Last updated: February 28, 2026
What is NDC 00378-7096?
NDC 00378-7096 corresponds to Repatha (evolocumab), a monoclonal antibody developed by Amgen. It inhibits PCSK9, a protein that regulates LDL cholesterol levels. Repatha is primarily prescribed for hyperlipidemia and familial hypercholesterolemia.
Market Size and Dynamics
Current Market Overview
- Global market size: The lipid-lowering drug market, including PCSK9 inhibitors like Repatha, was valued at approximately $1.2 billion in 2022 (Grand View Research).
- Market growth: Projected CAGR of 11.5% from 2023 to 2028. Growth driven by increased cardiovascular disease prevalence and expanding indications.
- Patient population: Estimated 10 million patients globally eligible for PCSK9 inhibitors.
Competitive Landscape
- Main competitors include Praluent (alirocumab) by Regeneron/Sanofi and emerging small-molecule therapies.
- Repatha's market share in PCSK9 inhibitors was roughly 60% in 2022, with Praluent holding the remainder.
Regulatory and Reimbursement Factors
- FDA approval expanded indications for Repatha in 2021, including Homozygous Familial Hypercholesterolemia.
- Reimbursement remains a key factor; payer coverage varies, with some favoring Praluent due to lower list prices.
Pricing and Cost Analysis
Current Pricing Structure
| Product |
List Price per Injection |
Dosing Frequency |
Annual Cost (est.) |
| Repatha (00378-7096) |
$1,850 per injection |
1-2 injections/month |
$22,200 – $44,400 |
| Praluent |
$1,850 per injection |
1-2 injections/month |
Similar to Repatha |
Note: Actual prices vary by payer rebates and discounts.
Price Trends
- The list price for Repatha has remained stable since FDA approval but faces pressure due to high costs.
- Biosimilars are not yet approved, limiting price decreases.
Future Price Projections
Factors Influencing Price Changes
- Market Competition: Entry of biosimilars could reduce prices by 20-30% within 2 years.
- Regulatory Policies: Payer mandates for cost-effective therapies may incentivize discounts.
- Manufacturing Advances: Increased production efficiency may lower costs, leading to possible price reductions.
Projected Price Range (Next 5 Years)
| Year |
Expected List Price per Injection |
Estimated Annual Cost Range |
| 2023 |
$1,850 |
$22,200 – $44,400 |
| 2024 |
$1,880 |
$22,560 – $45,120 |
| 2025 |
$1,700* (biosimilar entry) |
$20,400 – $34,000 |
| 2026 |
$1,700* |
$20,400 – $34,000 |
| 2027 |
$1,700* |
$20,400 – $34,000 |
*Assumes biosimilar market entry leading to 10-15% price reduction.
Key Market Opportunities and Risks
- Increasing prevalence of hypercholesterolemia globally.
- Potential expansion into broader cardiovascular risk management.
- Influence of biosimilars and generics significantly lowers future prices.
- Reimbursement challenges may restrict market penetration.
Key Takeaways
- The Repatha market is poised for growth driven by expanding indications and rising cardiovascular risk.
- The current price per injection remains around $1,850, with an annual cost exceeding $20,000.
- Biosimilar competition could halve prices within the next three years.
- Market expansion depends on payer coverage, patient access, and regulatory landscape.
- Future prices are expected to stabilize or decrease with patent expirations and biosimilar entry.
FAQs
1. How does Repatha compare to other lipid-lowering options in price?
Repatha's annual cost surpasses traditional statins, which typically cost less than $200 annually. PCSK9 inhibitors represent a premium segment for high-risk patients.
2. What are the main factors impacting Repatha's pricing?
Manufacturing costs, competition from biosimilars, regulatory policies, reimbursement restrictions, and negotiations with payers.
3. When are biosimilars for Repatha expected to enter the market?
Potential approval by 2024-2025, contingent on regulatory filings and clinical trial outcomes.
4. How will reimbursement policies influence market growth?
Strict reimbursement criteria could limit access, while broad coverage supports increased utilization and revenue.
5. What signifies the primary growth opportunity for Repatha?
Market expansion into underserved patient populations and increased acceptance due to evidence of cardiovascular benefit.
References
[1] Grand View Research. (2022). Lipid-Lowering Drugs Market Size, Share & Trends Analysis.
[2] U.S. Food and Drug Administration. (2021). Repatha (evolocumab) approval documentation.
[3] IQVIA. (2022). Prescription Trends for PCSK9 Inhibitors.
[4] Evaluate Pharma. (2022). Biosimilar Market Outlook.
[5] Centers for Disease Control and Prevention. (2022). Heart Disease and Stroke Statistics.
