Last updated: February 13, 2026
What Is the Drug Associated With NDC 43598-0267?
NDC 43598-0267 corresponds to Evolocumab (Repatha). It is a PCSK9 inhibitor used to lower LDL cholesterol levels in patients with hyperlipidemia or cardiovascular risk. The drug is marketed by Amgen and approved by the FDA for familial hypercholesterolemia and atherosclerotic cardiovascular disease.
What Is the Current Market Size?
Global Market Context
- The PCSK9 inhibitor market reached approximately $2.4 billion in 2022.
- Growth rate projected at 16% CAGR from 2023-2028.
- Key drivers: increasing prevalence of cardiovascular disease, high LDL cholesterol, and unmet needs in statin-intolerant populations.
Market Segmentation
| Segment |
Estimated 2022 Revenue |
CAGR (2023-2028) |
Notes |
| Prescribed for FH and ASCVD |
$1.8 billion |
15-17% |
Dominates revenue, multiple formulations |
| Non-prescription use |
Emerging |
N/A |
Limited, geographies vary |
How Does Pricing Compare?
List Price in the US (2023)
- Repatha 140 mg/1 mL autoinjector: Approx. $6,300 per year (one injection every two weeks).
- Cost per dose varies from $3,150 to $6,300 depending on dosing frequency and patient requirements.
Insurance and Rebates
- Actual out-of-pocket costs decrease with insurance coverage, rebates, and pharmaceutical assistance programs.
- Average net price to payers is estimated at $4,400–$5,500 per patient annually.
International Pricing Trends
- Prices vary significantly.
- In Europe, the average price ranges from €3,000–€4,500 ($3,200–$4,800) annually.
- Variations depend on national negotiations, healthcare systems, and patent status.
What Are Projected Market and Price Trends?
Market Growth Projections
- By 2028, the PCSK9 inhibitor market could approach $4.4 billion.
- Growth driven by increased adoption, new indications, and ongoing clinical trials.
Pricing Outlook
- Price reductions are expected as biosimilars and biosimilar-like developments progress.
- The potential entry of alternative therapies could further pressure prices.
- Payer negotiations and value-based pricing models may reduce net prices globally.
Potential Price Trends by 2028
| Scenario |
Estimated Price Range |
Drivers |
| Stable pricing |
$5,000–$6,500 (US) |
Patent exclusivity, limited biosimilar competition |
| Price reduction with biosimilars |
$3,500–$4,500 (US) |
Biosimilar approvals increasing between 2025-2028 |
| Significant reduction |
<$3,000 (US) |
Major biosimilar market entry, policy shifts |
What Influences Future Price Dynamics?
- Patent Status: Patent expiry expected around 2029; biosimilar development accelerates.
- Regulatory Environment: Faster approvals for biosimilars and generics could lower prices.
- Healthcare Policies: Value-based contracting and outcome-based pricing become more prevalent.
- Market Penetration: Framing therapy as initial or second-line impacts volume and revenue.
Key Takeaways
- NDC 43598-0267 (Repatha) is a high-efficacy LDL-lowering drug with an established market but faces imminent pricing pressures.
- Market size reached $2.4 billion in 2022, with continuous growth expected.
- US list prices are around $6,300 annually, with net prices reduced via rebates and assistance programs.
- International prices are lower but vary widely.
- Future pricing will be influenced by biosimilar competition, patent expiration, and healthcare policy changes, potentially reducing prices by approximately 30–50% by 2028.
FAQs
1. When is patent expiration for Repatha?
The original patent is expected to expire around 2029, opening the market to biosimilars.
2. What biosimilars are in development or approved?
As of early 2023, several biosimilar candidates are in various stages of development, with some expected approval by 2025-2026.
3. How does the efficacy of Repatha compare to statins?
Repatha offers significant LDL reduction (~60%), especially valuable for statin-intolerant or high-risk patients.
4. What are the key reimbursement challenges?
Reimbursement varies globally; US payers often negotiate rebates, affecting net prices. Politicized health policies may influence future coverage.
5. How might new lipid-lowering therapies impact the market?
Emerging treatments like inclisiran and gene-editing options could compete with Repatha, influencing volume and pricing strategies.
References
- MarketResearch.com, "Global PCSK9 Inhibitors Market," 2022.
- IQVIA Reports, "Prescription Drug Price and Usage Trends," 2023.
- FDA Label for Evolocumab (Repatha), 2019.
- Amgen Annual Report, 2022.
- European Medicines Agency Approvals, 2022.
