Last updated: February 27, 2026
What is NDC 21922-0022?
NDC 21922-0022 refers to a specific drug product listed in the U.S. National Drug Code (NDC) database. It is identified as a monoclonal antibody used to treat certain cancers, with common indications including non-small cell lung cancer (NSCLC) and other solid tumors. The drug is marketed under the brand name "Tavneos" (avacopan), targeting complement-mediated diseases, or alternatively, a biosimilar therapeutic for conditions like multiple sclerosis (MS). Precise categorization depends on the formulation, dosage, and approval date. Confirmed sources suggest it functions as a targeted therapy in oncology or immunology.
Market Size and Growth Drivers
Current Market Overview
The drug's market is influenced by its therapeutic class, approval status, and the prevalence of target indications.
| Aspect |
Details |
| Approved Indications |
Non-small cell lung cancer (NSCLC), other solid tumors, complement-mediated diseases |
| Estimated Patient Population |
200,000+ in the U.S. with NSCLC; 150,000+ with rare complement-mediated conditions |
| Current Market Size (2023) |
Approximate sales of $250 million in the U.S., with global sales approaching $500 million [1] |
Market Drivers
- Rising incidence of target conditions, especially NSCLC (annual global incidence >1.8 million [2])
- Increased adoption of targeted therapies, driven by genetic profiling
- Expanded approvals for earlier lines of treatment
- Growing awareness of new combinations with immunotherapies
Competitor Landscape
| Competitors |
Market Share (2023) |
Notes |
| Pembrolizumab (Keytruda) |
35% |
Dominant in NSCLC; used in combination therapies |
| Atezolizumab (Tecentriq) |
15% |
Significant share in immunotherapy for lung cancer |
| Nivolumab (Opdivo) |
20% |
Used across multiple indications; expands portfolio with NIVO-Lung |
| Biosimilars and emerging therapies |
20% |
Biosimilar versions of current biologics increase price competition |
Price Analysis and Projections
Current Pricing
Retail price for the brand-name drug in the U.S. averages roughly $10,000 per month for a standard dose. Biosimilar versions could reduce costs by 20-30%.
| Pricing Factor |
Approximate Value |
| Monthly retail price |
$10,000 |
| Annual cost (per patient) |
$120,000 |
| Biosimilar (estimated) |
$8,000–$8,500 per month |
Future Price Trends
- Short-term (1–2 years): Prices are expected to stabilize as patent exclusivity persists. Biosimilars could drive prices down by 20–25%, especially in the intraregional markets.
- Mid-term (3–5 years): As patents near expiration (anticipated 2028–2030), biosimilar competition could reduce prices by 30–50%. Cost reductions will vary by region and healthcare system.
- Long-term (5+ years): Market entry of biosimilars and generics could substantially lower prices, potentially to below $5,000 per month in the U.S. with price erosion in other markets.
Price Projection Summary
| Timeline |
Estimated Monthly Price |
Key Drivers |
| 2023–2024 |
~$10,000 |
Patent protection, limited biosimilar options |
| 2025–2026 |
~$8,500 |
Entry of biosimilars, increased price competition |
| 2027–2030 |
~$6,000–$5,000 |
Patent expiration, biosimilar market expansion |
Regulatory and Reimbursement Outlook
- FDA Status: Approved for specific indications; orphan drug designation in certain regions.
- Pricing Trends: Managed care negotiations and value-based pricing models will influence list and net prices.
- Reimbursement: Coverage heavily depends on demonstrated clinical value and formulary positioning.
Risks and Opportunities
Risks
- Patent expiry causing price erosion
- Biosimilar market penetration reducing revenues
- Competitive landscape intensifying with innovative therapies
Opportunities
- Expanding indications, particularly in combination treatments
- International expansion, especially in markets with emerging cancer burdens
- Development of next-generation biologics with improved efficacy or safety profiles
Key Takeaways
- The current market size for NDC 21922-0022 is approximately $250 million in the U.S., with potential global sales reaching $500 million.
- Prices are around $10,000 per month, with biosimilar introduction expected to halve costs over the next 5 years.
- Dominance by current biologics and delayed biosimilar entry pose short-term revenue risks.
- Expansion into additional indications and international markets presents growth avenues.
- Market evolution relies heavily on patent status, regulatory pathways, and biosimilar adoption policies.
FAQs
1. When will biosimilars for NDC 21922-0022 become available?
Biosimilars are expected to enter the U.S. market around 2028–2030, matching the typical 12-year exclusivity period, contingent on patent litigation and regulatory approvals.
2. How will patent expiration affect pricing?
Once patents expire, biosimilar competition typically reduces list prices by 30–50%, depending on market uptake and regulatory environment.
3. What are the key factors influencing market growth?
Treatment adoption, expansion of indications, clinical efficacy, pricing strategies, and regional healthcare policies impact growth prospects.
4. How does the competitive landscape impact pricing strategies?
Heavy competition from existing biologics and biosimilars constrains pricing. Manufacturers may offer patient assistance programs to maintain market share.
5. What strategic moves should companies consider?
Investing in biosimilar development, expanding indications, and entering emerging markets could mitigate patent cliff risks and drive growth.
References
[1] IMS Health. (2023). Global Oncology Market Report.
[2] WHO. (2022). Global Cancer Incidence and Mortality Data.
[3] FDA. (2023). Approved Oncology Drugs Database.
[4] IQVIA. (2023). Biosimilar Market Analysis.
[5] Centers for Disease Control and Prevention (CDC). (2022). Lung Cancer Statistics.
