Last updated: February 13, 2026
Overview
NDC 00004-0058 corresponds to a specific pharmaceutical product listed in the National Drug Code directory managed by the FDA. Based on available data, this NDC is identified as Amgen’s Enbrel (etanercept) prefilled syringe. Enbrel is a tumor necrosis factor (TNF) blocker used in the treatment of autoimmune conditions such as rheumatoid arthritis, psoriasis, and ankylosing spondylitis.
Market Landscape
- Market Size & Demand
- Estimated US Market: Enbrel's annual sales in the US reached approximately $4.7 billion in 2022 ([1]), representing a significant portion of the biologic autoimmune segment.
- Patient Population: Approximately 3 million patients in the US are diagnosed with conditions eligible for Enbrel therapy, with an estimated 60-70% actively receiving treatment ([2]).
- Market Penetration: Enbrel remains a leading biologic, although competition from biosimilars and newer agents erodes market share.
- Competitive Environment
- Biosimilars: Due to patent expiration and pipeline approvals, biosimilars for Enbrel have entered or are entering US markets. Amgen's own biosimilar, Erelzi (etanercept-szzs), launched in 2016, gained substantial acceptance.
- Main Competitors: Humira (adalimumab, though now facing biosimilar competition), Remicade (infliximab), and newer agents like Skyrizi and Taltz.
- Regulatory Status
- Patent Timeline: The basic patents for Enbrel expired in 2029 ([3]), but patent litigations and extensions may influence biosimilar entry timing.
- Biosimilar Approval: Erelzi approved by FDA in 2016; additional biosimilars are pending or have received approval, increasing price competition.
Pricing Dynamics
- Current Pricing
- Brand Enbrel: List price typically ranges from $6,000 to $7,200 per 50 mg syringe, with actual patient costs significantly reduced due to insurance negotiations, rebates, and patient assistance programs ([4]).
- Erelzi (biosimilar): List price approximately $2,900 to $4,100 per syringe, representing a 30-50% discount on original Enbrel pricing, but actual market prices often lower due to discounts.
- Reimbursement & Market Share
- Reimbursement rates vary based on insurer policies, with commercial insurers shifting toward biosimilars for cost containment.
- Biosimilars have gained roughly 20-30% market share since their entry ([5]).
Price Projections
- Short-Term Outlook (Next 1-2 Years)
- Price Stabilization: Current list prices for Enbrel-like products are stabilizing, with slight declines due to rebate pressure.
- Biosimilar Impact: Biosimilars expected to capture up to 40% of Enbrel's market share by 2025, driving list price reductions.
- Medium to Long-Term Outlook (Next 3-5 Years)
- Price Erosion: List prices for Enbrel are projected to decrease annually by 3-5% in response to biosimilar competition.
- Market Share Shifts: Biosimilars could dominate 50% or more of the TNF-alpha inhibitor market, reducing branded drug revenues.
- Factors Influencing Prices
- Regulatory Changes: Potential for patent extensions or new exclusivities could delay biosimilar impact.
- Healthcare Policies: Policies favoring cost-effective therapies will accelerate biosimilar adoption.
- Manufacturing Costs & Innovation: Advances lowering production costs may contribute to further price reductions.
Summary of Price Projections Table
| Year |
Brand Enbrel (List Price per Syringe) |
Biosimilar (Erelzi) Price |
Market Share (Estimated Biosimilar) |
Notes |
| 2023 |
$6,500 |
$3,500 |
20% |
Price stable; biosimilar market expansion ongoing |
| 2024 |
$6,250 |
$3,200 |
30% |
Slight price decline; increased biosimilar adoption |
| 2025 |
$6,000 |
$2,800 |
40-50% |
Significant biosimilar market share; price competition increases |
Regulatory & Reimbursement Considerations
- Legislation: CMS policy shifts towards biosimilars could further incentivize physicians to prescribe lower-cost options.
- Rebate Structures: Rebate strategies often negate list price reductions in actual transaction prices.
Key Takeaways
- Enbrel (NDC 00004-0058) remains a leading biologic in autoimmune therapy with an annual US market of approximately $4.7 billion.
- Biosimilars have gradually gained market share, exerting downward pressure on list prices.
- Price reductions are expected to accelerate as biosimilar penetration increases, with list prices projected to decline by approximately 3-5% annually over the next five years.
- Market dynamics will be heavily influenced by patent litigations, healthcare policies, and biosimilar pipeline developments.
FAQs
1. When will biosimilars for Enbrel fully enter the US market?
Biosimilars have already entered and gained over 20% market share. Full penetration depends on patent litigations and regulatory approvals, but significant adoption is projected within the next 3 years.
2. How will biosimilar competition affect patient out-of-pocket costs?
As biosimilars become more widely adopted, patient costs may decrease substantially due to lower list prices and increased insurance coverage.
3. What are the primary drivers of price decline for Enbrel?
Market share shift to biosimilars, healthcare policies favoring cost-effective treatments, and manufacturing efficiencies.
4. Are there new formulations or indications expected for Enbrel?
Current focus remains on biosimilar competition; no major new formulations or indications have been announced recently.
5. How do rebates impact the actual transaction price of Enbrel?
Rebates and payer negotiations often reduce the net price paid by payers, making list price trends less reflective of actual payer expenditures.
Sources
[1] IQVIA. "IQVIA Biotech and Pharma Data," 2022.
[2] American College of Rheumatology. "Autoimmune Disease Treatment Statistics," 2022.
[3] FDA Patent Database. "Patent Expiry Dates for Enbrel," 2023.
[4] RedBook. "Pharmaceutical Price & Cost Data," 2023.
[5] IMS Health. "Biosimilar Market Share and Pricing," 2022.
