Last updated: February 23, 2026
What is the drug associated with NDC 62011-0268?
The National Drug Code (NDC) 62011-0268 corresponds to Xolair (omalizumab). It is a monoclonal antibody used to treat allergic asthma, chronic idiopathic urticaria, and other allergic conditions.
Market landscape overview
Market scope and indications
Xolair is approved by the FDA for several indications:
- Moderate to severe persistent allergic asthma (ages 6 and above)
- Chronic idiopathic urticaria (adults and adolescents aged 12 and above)
- Nasal polyps (approved in 2019)
The drug addresses approximately 7 million asthma patients in the U.S., with sales expected to grow due to expanded indications and increased diagnosis rates.
Competitive landscape
| Competitors |
Key Products |
Market Share (2022) |
Notes |
| Regeneron/Sanofi |
Dupixent (dupilumab) |
29% |
Growing due to multiple indications. |
| AstraZeneca |
Fasenra (benralizumab) |
12% |
Approved for eosinophilic asthma. |
| GSK |
Nucala (mepolizumab) |
8% |
Well-established in eosinophilic asthma. |
| Novartis |
Zolair (omalizumab biosimilars) |
Limited |
Biosimilar competition emerging. |
Market dynamics
- Growing prevalence of asthma and allergic conditions drives demand.
- Expanding labels for nasal polyps and chronic idiopathic urticaria expand the addressable patient pool.
- Biosimilar entry could impact pricing and market share reduction.
Price and revenue projections
Current pricing
List prices vary by formulation and dosage, typically:
- Injectable (150 mg): ~$700-$900 per dose
- Vial (per 300 mg dose): ~$2,100 to $2,700
Pricing variances exist based on insurance negotiations, discounts, and pharmacy benefit managers.
Revenue estimates (2023-2028)
| Year |
Estimated US Sales (USD Billion) |
Growth Rate |
Key Factors Influencing Growth |
| 2023 |
2.1 |
6% |
Increasing uptake, new indications |
| 2024 |
2.3 |
10% |
Label expansions, price adjustments |
| 2025 |
2.6 |
13% |
Biosimilar competition begins |
| 2026 |
2.9 |
12% |
Market penetration, improved diagnostics |
| 2027 |
3.2 |
10% |
New formulations, global expansion |
| 2028 |
3.5 |
9% |
Price escalation, market saturation |
Impact of biosimilars
Generic versions or biosimilars could enter the market by 2025-2026, potentially reducing prices by 20-40%. Their entry could drive diversification of distribution channels and lower out-of-pocket costs for payers and patients.
Pricing forecasts
- Year-over-year price increases are expected to average 2-3%, aligned with inflation and contractual negotiations.
- Biosimilar competition may force a 30% reduction in list prices but could lead to increased overall volume sales.
Regulatory and policy influence
- FDA approvals for extended indications expand market size.
- Pricing regulations in certain countries may limit increases.
- Insurance coverage is vital, with payers increasingly favoring biosimilars to control costs.
Key takeaways
- The drug's market size hinges on asthma and allergy prevalence.
- Competition from biologic rivals and biosimilars impacts pricing.
- Approximately $2.1 billion in U.S. sales in 2023, with growth driven by expanded indications.
- Biosimilar entry around 2025 could lead to significant price erosion.
- Future growth will depend on label expansions, market penetration, and policy/regulatory developments.
FAQs
1. How is the market share of Xolair expected to evolve?
Market share will likely decline modestly with the entry of biosimilars but remain significant due to brand recognition, expanded indications, and physician preference.
2. What factors could accelerate price reductions?
Biosimilar approvals, increased payer pressure, and formulary negotiations are primary factors leading to potential price reductions.
3. When might biosimilars impact the market?
Biosimilars for omalizumab are expected around 2025-2026, potentially reducing list prices by 30-40%.
4. How does label expansion affect revenue?
Label expansion into nasal polyps and other indications widens the patient base, increasing sales volume and revenue.
5. Are there global markets with significant growth potential?
Yes, emerging markets in Asia-Pacific and Latin America show growth potential due to increasing allergy and asthma prevalence and expanding healthcare investments.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] FDA. (2020). Xolair (omalizumab) approval details.
[3] EvaluatePharma. (2022). Global biologic market report.
[4] FDA. (2019). Nasal polyp approval for Xolair.
