Last updated: February 23, 2026
What Is the Drug with NDC 50419-0455?
The National Drug Code (NDC) 50419-0455 identifies a specific pharmaceutical product. According to the FDA's NDC directory, this NDC corresponds to "Enbrel (etanercept) single-dose prefilled syringe," administered for autoimmune diseases such as rheumatoid arthritis, psoriasis, and ankylosing spondylitis.
Market Landscape
Key Competitors
| Drug Name |
Category |
Market Share |
List Price (USD) |
Annual Sales (USD) |
| Enbrel (etanercept) |
Tumor necrosis factor blocker |
60% |
1,300 per syringe |
5.8 billion (2022) |
| Humira (adalimumab) |
Monoclonal antibody |
20% |
2,200 per pen |
21.3 billion |
| Remicade (infliximab) |
Monoclonal antibody |
8% |
1,600 per vial |
2.7 billion |
Market Size and Growth
The biologics segment for autoimmune therapy exceeds $50 billion worldwide, with Enbrel holding a dominant share among TNF inhibitors. Growth in biologics is driven by patent expirations for competitors, expanded label indications, and increased adoption in developing markets.
Patents and Exclusivity
Enbrel’s patent portfolio has faced patent cliffs; however, its core composition-of-matter patent expired in 2028. Patent protections for formulation and delivery methods still provide market exclusivity until 2030-2032, depending on jurisdiction.
Regulatory Considerations
- FDA approvals for additional indications broaden the potential market.
- Biosimilar entry expected post-2028, increasing price competition.
Price Projections (Next 5 Years)
Assumptions
- Current list price: $1,300 per syringe.
- Annual price inflation: 3% (reflecting manufacturer pricing strategies).
- Biosimilar impact: Initiation of US biosimilar approvals and market entry around 2028.
- Market penetration of biosimilars: 30% within the first two years of entry.
- Total addressable market remains steady, with slight growth assumptions due to expanded indications.
Price Trajectory
| Year |
Estimated List Price (USD) |
Notes |
| 2023 |
1,300 |
Current pricing |
| 2024 |
1,339 |
3% inflation |
| 2025 |
1,379 |
Continued price adjustments |
| 2026 |
1,420 |
No biosimilar impact yet |
| 2027 |
1,462 |
Biosimilar market entry approaches |
| 2028 |
1,504 |
Biosimilar approvals, potential price decrease |
| 2029 |
1,354 (70% of original) |
Biosimilars gain market share, price drops |
| 2030 |
1,208 |
Biosimilar market share at 30% |
Note: Price reductions post-biosimilar entry are based on typical discounts of 20-40%. Actual reductions depend on negotiated discounts, payer contracts, and market dynamics.
Revenue Considerations
- Historically, Enbrel maintains roughly 90% of its revenue through branded sales during the early biosimilar phase.
- Projected revenue declines due to biosimilar competition could reduce the drug's sales by 20-40% over the next decade unless new indications or formulations expand the market.
Implications for Stakeholders
- Manufacturers: Must invest in biosimilar development or new formulations to mitigate revenue loss.
- Investors: Should monitor biosimilar approval timelines and patent litigation outcomes.
- Healthcare Providers: Will observe shifts toward biosimilars, affecting prescribing patterns and reimbursement.
Key Considerations
- Patent expiry in 2028 will significantly influence pricing and market share.
- Biosimilar market entry is anticipated to reduce prices by 30-50%.
- Regulatory developments and negotiations with payers will shape future price and volume trajectories.
Final Summary
ND C 50419-0455, identified as Enbrel, has a stable market position with high brand loyalty. Pricing is currently at approximately $1,300 per syringe, with gradual increases aligned with inflation until biosimilar competition emerges post-2028. Biosimilar entry will likely precipitate a significant price decline and volume shift, impacting revenue projections. Market growth will depend on expanding indications and geographic expansion beyond established markets.
Key Takeaways
- Enbrel remains a leading TNF inhibitor with over $5 billion in annual sales.
- Price forecasts forecast a steady increase until 2028, followed by a potential 30-50% decline.
- Patent expiration in 2028 will be a pivotal event influencing market dynamics.
- Biosimilar competition will be the primary factor affecting future price and revenue.
- Strategic planning is essential for stakeholders to navigate patent cliffs and biosimilar entry.
FAQs
Q1: When does patent expiration for Enbrel occur?
A1: The core composition-of-matter patent expired in 2028, with secondary patents extending protections until 2030–2032.
Q2: What is the typical price discount for biosimilars?
A2: Biosimilars generally discount the reference product by 20–40%.
Q3: How do biosimilars impact market share?
A3: Biosimilars can capture up to 70% of the market within 2–3 years post-entry, especially when priced significantly lower.
Q4: Are there any upcoming regulatory events affecting Enbrel?
A4: Pending biosimilar approval and potential additional indications could influence demand.
Q5: How does geographic expansion influence revenue?
A5: Entering new markets, particularly in Asia and Latin America, can offset revenue declines in mature markets.
References
[1] U.S. Food and Drug Administration. (2022). Drug Listing Directory.
[2] EvaluatePharma. (2022). World Preview of Biologics and Biosimilars.
[3] patents.google.com. (2022). Enbrel patent information.
[4] IQVIA. (2022). PharmMetrics and sales volume data.
