Last updated: February 27, 2026
What is NDC 00536-1333?
NDC 00536-1333 corresponds to Xolair (omalizumab), a monoclonal antibody used to treat allergic asthma, chronic idiopathic urticaria, and other allergic conditions. Manufactured by Genentech, a Roche company, Xolair received initial FDA approval in 2003. It is administered via subcutaneous injection, typically every 2 to 4 weeks, depending on the indication.
Current Market Landscape
Market Size and Key Indications
- Asthma: Approved for moderate to severe allergic asthma in patients 6 years and older.
- Chronic Urticaria: Approved for adults and adolescents 12 years and older with chronic spontaneous urticaria inadequately controlled by H1 antihistamines.
- Market Value (2022): Estimated at approximately USD 2.4 billion globally, driven primarily by North American and European markets.
Major Competitive Dynamics
| Competitor |
Drugs |
Indications |
Market Share (2022) |
Key Features |
| Xolair |
Omalizumab |
Asthma, urticaria |
~85% |
First biologic for allergy indication |
| Lebrikizumab |
Daiichi Sankyo / Astellas |
Eczema, asthma |
Emerging |
Under regulatory review |
| Dupilumab |
Regeneron / Sanofi |
Asthma, atopic dermatitis, nasal polyps |
10% |
Multi-indication biologic |
Pricing Trends (2022-2023)
- Average Wholesale Price (AWP): USD 1,240 per injection.
- Average Sale Price (ASP): Estimated at USD 1,000 per injection.
- Reimbursement and Payer Coverage: High due to FDA approval for multiple indications; coverage varies by payer but generally favorable for approved uses.
Market Drivers
- Increasing prevalence of allergic asthma and chronic urticaria.
- Growing prescription rates driven by expanded indications.
- Advances in biologic therapies improving patient outcomes.
Market Constraints
- High drug acquisition cost imposes reimbursement challenges.
- Entry of biosimilars remains limited due to patent exclusivity and data protections.
- Competitive biologics with broader indications or improved administration.
Patent Timeline and Exclusivity
- Patent Expiration: The original composition patent for Xolair was expected to expire in 2025, with supplementary patents extending exclusivity through 2028.
- Regulatory Data Exclusivity: Until 2023/2024.
- Potential Biosimilar Entry: Likely post-2025, potentially impacting pricing.
Price Projections (2023-2028)
| Year |
Expected Average Price per Injection |
Key Factors |
Remarks |
| 2023 |
USD 1,000 |
Stable reimbursement, patent expiry near |
Minor price pressure expected without biosimilars. |
| 2024 |
USD 950 |
Competitive pressure, market saturation |
Slight reduction expected as biosimilars approach. |
| 2025 |
USD 850 |
Patent expiration, biosimilar launches |
Biosimilars could impact list prices and market dynamics. |
| 2026 |
USD 700 |
Increased biosimilar market penetration |
Price competition intensifies. |
| 2027 |
USD 650 |
Heightened biosimilar uptake |
Lowering of brand premium. |
| 2028 |
USD 600 |
Market normalization, biosimilar competition |
Further reduction as biosimilar market stabilizes. |
Note: These projections assume no significant policy shifts or innovations that would substantially alter the competitive landscape.
Strategic Implications
- Brand loyalty and patient management programs are crucial before biosimilar entry.
- Payers are likely to negotiate deeper discounts post-patent expiry.
- Market growth hinges on expanding indications and optimizing administration pathways.
Key Takeaways
- NDC 00536-1333 (Xolair) holds a dominant position in allergy-related biologics.
- The market was valued at USD 2.4 billion in 2022, with steady growth seen through increasing indications.
- Price per injection is approximately USD 1,000, expected to decrease gradually from 2024 onward.
- Patent expiry around 2025 will likely introduce biosimilars, intensifying pricing pressure.
- Market resilience depends on clinical value, payer coverage, and competition management.
FAQs
1. When will biosimilars likely enter the Xolair market?
Post-2025, after patent expiry and regulatory approval processes.
2. How will biosimilar entry impact prices?
Expect prices to decrease by 25-40%, depending on biosimilar market penetration and payer negotiation.
3. Are there approved biosimilars for Xolair?
As of 2023, no biosimilars have been approved in major markets, but filings are underway.
4. What are the key indications for Xolair?
Allergic asthma, chronic spontaneous urticaria in adults and adolescents, with potential expansion to other allergic conditions.
5. How does the market growth compare to other biologics?
Xolair's growth parallels other allergy biologics but is generally modest due to established competition and high costs.
References:
- FDA. (2022). Xolair (omalizumab) Prescribing Information.
- IQVIA. (2022). Global Biologic Market Data.
- Evaluate Pharma. (2022). Biologic Pricing and Market Outlook.
- U.S. Patent Office. (2022). Patent Expiry Dates for Xolair.
- Centers for Disease Control and Prevention. (2022). Asthma Prevalence Report.
