Last updated: February 24, 2026
What is the drug associated with NDC 82584-0001?
NDC 82584-0001 is associated with Evolocumab, a monoclonal antibody marketed under the brand name Repatha. It is indicated for lowering LDL cholesterol in patients with familial hypercholesterolemia or those at high cardiovascular risk.
What is the current market landscape for Evolocumab (Repatha)?
Market positioning
Repatha holds a significant position within the PCSK9 inhibitor class, rivaling Amgen's Alirocumab (Praluent). As of 2023, the drug addresses a niche of high-risk, statin-intolerant, or familial hypercholesterolemia patients.
Market size
- The global PCSK9 inhibitors market was valued at approximately USD 3.2 billion in 2022.
- It projects a compound annual growth rate (CAGR) of 11.5% from 2023 to 2030.
- The U.S. accounts for nearly 70% of the market, driven by high cardiovascular disease prevalence and expansive insurance coverage.
Competitive landscape
| Drug |
Company |
Approval Year |
Estimated 2022 Sales |
Pricing (per year) |
Dosage Schedule |
| Repatha (Evolocumab) |
Novartis (originally Amgen) |
2015 |
USD 1.2 billion |
USD 14,100 |
140 mg every 2 weeks or 420 mg monthly |
| Praluent (Alirocumab) |
Sanofi |
2015 |
USD 700 million |
USD 14,600 |
75 mg every two weeks, can increase to 150 mg |
Regulatory and reimbursement factors
- Repatha received FDA approval in 2015.
- Continued expansion in Medicare Part D and commercial insurance coverage enhances accessibility.
- Patent protections extend until at least 2030 in key territories, influencing pricing strategies.
What are the price projections for NDC 82584-0001?
Historic pricing trends
- Post-approval, annual list prices hovered between USD 14,100 and USD 14,600.
- Discounting and negotiations reduce actual net prices. Estimates suggest net prices are approximately 30-40% lower than list prices.
Projected pricing trends (2024-2030)
| Year |
Estimated List Price (USD) |
Anticipated Net Price (USD) |
Comments |
| 2024 |
USD 14,200 |
USD 8,500–10,000 |
Slight decrease due to payer negotiations |
| 2025 |
USD 14,200 |
USD 8,500–10,000 |
Patent protections remain in effect |
| 2026 |
USD 14,200 |
USD 8,500–10,000 |
Introduction of biosimilars unlikely before 2030 |
| 2027–2030 |
Remains stable |
Slight downward pressure |
Marginal declines as competition and biosimilars emerge |
Key factors influencing prices
- Biosimilar entry: No biosimilars in the U.S. anticipated before 2028.
- Reimbursement policies: Increased utilization depends on favorable insurance negotiations.
- Manufacturing costs: Stable, given the biologic nature of the drug.
- Patent expiry: No patent expiry before 2030, supporting stable pricing.
What are the market risks and growth drivers?
Risks
- Biosimilar competition could lower prices significantly post-2030.
- Regulatory changes that restrict reimbursement could impact sales.
- Market saturation in the high-risk cardiovascular segment may limit growth.
Drivers
- Rising prevalence of hypercholesterolemia and cardiovascular disease.
- Growing awareness and screening programs.
- Approval of expanded indications, such as formulations for broader patient populations.
Summary table
| Aspect |
Key Data |
| Market size (2022) |
USD 3.2 billion |
| CAGR (2023-2030) |
11.5% |
| U.S. market share |
70% |
| 2022 sales |
USD 1.2 billion |
| List price (2024 projection) |
USD 14,200 |
| Estimated net price (2024) |
USD 8,500–10,000 |
| Patent expiry |
No expiry before 2030 |
Key Takeaways
- NDC 82584-0001 (Evolocumab) remains a high-value, premium-priced biologic in the PCSK9 inhibitor class.
- The market will likely sustain steady growth through 2030, driven by increasing cardiovascular disease prevalence.
- Pricing stability expects a slight decline due to payer negotiations, with no biosimilar threat before 2028.
- The primary competitive pressure will arise from biosimilar entrants post-2030, potentially lowering prices.
- Reimbursement policies will strongly influence market penetration and revenue dynamics.
FAQs
Q1: How could biosimilars impact pricing after 2028?
A1: Biosimilars are expected to introduce competition, which could reduce list prices by 30-50%, lowering net prices significantly.
Q2: Are there geographic price variations for Evolocumab?
A2: Yes, pricing varies globally based on healthcare systems, reimbursement policies, and negotiated discounts.
Q3: What factors could accelerate market growth?
A3: Expanded indications, increased screening, and new formulations could raise patient eligibility and utilization.
Q4: Could new therapies replace Evolocumab in the future?
A4: Emerging treatments targeting lipid metabolism or gene therapy approaches may compete, but regulatory approvals and adoption timelines remain uncertain.
Q5: What is the patent landscape for Evolocumab?
A5: Patents protect the drug until at least 2030, delaying biosimilar entry and supporting current pricing structures.
References
[1] MarketWatch. (2023). PCSK9 inhibitors market size and forecast.
[2] Evaluate Pharma. (2022). Prescription drugs sales database.
[3] FDA. (2015). Biologics approval for Repatha.
[4] IQVIA. (2023). U.S. drug pricing and reimbursement trends.
[5] Mizuho Securities. (2023). Biosimilar entry forecasts in the US.
