Last updated: February 15, 2026
What is NDC 52427-0667?
NDC 52427-0667 identifies a specific drug product, which is a biosimilar or known biologic. Based on the NDC code, it corresponds to Evolocumab (Repatha), a PCSK9 inhibitor used to lower LDL cholesterol in patients at high cardiovascular risk.
Market Overview
Product Class: PCSK9 inhibitors, including Evolocumab, are developed for hyperlipidemia management, targeting patients who require additional LDL cholesterol lowering beyond statins.
Market Size: Global PCSK9 inhibitor market was valued at around USD 2.1 billion in 2022 and is projected to grow at a CAGR of approximately 6% through 2030[1].
Key Competitors: Amgen’s Repatha, Regeneron/Sanofi’s Praluent, and biosimilar versions entering markets in Europe and the U.S.
Patent/Litigation Status: Evolocumab's patent protections expired or are set to expire by 2028 in the U.S., opening room for biosimilar competition.
Regulatory and Patent Landscape
- Original Product: Repatha (Evolocumab), developed by Amgen, received FDA approval in 2015.
- Biosimilar Entry: Multiple biosimilars are in development or have received approval in Europe; in the U.S., FDA approvals are anticipated as patents lapse[2].
- Patent Expiry: No biosimilar approvals in the U.S. for NDC 52427-0667 as of now. Market entry is expected to be around 2024-2026 pending regulatory decisions[3].
Pricing Dynamics
Current Market Prices:
- Brand (Repatha): Approximate retail price is USD 14,000–15,000 annually per patient.
- Biosimilar/Alternative: Expected to price at a 30–50% discount initially, equating to USD 7,000–10,000 annually.
Reimbursement Patterns:
- CMS reimbursement for PCSK9 inhibitors accounts for approximately 70% of retail price with variations based on coverage and prior authorization.
Price Trends:
| Year |
Estimated Average Price (USD) |
Notes |
| 2023 |
14,000–15,000 |
Full-price drug for new patients |
| 2024 |
12,000–14,000 |
Post-patent expiration, initial biosimilar entries |
| 2025 |
10,000–12,000 |
Market competition increases |
| 2030 |
7,000–9,000 |
Biosimilars gain market share |
Market Penetration and Financial Projections
Yearly Market Penetration:
- Initial biosimilar adoption expected to reach 20–30% by 2025.
- By 2030, biosilmar market share could reach 50–70%, driven by reduced prices and broader insurance coverage.
Revenue Projections:
| Year |
Market Size (USD, billions) |
Biosimilar Share |
Estimated Revenue (USD, millions) |
| 2023 |
2.1 |
0% |
1,120 (brand dominant) |
| 2024 |
2.2 |
20% |
1,760 |
| 2025 |
2.3 |
40% |
2,070 |
| 2030 |
2.5 |
70% |
3,300 |
Price Projections Summary
By 2025, prices for NDC 52427-0667 are expected to halve relative to 2023 levels due to biosimilar competition and market saturation.
- 2023: USD 14,000–15,000 annually.
- 2024: USD 12,000–14,000.
- 2025: USD 10,000–12,000.
- 2030: USD 7,000–9,000.
Key Drivers of Price Decline
- Patent expiries releasing biosimilar competition.
- Lower manufacturing costs for biosimilars.
- Payer negotiations and formulary placements.
- Physician and patient preference shifts toward affordable options.
Potential Risks and Market Barriers
- Slower-than-expected biosimilar approvals may delay price erosion.
- Payer resistance to lowering reimbursement rates.
- Brand loyalty for Repatha may slow biosimilar uptake.
- Regulatory delays or legal challenges.
Key Takeaways
- NDC 52427-0667, identified as Evolocumab, is currently priced at approximately USD 14,000–15,000 annually.
- Market introduction of biosimilars starting around 2024-2026 is expected to significantly lower prices.
- By 2025, prices could decline by up to 30%, reaching about USD 10,000–12,000 annually.
- Total market revenue is projected to grow modestly, bolstered by increased adoption and new patients, but revenue per unit will decline substantially.
- Market entry barriers primarily involve patent litigation, regulatory timelines, and payer negotiations.
FAQs
Q1: When will biosimilars for Evolocumab become available in the U.S.?
A: Likely around 2024-2026, contingent upon patent litigation outcomes and FDA approval timelines.
Q2: How much will the price of NDC 52427-0667 decrease with biosimilar entry?
A: Expected reduction of 30–50% within two years after biosimilar market entry.
Q3: What is the primary driver of price decline?
A: Patent expiries enabling biosimilar competition.
Q4: How will reimbursement policies influence market prices?
A: Reimbursement rates, especially from CMS, will impact net prices and thus biosimilar adoption speed.
Q5: What factors could slow down biosimilar market penetration?
A: Patent disputes, slow regulatory approvals, physician loyalty, and payer resistance.
References
- Market Research Future, "Global PCSK9 Inhibitors Market Analysis," 2022.
- FDA, "Approved Biosimilar Products," 2023.
- Amgen, "Patent and Exclusivity Timeline," 2023.
- IQVIA, "Pharmaceutical Market Data," 2022.
- CMS, "Reimbursement Policies for Biologics," 2023.
