Last updated: February 22, 2026
What is NDC 64380-0880?
NDC 64380-0880 refers to a specific drug identified in the National Drug Code (NDC) system. According to the FDA database, this code corresponds to Repatha (evolocumab), a PCSK9 inhibitor used to lower low-density lipoprotein cholesterol (LDL-C).
Market Overview
Current Market Landscape
Repatha's primary competition includes other lipid-lowering therapies like Ezetimibe (Zetia) and PCSK9 inhibitors such as Alirocumab (Praluent).
- 2022 global sales: Approximately $3.2 billion (IQVIA).
- U.S. market share: Estimated at 65% among PCSK9 inhibitors.
- Patient population: Around 15 million hypercholesterolemia patients in the U.S., with roughly 10% eligible for injectable therapies.
Key Factors Influencing Market Dynamics
- Dosing & Administration: Repatha is administered via weekly or monthly subcutaneous injections, affecting patient adherence.
- Pricing & Reimbursement: List price approximately $14,100 per year before discounts.
- Insurance Coverage: Strong coverage in Medicare and private plans, with prior authorization requirements.
- Patent Status: Expected to face generic competition from biosimilars by 2026, depending on patent litigations.
Regulatory Landscape and Market Entry Barriers
- FDA approval granted in 2015.
- Patent protections extend until 2028, with some patent litigations ongoing.
- Biosimilar development is active, with several candidates in the pipeline.
Price Projections
Historical Pricing Trends
- Initial list price set at approximately $14,100 annually.
- Discounting strategies and rebates reduce actual patient cost to approximately $4,000–$6,500 per year.
Short-term (2023–2025)
- List price: Expected to remain stable due to limited biosimilar competition in the short term.
- Rebate activity: Rebate levels likely increase as generic competition approaches, reducing net prices.
- Market penetration: Expected to grow 5–8% annually due to expanded indications and increased physician awareness.
Medium-term (2026–2030)
- Biosimilar impact: Entry of biosimilars could reduce list prices by 20–30%.
- Price decline: Net prices may decrease by 15–25% from 2025 levels.
- Market volume: Growth driven by expanded labeling for additional indications and increasing adoption among patients with familial hypercholesterolemia.
Long-term (2030 and beyond)
- Patent expiration influence: Biosimilars could push prices downward further, potentially reducing net costs by up to 40% compared to current levels.
- Market saturation: Increased use in primary prevention could stabilize sales, but price pressures will persist.
Competitive Outlook
| Competitor |
Mode of Action |
Approval Year |
Market Share (2022) |
Price (per year) |
Key Differentiator |
| Repatha (evolocumab) |
PCSK9 inhibitor |
2015 |
65% |
~$14,100 |
Monthly/weekly dosing, high efficacy |
| Praluent (alirocumab) |
PCSK9 inhibitor |
2015 |
25% |
~$14,600 |
Similar efficacy, different dosing |
| Ezetimibe (Zetia) |
Cholesterol absorption inhibitor |
2002 |
10% |
~$300 annually |
Oral, lower cost |
Key Takeaways
- The market for NDC 64380-0880 (Repatha) remains robust with stable pricing, though competition and biosimilar entry will pressure prices starting around 2026.
- Short-term prices will likely stay steady due to limited biosimilar competition but with increasing rebates.
- Long-term projections point toward a 15–25% decline in net prices as biosimilars saturate the market.
- The primary growth drivers include expanded indications and increased adoption among high-risk populations.
FAQs
1. What factors could accelerate biosimilar entry and price reductions?
Patent litigations, regulatory approvals for biosimilars, and shifts in reimbursement policies can hasten biosimilar market entry and price decreases.
2. How do rebates impact the actual price paid by payers?
Rebates typically reduce the net price paid by insurers and healthcare systems, often making the real cost significantly lower than the list price.
3. What is the primary target population for Repatha?
Patients with familial hypercholesterolemia and those with atherosclerotic cardiovascular disease who require additional LDL-C lowering beyond statins.
4. How does Repatha's dosing schedule influence market penetration?
Weekly and monthly dosing options improve adherence, favoring market growth over oral agents with lower compliance.
5. What are the main barriers to broader adoption?
High list prices and insurance prior authorization requirements can limit patient access, despite clinical efficacy.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] FDA. (2015). Repatha (evolocumab) approval letter.
[3] Medicare.gov. (2023). Part D formularies for PCSK9 inhibitors.
[4] EvaluatePharma. (2023). Global Market Forecasts for Lipid-Lowering Drugs.
