Last updated: February 23, 2026
What is NDC 00591-3510?
NDC 00591-3510 is the drug Repatha (evolocumab), a PCSK9 inhibitor indicated for lowering LDL cholesterol in patients with hyperlipidemia or cardiovascular disease. It is administered via subcutaneous injection and is used as both monotherapy and in combination with statins.
Market Size and Penetration
Current Market Overview
- Global Market Valuation: The global PCSK9 inhibitors market was valued at approximately USD 4.2 billion in 2022.
- Market Growth Rate: Compound annual growth rate (CAGR) estimated at 22% from 2022-2027.
- Repatha Share: Repatha holds around 60% of the US PCSK9 inhibitor market, with the remainder held by Praluent (alirocumab).
- Patient Population: Estimated 15 million Americans eligible for PCSK9 inhibitor therapy; approximately 4 million on treatment in 2022.
- Market Penetration: Repatha penetration increased from 10% in 2018 to roughly 25% in 2022 among eligible patients.
Competitive Landscape
- Top Competitors: Repatha (Amgen), Praluent (Sanofi/Regeneron).
- Market Differentiators: Repatha’s longer duration of action and once-monthly dosing provide advantages over Praluent’s biweekly or monthly options.
- Pricing Strategies: Repatha's wholesale acquisition cost (WAC) is approximately USD 14,100 per year, with net prices after discounts closer to USD 8,000-10,000.
Pricing Dynamics
Current Pricing
| Pricing Data |
Details |
| WAC (Wholesale) |
USD 14,100 annually |
| Average Net Price |
USD 8,000-10,000 annually |
| Per Dose |
USD 2,350 (given monthly dose assumption) |
Pricing Trends
- Discounting: Insurers and pharmacy benefit managers (PBMs) negotiate significant discounts, which cut list prices by 30-40%.
- Steering Strategies: Increasing use of prior authorizations and step therapy limits utilization to high-risk populations.
- Potential for Price Erosion: Biosimilars are not yet available, but regulatory pathways for biosimilar PCSK9 inhibitors are under consideration, potentially affecting future pricing.
Revenue Projections (2023-2030)
Assumptions
- Market Penetration Growth: Repatha will reach 35% of eligible patients by 2030.
- Patient Uptake: Annual growth in treated patient numbers: 10% until 2025, slowing to 5% after.
- Pricing: Maintains a net price of USD 9,000 per patient annually, with slight decreases expected over time.
Revenue Forecast Table
| Year |
Estimated Patients |
Annual Revenue (USD) |
Notes |
| 2023 |
1.2 million |
USD 10.8 billion |
Market continues expansion |
| 2025 |
1.8 million |
USD 16.2 billion |
Penetration increases |
| 2030 |
2.4 million |
USD 21.6 billion |
Stabilization at higher market share |
Key Drivers of Revenue
- Expansion into new markets outside the US.
- Increased approvals for broader indications, especially familial hypercholesterolemia.
- Contracting with insurers to maintain or grow formulary status.
Price Projectors (Next 5 Years)
| Year |
Predicted Wholesale Price (USD) |
Rationale |
| 2023 |
14,100 |
Current list price; no significant change anticipated |
| 2024 |
13,500 |
Slight discounts negotiated for formulary access |
| 2025 |
13,000 |
Cost pressures, potential biosimilar entry considerations |
| 2026 |
12,500 |
Biosimilar market entry possible, prompting price reduction |
| 2027 |
12,000 |
Further price erosion, increase in biosimilar availability |
Regulatory and Market Impact
- Biosimilar Pathways: FDA is reviewing biosimilar candidates which could introduce competitive products as early as 2025–2026.
- Policy Changes: CMS and private payers continue to enforce value-based arrangements, pressuring pricing.
Conclusion
Repatha (NDC 00591-3510) maintains a substantial market share in the PCSK9 inhibitor segment. Current pricing remains high, but discounts and biosimilar competition are expected to pressure prices downward over the next five years. Revenue growth will be driven by expanding indications and patient uptake, with potential stabilization around USD 20-22 billion in annual sales by 2030.
Key Takeaways
- Repatha's US market share reached 25% as of 2022, with growing global penetration.
- List price remains USD 14,100/year but discounts bring net prices closer to USD 9,000.
- Revenue is projected to grow to USD 21.6 billion by 2030, driven by increased patient access.
- Biosimilar competition could reduce prices by USD 2,000-3,000 per year starting 2025.
- Market expansion outside the US and new indications will support future revenue.
FAQs
Q1: How soon could biosimilars impact Repatha’s pricing?
A: Biosimilar candidates are under FDA review, with potential market entry by 2025–2026.
Q2: What factors influence Repatha's market share growth?
A: Approval for additional indications, payer coverage strategies, and patient affordability.
Q3: Are there any upcoming regulatory changes that could affect price?
A: Potential policy shifts toward value-based pricing and biosimilar adoption.
Q4: How does Repatha compare with Praluent in pricing and market share?
A: Repatha has higher market share and a slightly higher list price, but both face market pressures.
Q5: What is the outlook for global sales?
A: Global sales are expected to grow, especially in Europe and Asia, aligning with broader access initiatives and approval expansions.
References:
[1] MarketWatch. (2022). PCSK9 inhibitors market size and forecast.
[2] Amgen. (2022). Repatha product information sheet.
[3] IQVIA. (2022). US Prescription Data Report.
[4] FDA. (2022). Biosimilar guidance documents.
