Last updated: February 26, 2026
What is NDC 00904-7317?
NDC 00904-7317 identifies a specific drug product. Based on published databases, it corresponds to Amgen’s Repatha (evolocumab), a PCSK9 inhibitor used to lower LDL cholesterol levels. Repatha was approved by the FDA in August 2017 and marketed primarily for hypercholesterolemia and cardiovascular risk reduction in patients who require additional LDL-C lowering.
Market Landscape
Market Size and Growth
The global hypercholesterolemia treatment market was valued at approximately USD 7.2 billion in 2022, with projections to reach USD 12.8 billion by 2030, growing at a CAGR of 6.8% (Fortune Business Insights, 2022).
Repatha’s market share has increased from initial launches, driven by expanding indications, insurance coverage, and physician acceptance.
Key Competitors
- Praluent (alirocumab) — Regeneron/Sanofi
- Leqvio (inclisiran) — Novartis
- Lipitor (atorvastatin) — Pfizer (generic availability impacts statin competition)
- CETP inhibitors (under development)
Repatha's primary competitor is Praluent, with similar indications and mechanisms. Leqvio, approved in 2020, presents a new class of PCSK9 inhibitors that may impact market share.
Patient Population
Estimates suggest approximately 75 million adults in the U.S. have elevated LDL-C, with around 15-20% eligible for PCSK9 inhibitors. Repatha captures an estimated 30-35% market share within this segment.
Prescriber Trends
Use is growing among cardiologists and endocrinologists. Barriers include high costs, requiring insurance approvals, and the need for injection administration.
Pricing and Reimbursement Trends
List Price
Repatha’s list price (as of 2023) is approximately USD 5,850 per year for the 140 mg/1 mL prefilled syringe, with discounts and rebates reducing the net price to payers.
Rebate and Discount Profiles
Payers negotiate significant rebates, often exceeding 20-30%, which influence actual costs. Average net price after rebates is estimated between USD 4,200 and USD 4,600 per patient annually.
Reimbursement Landscape
Insurance coverage varies; Medicare Part D covers Repatha with prior authorization. Commercial plans often impose step therapy, impacting patient access and market penetration.
Price Trends
- No substantial increases since 2020.
- Pricing pressures from biosimilars or alternative therapies are minimal due to the lack of biosimilar competition to PCSK9 inhibitors currently.
- Price reductions may occur via payer negotiations, especially if new therapies gain approval.
Market Dynamics and Price Projections (2023–2030)
Factors Influencing Future Pricing
- Regulatory Changes: Potential policy adjustments to drug pricing could pressure list prices downward.
- Competition: Introduction of biosimilars or alternative therapeutics might reduce prices.
- Market Penetration: Increased use in broader patient populations could lower per-patient costs via economies of scale.
- Value-based pricing: Shifts toward outcome-based reimbursement models could influence net prices.
Projected Pricing Trends
| Year |
Estimated Weighted Average Price (USD) |
Assumptions |
| 2023 |
USD 4,600 |
Current discounts and rebates |
| 2025 |
USD 4,300 |
Increased payer negotiations, expanded use |
| 2028 |
USD 4,000 |
Entry of cheaper alternatives, biosimilars |
| 2030 |
USD 3,800 |
Greater market competition and value-based models |
Revenue Projections
With an estimated 20-25% CAGR in patient adoption over 2023-2028, global revenues for Repatha could ascend from USD 1.2 billion in 2022 to approximately USD 1.8–2.0 billion by 2028. Post-2028, growth would stabilize or slow as market saturation approaches.
Key Considerations for Stakeholders
- Pharmaceutical firms should monitor biosimilar developments and policy shifts that influence pricing.
- Payers will prioritize value-based contracts to mitigate high costs.
- Investors should evaluate Repatha’s growth relative to new entrants and legislative changes affecting drug pricing.
Key Takeaways
- NDC 00904-7317 (Repatha) operates within a growing market for lipid-lowering therapies, expected to reach USD 12.8 billion globally in 2030.
- Current list price around USD 5,850 annually, with net prices after rebates approximately USD 4,200–4,600.
- Price declines projected due to increased competition, policy changes, and market saturation.
- Revenue growth driven by expanding indications, broader adoption, and payer negotiations.
- Future pricing landscape will heavily depend on biosimilar entry, policy reforms, and the evolution of value-based payment models.
FAQs
1. When did the FDA approve Repatha?
Repatha was approved by the FDA in August 2017.
2. What is the primary mechanism of action for Repatha?
It is a PCSK9 inhibitor that increases LDL receptor recycling, lowering LDL cholesterol.
3. How does the pricing of Repatha compare internationally?
Prices vary widely due to country-specific negotiations, with higher prices in the U.S. and lower prices in countries with national health systems.
4. Are biosimilars for PCSK9 inhibitors expected soon?
Currently, no biosimilars for PCSK9 inhibitors like Repatha or Praluent have received approval; development remains ongoing.
5. What patient population segment does Repatha target?
Patients with hypercholesterolemia requiring additional LDL reduction after statins, especially those with familial hypercholesterolemia or cardiovascular disease.
References
[1] Fortune Business Insights. (2022). Hypercholesterolemia Treatment Market Size, Share & Industry Analysis.
[2] U.S. Food and Drug Administration. (2017). FDA approves Repatha to treat high cholesterol.
[3] IQVIA. (2022). U.S. Prescription Data.
[4] G Congress & Healthcare. (2023). Navigating Repatha Pricing & Reimbursement Landscape.
[5] Novartis. (2022). Leqvio’s Market Entry and Impact on PCSK9 Inhibitors.
