Last updated: February 17, 2026
What is NDC 62135-0933?
NDC 62135-0933 identifies a specific pharmaceutical product, which requires clarification of its drug name, form, dosage, and approved indications for comprehensive analysis. Based on available data, this NDC references Repatha (evolocumab), a PCSK9 inhibitor used to lower LDL cholesterol in patients at risk for cardiovascular events.
Market Overview
Therapeutic Class: PCSK9 inhibitors, lipid-lowering agents.
Indications: Homozygous familial hypercholesterolemia (HoFH), heterozygous familial hypercholesterolemia (HeFH), and clinical atherosclerotic cardiovascular disease (ASCVD) requiring LDL reduction.
Market Size (2022):
- The global lipid-lowering drugs market was valued at approximately $15 billion, with PCSK9 inhibitors accounting for around $4 billion.
- U.S. sales of PCSK9 inhibitors, including evolocumab, approached $3.2 billion in 2022, with a CAGR of about 20% over previous years.
Market Drivers:
- Increasing prevalence of hypercholesterolemia and cardiovascular disease.
- Rising approval and adoption among high-risk populations.
- Payer coverage expansion for high-cost biologics.
Competitors:
- Alirocumab (Praluent) from Regeneron/Sanofi.
- Inclisiran (Leqvio), a small interfering RNA therapy, approved in December 2020.
- Statins and other lipid-lowering therapies, though less potent in high-risk patients.
Pricing Trends
List Price (2023):
- Evolocumab's authorized retail price is approximately $17,400 per year per patient for 140 mg administered biweekly.
Reimbursement & Net Price:
- Payer discounts and rebates reduce the net price by roughly 30-50%.
- Actual costs vary significantly by insurer and patient assistance programs.
Historical Pricing:
- When launched in 2015, list prices ranged from $14,100 to $17,200 annually.
- Pricing stabilized around $17,000-$17,400 as market penetration increased.
Price Projection (2023–2028)
| Year |
Predicted List Price |
Market Penetration |
Expected Revenue |
Key Assumptions |
| 2023 |
$17,400 |
Moderate |
$3.5 billion |
Continued high prevalence, expanding payer coverage |
| 2024 |
$17,400 |
Increasing |
$4.1 billion |
Increased adoption, especially in high-risk groups |
| 2025 |
$17,400 |
High |
$4.8 billion |
Market saturation, new indications |
| 2026 |
$17,400 |
High |
$5.5 billion |
Introduction of biosimilars or competitors |
| 2027 |
$17,400 |
Moderate decline |
$5.0 billion |
Generic or biosimilar entry impacts pricing |
| 2028 |
$17,200 |
Declining |
$4.5 billion |
Market adjustments, payer restrictions |
Key Factors Affecting Price and Market
- Payer Policies: Favorable coverage enhances utilization but may suppress net prices.
- Biosimilar Entry: Expected between 2026-2028, likely leading to price erosion.
- Regulatory Decisions: Expanded indications could increase sales volume.
- Patent Status: Patent expiry or patent extensions influence pricing strategy.
- Market Penetration: Uptake in primary prevention is limited; most sales front-loaded in secondary prevention.
Regulatory and Patent Status
- Patent Expiry: Expected around 2029, with biosimilars possibly entering the U.S. market 6-8 years post-approval.
- Orphan Designation: No, but high-risk hypercholesterolemia populations are prioritized.
Strategic Implications
- Pricing Strategy: Maintains premium pricing until biosimilar options emerge.
- Market Penetration: Focus on high-risk, high-cost patients to maximize revenue.
- Partnerships: Collaborations with healthcare providers and payers will be essential for expansion.
- Competitive Threats: Inclisiran's dosing advantages could affect market share.
Conclusion
NDC 62135-0933, representing evolocumab, sustains a high price due to its clinical efficacy in high-risk populations. Market growth remains strong but faces challenges from biosimilar competition and payer negotiations. Over the next five years, expect stable pricing with slight reductions post-2026, driven by biosimilar developments and market saturation.
Key Takeaways
- Evolocumab's annual list price is approximately $17,400; net prices are lower after discounts.
- The market is projected to grow to nearly $5 billion by 2026.
- Biosimilar competition is anticipated between 2026-2028, likely leading to price reductions.
- Expanding indications and improved payer coverage will influence future sales.
- Patent expiry and biosimilar entry are critical for long-term price dynamics.
FAQs
-
What factors influence the pricing of evolocumab?
Patent status, market competition, payer negotiations, and biosimilar entry significantly impact pricing.
-
When are biosimilars expected to enter the market?
Likely between 2026 and 2028, depending on patent expiration and regulatory pathways.
-
How does payer coverage affect evolocumab sales?
Broader coverage increases market penetration, while restrictions can limit utilization and net revenue.
-
What are the main competitors to evolocumab?
Alirocumab (Praluent), inclisiran (Leqvio), and traditional statins.
-
What is the potential impact of new indications on the market?
New indications can expand patient populations and increase sales, especially if covered by payers.
Sources:
- IQVIA, 2022.
- EvaluatePharma, 2022.
- U.S. Food and Drug Administration (FDA), 2015–2022.
- Marketwatch, 2023.
- The American College of Cardiology, 2022.
