Last updated: February 19, 2026
What is NDC 31722-0023?
NDC 31722-0023 corresponds to Repatha (evolocumab), a monoclonal antibody targeting PCSK9 used for hyperlipidemia and familial hypercholesterolemia. It is approved for reducing LDL cholesterol levels in adults at high cardiovascular risk.
Market Overview
Market Size
The global PCSK9 inhibitors market, dominated by Repatha and Praluent (alirocumab), was valued at approximately $3.5 billion in 2022. It is projected to grow at 20% annually through 2027, driven by expanding indications, label updates, and growing cardiovascular disease prevalence.
Key Drivers
- Increasing rates of hyperlipidemia and CVD
- Broader FDA approvals, including use in heterozygous familial hypercholesterolemia (HeFH)
- Rising adoption of personalized medicine
- Reimbursability improvements in major markets (U.S., EU)
Competitor Landscape
Repatha faces competition from:
- Alirocumab (Praluent)
- Inclisiran (Leqvio), a small interfering RNA therapy
- Statins and lipid-lowering agents
Market share distribution (2022): Repatha holds roughly 70% of the PCSK9 inhibitor market, with Praluent capturing remaining share.
Price and Pricing Trends
Current Pricing
In the U.S., the list price for Repatha is approximately $6,600 per year after discounts and insurance adjustments. Actual net prices are lower due to rebates, patient assistance, and negotiated discounts, with estimates ranging from $3,000 to $4,000 annually.
Historical Price Trajectory
- 2015: Launch at about $14,000 per year
- 2017: Price reductions driven by payer negotiations and market entry of competitors
- 2020: Steady pricing around $6,500 to $7,000, with some payers negotiating further discounts
Comparative Pricing
| Drug |
List Price (USD/year) |
Estimated Net Price (USD/year) |
Market Share (2022) |
| Repatha (evolocumab) |
$6,600 |
$3,500–$4,000 |
70% |
| Praluent (alirocumab) |
$6,000 |
$3,000–$3,500 |
20% |
| Inclisiran |
$10,000 |
Unknown |
10% |
Regulatory and Reimbursement Dynamics
Repatha continues to expand approved indications and receives reimbursement support in key markets. The impact of biosimilars is limited currently, as no biosimilar versions are commercially available or approved in the U.S., but patent expirations are approaching.
Patent and Patent Expiry
The primary patents protecting Repatha extend until 2028–2030, with some extensions. Patent expiration may pave the way for biosimilar entrants, potentially reducing prices by 30–50% upon launch.
Reimbursement Landscape
The CMS and private payers use value-based assessments, with guidelines favoring PCSK9 inhibitors for high-risk populations. Pricing adjustments have responded to payer pressures and market competition.
Price Projection Outlook
| Timeline |
Expected Price Trend |
Rationale |
| 2023–2024 |
Stable or slightly declining |
Payer negotiations, competitive pressures |
| 2025–2026 |
Potential decline of 10–20% with biosimilar entry |
Patent disputes or biosimilar launches reduce prices |
| 2027–2028 |
More significant price drops possible |
Patent expiry, biosimilar market entry |
Factors Affecting Future Pricing
- Biosimilar development and approval timelines
- Reimbursement policy changes
- Market share shifts from competitors
- Price sensitivity of payers and providers
Strategic Considerations
Investors should watch patent litigation developments, biosimilar pipeline progress, and potential label expansions. Pharma companies may pursue value-based pricing agreements to stabilize revenue.
Key Takeaways
- Repatha dominates the PCSK9 inhibitor market, with net prices around $3,500–$4,000 annually in the U.S.
- Market growth driven by expanding indications; global CAGR ~20% until 2027.
- Price pressures from biosimilar competition expected after 2028, possibly reducing prices by up to 50%.
- Reimbursement policies remain favorable but are sensitive to negotiation and cost-effectiveness data.
- Ongoing patent expiry and biosimilar approvals are primary catalysts for future pricing adjustments.
FAQs
1. When does patent expiration for Repatha occur?
Current patents are set to expire around 2028–2030, opening the pathway for biosimilar competition.
2. How does biosimilar entry affect prices?
Biosimilars typically reduce prices by 30–50%, intensifying market competition.
3. What factors influence net prices?
Negotiations with payers, rebates, discounts, and patient assistance programs significantly impact net prices.
4. Are there any regulatory hurdles for biosimilars?
Yes, biosimilar approval requires demonstrating similarity in efficacy and safety, with approval pathways available in the U.S. and EU.
5. What is the outlook for Repatha’s market share?
Repatha maintains a leading share through established reimbursement and clinical guidelines; future share depends on biosimilar uptake and competitive dynamics.
References
- Market research reports, 2022.
- FDA approval documents, 2015–2022.
- IQVIA, 2022.
- EvaluatePharma, 2022.
- U.S. Patent and Trademark Office, 2023.
