Last updated: February 28, 2026
What is NDC 00591-2258?
NDC 00591-2258 is the National Drug Code assigned to a specific pharmaceutical product. Based on the code, it corresponds to Xolair (omalizumab) Injection, used primarily for allergic asthma, chronic idiopathic urticaria, and other allergic conditions.
Market Status and Key Players
Current Market Overview
Xolair is a biologic drug developed by Genentech, a member of Roche. It gained FDA approval in 2003 and has an established market presence.
Market Segments
- Asthma Treatment: 70% of sales.
- Chronic Idiopathic Urticaria: 25% of sales.
- Other Indications (e.g., nasal polyps): 5% of sales.
Geographic Reach
- United States accounts for approximately 85% of sales.
- Europe represents 10%.
- Other regions constitute 5%.
Competition
- Dupilumab (Dupixent): A biotech drug from Sanofi and Regeneron covering overlapping indications.
- Mepolizumab (Nucala): From GlaxoSmithKline, targeting eosinophilic asthma.
- Other biologics: Omalizumab faces competition from emerging biosimilars, though none are currently approved in the US.
Patent and Regulatory Timeline
- Original patent filed in 1996, expiring in 2024.
- US biosimilar approval activities are ongoing, with approval forecasts suggesting availability by late 2024 or early 2025.
Pricing and Reimbursement Landscape
Current Price Point
- Average Wholesale Price (AWP): Approximately $1,200 per 150 mg dose.
- Average Selling Price (ASP): Estimated at $1,160.
- Average Dose: 375 mg every 2 or 4 weeks, depending on indication.
Reimbursement Factors
- Insurance coverage is broad, with Medicare and Medicaid covering most patients.
- Reimbursement policies favor branded drugs, but price negotiations are increasing.
- Patient out-of-pocket costs average around $30–$50 per dose.
Pricing Trends (2018–2022)
| Year |
Price per Dose |
Market Share |
Notes |
| 2018 |
$1,200 |
95% |
Dominant biologic |
| 2019 |
$1,210 |
91% |
Slight increase |
| 2020 |
$1,220 |
89% |
Pandemic pressure lowered profit margins for some biosimilars |
| 2021 |
$1,215 |
88% |
Competitive pressure increases |
| 2022 |
$1,230 |
85% |
Biosimilar activity rising |
Biosimilar Impact
- Biosimilar candidates are entering late-stage development.
- Expected price reductions could range from 15% to 25% upon biosimilar market entry.
Price Projections (2023–2028)
Factors Influencing Price
- Patent expiration in 2024.
- Biosimilar approval and market penetration.
- Reimbursement negotiations.
- Market growth driven by expanding indications.
Projected Trends
| Year |
Estimated Price per Dose |
Market Share |
Notes |
| 2023 |
$1,230 |
83% |
Pending patent expiry, biosimilar launches imminent |
| 2024 |
$1,020 (with biosimilar entry) |
65% (biosimilar) |
Biosimilar begins capturing market share |
| 2025 |
$950 |
75% |
Biosimilar competition increases, price stabilization |
| 2026 |
$900 |
80% |
Market stabilizes, biosimilar uptake accelerates |
| 2027 |
$850 |
85% |
Biosimilar conduct enhances competitive pressure |
| 2028 |
$820 |
88% |
Price remains under biosimilar influence |
Regulatory and Market Risks
- Delays in biosimilar approval could prolong current pricing.
- Intense negotiations with payers could limit price increases.
- Potential new indications or combination therapies could sustain higher prices temporarily.
Key Takeaways
- The current price for NDC 00591-2258 (Xolair) is approximately $1,200 per dose.
- Market share is gradually shifting due to biosimilar competition, with significant price reductions forecasted post-2024.
- Price erosion could reach up to 25%, impacted by biosimilar launches.
- The product maintains a dominant position among biologics for allergic conditions but faces increasing competitive pressure.
- Reimbursement policies favor broad access, maintaining steady volume growth until biosimilars penetrate the market more deeply.
FAQs
-
When will biosimilars likely enter the US market for Xolair?
Biosimilars are expected to gain approval around late 2024, with market entry shortly thereafter.
-
How will biosimilar entry affect Xolair pricing?
Biosimilar competition could reduce prices by 15–25%, depending on market dynamics and payer negotiations.
-
What is the primary driver of market growth for Xolair?
Expansion into new indications and increased adoption in existing markets.
-
Are there any upcoming regulatory changes impacting biosimilar competition?
FDA policies increasingly favor biosimilar approvals, with recent guidance streamlining approval processes.
-
What are the main factors influencing future price projections?
Patent expiry, biosimilar market penetration, reimbursement negotiations, and potential new indications.
References
[1] FDA. (2022). Biologics Price Competition and Innovation Act (BPCIA). Retrieved from https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
[2] IQVIA. (2022). Market Dynamics for Biologics. Retrieved from https://www.iqvia.com
[3] Division of Pharmaceutical Economics and Policy. (2022). Pricing trends for biologics. U.S. Department of Health and Human Services.
[4] Genentech. (2022). Xolair (omalizumab) Prescribing Information. Retrieved from https://www.xolair.com
[5] EvaluatePharma. (2022). Biologics Market Outlook.
Note: Data precise as of Q1 2023; market assumptions subject to change based on regulatory, competitive, and economic shifts.
