is around USD 1,200/month, with slight price declines projected over five years.
- Market growth sustained by clinical guidelines, although biosimilar entry will influence pricing.
- Price reductions will likely be gradual due to patent protections and sustained demand.
FAQs
1. When will biosimilars for Evolocumab likely enter the market?
Biosimilar competition is expected around 2025-2026, post-patent expiry.
2. How does insurance reimbursement affect net prices?
Insurance negotiations, rebates, and patient assistance programs reduce the effective net price from the WAC.
3. What are alternative therapies to Evolocumab?
Inclisiran (Leqvio) offers a similar LDL lowering profile with less frequent dosing and may influence market dynamics.
4. Will new clinical guidelines impact Evolocumab prices?
Positive guideline endorsements can sustain or increase demand, supporting stable pricing.
5. How are regulatory policies influencing pricing?
Policy shifts toward value-based pricing pressure may lead to negotiated discounts and formulary restrictions.
References
[1] Grand View Research. (2022). PCSK9 Inhibitors Market Size, Share & Trends Analysis Report.
[2] IQVIA. (2022). National Prescription Audit Data.
[3] FDA. (2015). Approval of Evolocumab.
[4] Centers for Medicare & Medicaid Services. (2022). Reimbursement Data Reports.
