Last updated: March 13, 2026
What Is NDC 60505-0134?
National Drug Code (NDC) 60505-0134 is identified as Repatha (evolocumab), a PCSK9 inhibitor indicated for lowering LDL cholesterol in adults with hyperlipidemia or clinical atherosclerotic cardiovascular disease. Produced by Amgen, Repatha launched on the market in 2015.
Market Overview
Market Size and Growth
The global lipid-lowering drug market was valued at approximately USD 18 billion in 2022. It is expected to grow at a compound annual growth rate (CAGR) of 6% from 2023 to 2030, driven by increasing cardiovascular disease prevalence and enrollment of high-risk patient populations.
Repatha's Market Position
Repatha commands a significant share within the PCSK9 inhibitor segment, alongside competitor Praluent (alirocumab). The market is increasingly competitive as biosimilars or alternative therapies enter development, although notable patent protections limit immediate biosimilar threat.
Patient Population
Estimate of eligible patients:
| Criteria |
Details |
| Adults with atherosclerotic cardiovascular disease |
20 million in the U.S. |
| Patients with familial hypercholesterolemia |
1 million in the U.S. |
| Patients on maximally tolerated statins and LDL > 70 mg/dL |
~5 million |
Portraying this, approximately 25 million patients potentially qualify for Repatha therapy in the U.S. alone.
Insurance Coverage and Market Penetration
Repatha's adoption depends heavily on insurance reimbursement. In 2022, coverage policies saw improvements, with approximately 80% of commercial plans covering PCSK9 inhibitors, though prior restrictions limited access.
Price Trajectory and Projections
Current Pricing
The wholesale acquisition cost (WAC) for Repatha is approximately $5,850 per month for standard dosing (140 mg biweekly). Actual net prices are lower after rebates and discounts, estimated at around $4,600 per month.
| Parameter |
Value |
| WAC (2023) |
$5,850/month |
| Estimated net price |
$4,600/month |
| Annual cost |
~$55,200 |
Volume Trends
In 2022, approximately 150,000 patients in the U.S. were on Repatha, representing a penetration rate of roughly 2-3% of eligible patients. Market growth in patient numbers is driven by increasing awareness, expanded indications, and favorable payor coverage.
Price Projections
Factors influencing future pricing include:
- Patent protections: Repatha’s main patents expire in 2026, potentially allowing biosimilar competition thereafter.
- Negotiation dynamics: PBMs and payors may push for discounts, potentially reducing net prices to around $3,500–$4,000/month by 2025.
- Market entry of biosimilars or generics: These could lower prices further by 2027, possibly to $2,500–$3,000/month.
Assuming steady inflation-adjusted increases, with the potential for discounts, the average annual net cost could decline from current levels to approximately $50,000 by 2025 and $35,000–$40,000 by 2027.
Competitive Landscape
| Product |
Competitor |
Market Share (2022) |
Price (Estimated) |
Indications |
| Repatha (evolocumab) |
Amgen |
60% |
$4,600/month (net) |
Hyperlipidemia, ASCVD |
| Praluent (alirocumab) |
Sanofi |
30% |
$4,300/month (net) |
Similar indications |
| Biosimilar PCSK9 inhibitors |
Various |
<10% |
Expected <$3,000/month post-2026 |
Under development |
Regulatory and Policy Factors
- The FDA approved Repatha for use in children with heterozygous familial hypercholesterolemia in 2021.
- Policy changes favoring value-based pricing could pressure prices downward.
- The upcoming patent expiration in 2026 opens the door for biosimilar competition, expected to influence market share and pricing.
Key Developments Impacting Market and Pricing
- Expanded clinical indications increase eligible patient pool.
- Negotiation trends favor price reductions.
- Biosimilar approvals forecasted post-2026 will likely lead to significant price declines.
- Greater use of generic and biosimilar alternatives expected to diminish Repatha's market share.
Key Takeaways
- Repatha has a dominant position among PCSK9 inhibitors but faces coming biosimilar competition after 2026.
- Current net prices hover around $4,600/month; future prices may decline to $3,500–$4,000/month by mid-decade.
- Market growth will depend on expanding indications and payor reimbursement policies.
- Pricing pressure will intensify post-2026 with biosimilar entries, possibly reducing drug costs by 30–50%.
FAQs
1. What factors will most influence Repatha's future price?
Patent expiration, biosimilar competition, payor negotiations, and clinical adoption levels.
2. How does Repatha compare to Praluent in pricing and efficacy?
Pricing is similar, with net costs around $4,300–$4,600/month. Both drugs offer comparable efficacy; choice often depends on physician and patient preferences.
3. What is the projected timeline for biosimilar competition?
Biosimilar approvals could occur as early as 2026–2027, with price reductions likely following within 1–2 years.
4. How significant is the patient population for Repatha in the U.S.?
Approximately 25 million adults qualify, but current usage covers only 0.6%–1% of this group.
5. What impact might policy changes have on pricing?
Value-based agreements and price negotiations are likely to drive prices downward, especially post-patent expiry.
References
- Grand View Research. (2023). Lipid-Lowering Drugs Market Size, Share & Trends Analysis Report.
- U.S. Food & Drug Administration. (2021). Drug Approvals and Indications.
- IQVIA. (2022). National Drug Data File.
- Amgen Inc. (2023). Repatha Prescribing Information.
- Kaiser Family Foundation. (2022). Health Insurance Coverage Data.
