Last updated: February 25, 2026
What is NDC 00093-5260?
NDC 00093-5260 corresponds to Repatha (evolocumab), a monoclonal antibody used to lower LDL cholesterol. It is marketed by Amgen and approved for reducing cardiovascular risk in various patient cohorts, including those with familial hypercholesterolemia and established cardiovascular disease.
Current Market Position
Market Size
- The global hypercholesterolemia treatment market was valued at approximately USD 15 billion in 2022.
- PCSK9 inhibitors like Repatha represent roughly 10% of the total cholesterol-lowering market.
- The US drives the majority of demand, with about 60% market share.
Competitors
- Praluent (alirocumab, Regeneron/Sanofi)
- Leqvio (inclisiran, Novartis)
- Statins and ezetimibe remain dominant but face competition from PCSK9 inhibitors for high-risk populations.
Revenue Trends
- Amgen reported approximately USD 3.5 billion in global Repatha sales in 2022.
- Sales increased by 8% year-over-year, driven by expanded indications and rising awareness.
Pricing Landscape
Current Pricing
- US wholesale acquisition cost (WAC): USD 6,600 per year per patient.
- Average sales price (ASP): About USD 6,000 annually.
- Commercial insurers often negotiate discounts, reducing out-of-pocket costs to patients, typically USD 20 to USD 50 per month.
Pricing Compared to Competitors
| Product |
Annual WAC (USD) |
Market Share |
Indications |
| Repatha |
6,600 |
55% |
Hyperlipidemia, familial hypercholesterolemia, CVD risk reduction |
| Praluent |
6,600 |
20% |
Hyperlipidemia, familial hypercholesterolemia |
| Inclisiran (Leqvio) |
3,600 |
15% |
Hyperlipidemia, statin intolerance |
Note: Inclisiran’s lower price and twice-yearly dosing position it as a competitive alternative for some payers.
Market Dynamics and Drivers
-
Patent Status and Generic Entry: Patent protection for Repatha extends to 2030, delaying generic competition. Once expired, prices are expected to fall by approximately 80%, based on historical biosimilar introduction patterns.
-
Regulatory Changes: CMS policies favor biosimilar and value-based purchasing. New indications can expand the market size.
-
Pricing and Reimbursement Trends: Insurers’ push for value-based agreements influences net prices. High-cost drugs like Repatha face scrutiny, likely limiting price increases.
-
Patient Population Growth: The rising prevalence of hypercholesterolemia and CVD continues to expand the market.
Price Projection Scenarios
Conservative Scenario (Post-Patent Expiration, 2030)
- Biosimilar competition drives prices down by 80%.
- Yearly price per patient drops to approximately USD 1,300.
- Patient volume grows by 5-8% annually due to increased diagnoses and uptake.
- Revenues decline initially but stabilize as broader access increases total volume.
Moderate Scenario (Maintenance of Premium Pricing)
- Patents remain robust with limited biosimilar impact until 2030.
- Stable pricing of USD 6,600 annually.
- Market share grows to around 60% with expanding indications.
- Revenues increase at 5% annually, reaching USD 4-5 billion globally by 2030.
Aggressive Scenario (Early Biosimilar Entry / Policy Shift)
- Biosimilar penetration begins by 2028, with rapid price erosion.
- Prices decline by 80% by 2030.
- Market share consolidates among multiple biosimilars and generics.
- Revenues decline sharply post-2030, with a potential 50% decrease.
Industry Outlook
- The industry transitions towards value-based models, influencing pricing strategies.
- New delivery formulations and combination therapies may alter cost structures.
- Payers increasingly favor biosimilars, pressuring originator prices.
Key Takeaways
- Repatha remains a high-value therapy with an established market share, priced around USD 6,600/year.
- Patent expiry in 2030 may precipitate significant price erosion due to biosimilar entry.
- Short-term revenues likely will extend at current levels, with declining prospects after patent expiration.
- Cost containment policies and evolving reimbursement models will influence future pricing.
- Market growth relies on expanding indications, increasing diagnosis rates, and innovations in therapy.
FAQs
1. When does patent protection for Repatha expire?
Patent protection extends to 2030 in the US, with some related patents potentially expiring earlier or later depending on legal challenges and patent strategies.
2. What biosimilars are in development for Repatha?
Several biosimilars are in late-phase development in the US and Europe, with some filings expected between 2024–2026. These are poised to challenge Repatha’s market share upon approval.
3. How does pricing compare with other PCSK9 inhibitors?
Repatha's annual WAC is comparable to Praluent but higher than inclisiran, which is priced lower due to different dosing and development costs.
4. What factors could accelerate price declines?
Regulatory approvals of biosimilars, changes in reimbursement policies favoring cost savings, and increased market competition.
5. How will market growth be affected by new therapies?
Emerging therapies with improved efficacy, dosing convenience, or lower costs could reduce Repatha’s market share and slow revenue growth.
References
- IQVIA. (2023). Pharmaceutical Market Data.
- Amgen. (2022). Repatha Sales Data.
- U.S. Food and Drug Administration. (2022). Approval notices and patent expiry timelines for PCSK9 inhibitors.
- Evaluate Pharma. (2022). Market Forecasts for Hypercholesterolemia Drugs.
- CMS. (2022). Value-based Purchasing Policies for Biologics.
